Background Infusion Research Articles

Analysis of the current state of postoperative patient-controlled analgesia in Korea

Background: Patient-controlled analgesia (PCA) is a widely used method of postoperative analgesia with the advantage of tailored dosing for each individual. In spite of its popularity, there have been few reports on the current state of PCA in Korea. In this study, the data on PCA management and PCA regimens of medical institutions in Korea were collected and analyzed. Methods: Members of the Korean Society for Anesthetic Pharmacology were questioned as to the state of postoperative PCA management, such as acute pain services (APS) and pain assessment. A list of PCA regimens for each institution was also requested and analyzed. Results: Among 65 hospitals, APS was run in 30 and the severity of postoperative pain was assessed in 60. The safety and efficacy of PCA was evaluated only in 9 hospitals. A total 518 PCA regimens were reported (414, 95 and 9 regimens for intravenous, epidural and other routes, respectively). For intravenous PCA, fentanyl only and fentanyl-ketorolac regimens comprised 33.8 and 30.9% of treatments, respectively. In 95.9% of the regimens, background infusion was used. For epidural PCA, fentanyl-ropivacaine or fentanyl-levobupivacaine regimens made up the majority (47.4 and 13.7%, respectively). Conclusions: In Korea, APS was used in less than 50% of the hospitals and the evaluation of the safety and efficacy of PCA is not carried out in the majority. Background infusion, known to have little advantage in most cases, was widely used in intravenous PCA. Keywords: Patient-controlled analgesia; Postoperative pain

A new therapeutic option for postoperative pain management with oxycodone HCI injection.

Fentanyl is the most commonly used opioid analgesic in intravenous patient-controlled analgesia (IV PCA) in Korea. IV oxycodone was approved for postoperative IV PCA by the Ministry of Food and Drug Safety of Korea in 2013. The approved dosage regimen for postoperative pain relief with IV oxycodone is IV bolus loading of 2 mg followed by PCA composed of demand boluses of 1 mg and no background infusion with an oxycodone concentration of 1 mg/ml. However, a simulation study indicated that the minimum effective analgesic concentration (MEAC, as indicated by relief of pain by administering rescue analgesics) of oxycodone was reached most quickly with a higher loading dose of 0.1 mg/kg and IV PCA with background infusion. Oxycodone is a therapeutic option as an analgesic for postoperative pain management. It is necessary to reduce the analgesic dose of oxycodone in elderly patients because metabolic clearance decreases with age.

Comparison of oxycodone and sufentanil for patient-controlled intravenous analgesia after laparoscopic radical gastrectomy: A randomized double-blind clinical trial.

Background:Sufentanil is widely used for patient-controlled intravenous analgesia (PCIA). Oxycodone has a powerful analgesic effect and mild side effects. We conducted this study to compare the efficacy of oxycodone and sufentanil for PCIA on postoperative pain after laparoscopic radical gastrectomy.Methodology:A total of fifty patients scheduled for laparoscopic radical gastrectomy were equally randomized to receive postoperative pain treatment with either oxycodone (Group O) or sufentanil (Group S) for 48 h postoperatively. PCIA was set on demand mode without loading dose or background infusion. Postoperative cumulative sufentanil or oxycodone consumption, pain intensity, sedation status, and side effects were assessed.Results:No significant differences were detected in visual analog scale score at rest and during coughing in the two groups at various time points after operation. Group S was associated with more doses delivered by PCIA than Group O. The overall satisfaction degree was higher in Group O. The incidences of side effects were comparable between the two groups.Conclusion:Oxycodone is a valuable alternative for PCIA in patients undergoing laparoscopic radical gastrectomy.

Efficacy of Intravenous Patient-Controlled Analgesia (IV-PCA) using Fentanyl Compared with IV-PCA Using Morphine after Abdominal Surgery: A Prospective Randomized Study

Objective: To assess the efficacy and adverse effects of fentanyl intravenous (IV) patient-controlled analgesia (PCA) compared with morphine IV-PCA in patients after major abdominal surgery. Methods: In a prospective, randomized, observer-blinded study, 40 patients with ASA physical status I-II who were scheduled to undergo major abdominal surgery. A standard general anesthetic was administered. Patients were randomly divided into two groups for 24h postoperatively: 1) Group F with fentanyl concentration of 25 μg/mL, background infusion of 25 μg/h, bolus of 25 μg, and lockout time of 10 min; and 2) Group M with morphine concentration of 1 μg/ml, no background infusion, bolus of 1 mg, and lockout time of 10 min. Numerical rating scale (NRS) pain scores at rest and on coughing and dose of additional PCA bolus and supplemental analgesic, and the incidence of adverse effects were assessed postoperatively during the first 24 h postoperatively. Results: Compared to Group M, Group F showed significantly lower postoperative pain scores at rest throughout the observation period and on coughing at 2 h after the end of surgery. Incidence of nausea and median dose of antiemetic drugs were comparable between groups. No respiratory complications were encountered in this study. Patient satisfaction scores were significantly higher in Group F than in Group M. Conclusions: Fentanyl IV-PCA provides more effective postoperative pain relief than morphine IV-PCA and greater patient satisfaction after abdominal surgery, without increasing the incidence of adverse effects.

Comparison of effects of general anesthesia versus combined epidural-general anesthesia on postoperative complications in patients undergoing thoracic surgery

Objective To compare the effects of general anesthesia versus combined epidural-general anesthesia on postoperative complications in the patients undergoing thoracic surgery. Methods Two hundred twenty-one patients of both sexes, aged 18-80 yr, weighing 36-100 kg, of American Society of Anesthesiologists physical status Ⅰ-Ⅲ, scheduled for elective thoracic surgery, were randomly divided into either combined epidural-general anesthesia group(group GE, n=112)or general anesthesia group(group GA, n=109). The patients were further allocated to high-risk population and low-risk population.Anesthesia was induced with target-controlled infusion of remifentanil and iv injection of propofol, sufentanil and rocuronium.A double-lumen endotracheal tube was placed, and the patients were mechanically ventilated.Partial pressure of end-tidal CO2 was maintained at 30-40 mmHg.Anesthesia was maintained with inhalation of 1% sevoflurane, target-controlled infusion of remifentanil, iv infusion of propofol, and intermittent iv boluses of sufentanil.2% lidocaine 4 ml/h was infused epidurally in group GE, and normal saline 4 ml/h was given in group GA.Bispectral index value was maintained at 40-60 during surgery.Patient-controlled epidural analgesia(PCEA)was performed after surgery.PCEA solution contained 0.125% ropivacaine and sufentanil 0.5 μg/ml(in 250 ml of normal saline). The PCEA pump was set up to deliver a 2 ml bolus dose with a 20-min lockout interval and background infusion at 4 ml/h, and visual analogue scale(VAS)score was maintained less than 4.When VAS score ≥ 5, sufentanil 5 μg was injected intravenously as the rescue analgesic.The requirement for rescue analgesics after surgery, length of hospital stay after surgery, complications during postsurgical hospital stay(cardiovascular events, cardiac insufficiency, acute coronary syndrome, pulmonary infection, stroke, transient cerebral ischemic attack), and death within 30 days after surgery were recorded. Results Compared with group GE, the incidence of postsurgical cardiovascular events and atrial fibrillation was significantly decreased in group GA(P 0.05). Conclusion Compared with combined epidural-general anesthesia, general anesthesia alone provides lower occurrence of postsurgical complications for the patients undergoing thoracic surgery, and offers advantage for the high-risk patients having underlying diseases before surgery. Key words: Anesthesia, general; Anesthesia, epidural; Postoperative complications; Thoracic surgical procedures

Effect of direct current pulse stimulating acupoints of JiaJi (T10-L3) and Ciliao (BL 32) with Han's Acupoint Nerve Stimulator on labour pain in women: a randomized controlled clinical study

ObjectiveTo assess the clinical effect and safety of direct current (DC) pulse produced by Han's Acupoint Nerve Stimulator in reduction (HANS) of labor pain. MethodsTotally 120 participants were enrolled in this clinical trial, and were randomly divided into 4 groups including: HANS group, patient controlled intravenous analgesia (PCIA) group, patient-controlled epidural analgesia (PCEA) group and control group. The HANS group was treated by stimulating the acupoints of JiaJi (T10-L3) and Ciliao (BL 32) with DC pulse of 100 Hz and 15-30 mA produced by a portable battery-powered Han's Acupoint Nerve Stimulator for 30 min. The PCIA group was intravenously infused Ondansetron (8 mg) for 5 min, then tramadol injection (1.5 mg/kg) was slowly dripped by using BaxterAP II electronic pump with 50 mL tramadol (0.70%) + ondansetron (8 mg), background infusion 2 mL/h, PCA dose of 2 mL, lockout interval of 10 min. In PCEA group, women received intrathecal injection ropivacaine (3 mg) in L2-3, and epidural catheter was connected to BaxterAP II electronic pump, with 100 mL Ropivacaine (0.1%) and Sufentanil (50 ug), background infusion 5 mL, Patient controlled analgesia (PCA) dose of 5 mL, lockout interval of 10 min. The control group was not received analgesia. The visual analogue scale (VAS), stage and manner of labor, Apgar score of newborn, neonatal weights, oxytocin dosage, postpartum hemorrhage and side effects were monitored in all groups. ResultsThe vital signs were all stable in the four analgesic groups. After analgesia, there was statistical difference in VAS score between HANS group and control group, between PCEA group and the control group, between PCIA group and control group. The analgesic effect in the PCEA group was significantly better than that of other two groups. The second stage of labor in the PCEA group was longer than the other three groups, showing significant difference between them. The Apgar score of newborn 1min after birth in the PCIA group was slightly lower than that of the other two groups, showing significant difference between them. The neonatal weights between four groups were not significantly different. The rate of cesarean section in the control group was significantly higher than that of the labor analgesia group, there was statistically difference in four groups. The number of PCIA group that used oxytocin was lower than that of other three groups. There was no significant difference in postpartum hemorrhage between four groups. The side effects of the PCEA group were itching, uroschesis and neonatal asphyxia and PCIA group were nausea and vomiting and neonatal asphyxia. However, fewer side effects were observed in the HANS group. ConclusionThe DC pulse produced by HANS may be a non-pharmacological alternative to labor pain with fewer side effects.

Comparison of cellular immune function during postoperative analgesia with dezocine versus fentanyl in patients with gynecologic malignant tumors

Objective To compare the cellular immune function during postoperative analgesia with dezocine and fentanyl in the patients with gynecologic malignant tumors. Methods Fifty patients scheduled for elective surgery for gynecologic malignant tumors, of American Society of Anesthesiologists physical status Ⅰ or Ⅱ, were equally and randomly divided into either dezocine group (group D) or fentanyl group (group F) using a random number table.Total intravenous anesthesia was used for all the patients, and the intraoperatively administered anesthetics was the same.The patient-controlled intravenous analgesia (PCIA) was used for postoperative analgesia.PCIA solution contained dezocine 0.8 mg/kg and tropisetron 6 mg in 100 ml of normal saline in group D. PCIA solution contained fentanyl 0.01 mg/kg and tropisetron 6 mg in 100 ml of normal saline in group F. The PCA pump was set up to deliver a 1 ml bolus dose with a 15-min lockout interval and background infusion at 2 ml/h after a loading dose of 2 ml in the two groups.Tramadol 100 mg was given intravenously as rescue analgesic to maintain visual analogue scale score ≤ 4.Before surgery (T0), at the end of surgery, and at 24 and 48 h after surgery (T2, 3), venous blood samples were collected for detection of T lymphocyte subsets CD3+ , CD4+ , CD8+ and natural killer (NK) cell levels(by flow cytometry). CD4+ /CD8+ ratio was calculated.The requirement for rescue analgesics and occur-rence of adverse reactions such as nausea, vomiting, hypotension and respiratory expression were recorded after surgery. Results No patients required tramadol as rescue analgesic in either group.Compared with the value at T0, the levels of CD3+ , CD4+ and NK cells and CD4+ /CD8+ ratio were significantly decreased at T1, 2, and the CD8+ level was increased at T1 in group D, and the levels of CD3+ cells at T1, 2, CD4+ cells at T1 and NK cells at T1-3 were decreased (P 0.05). Compared with group F, the levels of CD3+ and NK cell were significantly increased at T3 (P 0.05). Conclusion The inhibitory degree of the cellular immune function is reduced when postoperative analgesia is performed with dezocine as compared with that when fentanyl is used in the patients with gynecologic malignant tumors. Key words: Analgesics, opioid; Fentanyl; Analgesia, patient-controlled; Immunity, cellular

Optimum ratio of medicine dosage for dexmedetomidine mixed with oxycodone used for PCIA after gastrointestinal surgery

Objective To investigate the optimum ratio of medicine dosage for dexmedetomidine mixed with oxycodone used for patient-controlled intravenous analgesia (PCIA) after gastrointestinal surgery. Methods Eighty patients of both sexes, aged 35–64 yr, weighing 55–75 kg, of American Society of Anesthesiologists physical status Ⅰor Ⅱ, undergoing elective gastrointestinal surgery, were randomly divided into 4 groups (n=20 each) using a random number table: oxycodone group (group O), and different ratios of medicine dosage when dexmedetomidine was added to sufentanil groups (OD1-3 groups). At 15 min before the end of surgery, oxycodone 0.1 mg/kg was injected intravenously, and PCIA pump was connected simultaneously.In group O, the PCIA solution contained oxycodone 1.00 mg/kg in 100 ml of normal saline.In group OD1, the PCIA solution contained oxycodone 1.00 mg/kg and dexmedetomidine 2.5 μg/kg in 100 ml of normal saline.In group OD2, the PCIA solution contained oxycodone 0.75 mg/kg and dexmedetomidine 2.5 μg/kg in 100 ml of normal saline.In group OD3, the PCIA solution contained oxycodone 0.50 mg/kg and dexmedetomidine 2.5 μg/kg in 100 ml of normal saline.The PCIA pump was set up to deliver a 0.5 ml bolus dose with a 15-min lockout interval and background infusion at 2 ml/h.Oxycodone 0.05 mg/kg was injected intravenously as a rescue analgesic, and visual analogue scale score was maintained≤4.The requirement for rescue analgesics was recorded.The requirement for the rescue analgesic was recorded within 48 h after surgery.The number of successfully delivered doses, and occurrence of adverse reactions such as bradycardia, hypotension, nausea, vomiting, over-sedation, somnolence, pruritus, and respiratory depression were recorded.Patient's satisfaction with analgesia was recorded at 72 h after surgery. Results No patients required the rescue analgesic or developed over-sedation, vomiting, respiratory depression and hypotension in the four groups.Compared with group O, the incidence of somnolence was significantly increased in group OD1, the incidence of nausea, somnolence, bradycardia and pruritus was decreased in OD2 and OD3 groups, and the degree of patient's satisfaction with analgesia was increased in OD1-3 groups (P 0.05). Compared with group OD2, no significant was found in the incidence of adverse reactions (P>0.05), and the degree of patient's satisfaction with analgesia was significantly decreased in group OD3 (P<0.05). The number of successfully delivered doses was significantly larger in group OD3 than in O, OD1 and OD2 groups (P<0.05). Conclusion Dexmedetomidine 2.5 μg/kg added to oxycodone 0.75 mg/kg is the optimum ratio of medicine dosage when used for PCIA after gastrointestinal surgery. Key words: Oxycodone; Dexmedetomidine; Analgesia, patient-controlled

Efficacy of oxycodone versus sufentanil for intravenous analgesia after radical resection of pulmonary carcinoma performed via video-assisted thoracoscope

Objective To compare the efficacy of oxycodone versus sufentanil for intravenous analgesia after radical resection of pulmonary carcinoma performed via video-assisted thoracoscope. Methods One hundred fifty-four patients of both sexes, aged 18–64 yr, with body mass index of 18–25 kg/m2, of American Society of Anesthesiologists physical status Ⅰ or Ⅱ, scheduled for elective radical resection of pulmonary carcinoma performed via video-assisted thoracoscope, were randomly divided into either sufentanil group (group S, n=76) or oxycodone group (group O, n=78) using a random number table.The 2 groups received combined intravenous-inhalational anesthesia.When postoperative visual analogue scale (VAS) score ≥ 4, sufentanil 5 μg or oxycodone 2 mg was injected intravenously, and the administration was repeated when necessary until VAS score ≤ 3.Patient-controlled intravenous analgesia(PCIA) was then used for postoperative analgesia (lasting for 48 h). PCIA solution contained tropisetron 20 mg and sufentanil 200 μg in 100 ml of normal saline in group S. PCIA solution contained tropisetron 20 mg and oxycodone 50 mg in 100 ml of normal saline in group O. The PCIA pump was set up to deliver a 2 ml bolus dose with a 10 min lockout interval and background infusion at a rate of 1 ml/h.VAS score was maintained ≤3.When VAS scores ≥4, morphine 10 mg injected intramuscularly was used as rescue analgesic.The requirement for rescue analgesic, level of patient's satisfaction with analgesia, and analgesia-related adverse events were recorded. Results The incidence of nausea and vomiting was significantly lower in group O than in group S (P 0.05). No patients developed respiratory depression and pruritus in the two groups. Conclusion Compared with sufentanil, oxycodone can produce similar analgesic efficacy when used for PCIA after radical resection of pulmonary carcinoma performed via video-assisted thoracoscope, with lower incidence of nausea and vomiting. Key words: Oxycodone; Sulfentanil; Pain, postoperative

Effect of patient-controlled intravenous analgesia with dexmedetomidine mixed with sufentanil on sleep quality after spinal surgery

Objective To investigate the effect of patient-controlled intravenous analgesia (PCIA) with dexmedetomidine mixed with sufentanil on the sleep quality after spinal surgery. Methods Eighty patients of both sexes, aged 21–72 yr, weighing 48–100 kg, of American Society of Anesthesiologists physical statusⅠ or Ⅱ, scheduled for elective spinal surgery, were randomly assigned into sufentanil group (group S) and dexmedetomidine mixed with sufentanil group (group DS) with 40 cases in each group.In group S, PCIA solution contained sufentanil 2 μg/kg and tropisetron 6 mg in 100 ml of normal saline.In group DS, PCIA solution contained sufentanil 2 μg/kg, dexmedetomidine 3 μg/kg and tropisetron 6 mg in 100 ml of normal saline.The PCA pump was set up with a 0.5 ml bolus dose, a 15 min lockout interval and background infusion at a rate of 2 ml/h.Sufentanil 5 μg injected intravenously and celecoxib 200 mg given orally were used as rescue analgesics, and numeric rating scale (NRS) score at rest was maintained ≤4 within 48 h after surgery.Ramsay sedation scores were recorded at 1, 2, 6, 12, 24 and 48 h after surgery.Sleep quality was evaluated using the Medical Outcomes Study Sleep Scale (MOS-SS), and the average time of daily sleep and Sleep Problems Index (SPI) were recorded at week 1 before and after surgery.Patient's satisfaction with sleep was assessed on the night of surgery and 1st day after surgery.The requirement for rescue analgesics was recorded. Results There was no significant difference in the requirement for rescue analgesics between group S and group DS (P>0.05). Compared with the value before surgery, the average time of daily sleep was significantly shortened, and SPI was increased at week 1 after surgery in group S (P 0.05). Compared with group S, the Ramsay sedation scores were significantly increased at 1, 2, and 6 h after surgery, the average time of daily sleep was prolonged at week 1 after surgery, the SPI was decreased at week 1 after surgery, and the degree of satisfaction with sleep was increased on 1st day after surgery in group DS (P<0.05 or 0.01). Conclusion PCIA with dexmedetomidine mixed with sufentanil is helpful in improving the sleep quality after spinal surgery in the patients. Key words: Dexmedetomidine; Sufentanil; Analgesia, patient-controlled; Sleep

Effect of Intraoperative and Postoperative Infusion of Dexmedetomidine on the Quality of Postoperative Analgesia in Highly Nicotine-Dependent Patients After Thoracic Surgery: A CONSORT-Prospective, Randomized, Controlled Trial.

Smoking is one of the most common addictions in the world. Nicotine inhalation could increase the risk of cardiorespiratory diseases. However, the solution that improved postoperative analgesia for highly nicotine-dependent patients undergoing thoracic surgery has not been specifically addressed.This CONSORT-prospective, randomized, double-blinded, controlled trial investigated the efficacy of combination of dexmedetomidine and sufentanil for highly nicotine (Fagerstrom test of nicotine dependence ≥6)-dependent patients after thoracic surgery.One hundred seventy-four male patients who underwent thoracic surgery were screened between February 2014 and November 2014, and a total of forty-nine were excluded. One hundred thirty-two highly nicotine-dependent male patients who underwent thoracic surgery and received postoperative patient-controlled intravenous analgesia were divided into 3 groups after surgery in this double-blind, randomized study: sufentanil (0.02 μg/kg/h, Group S), sufentanil plus dexmedetomidine (0.02 μg/kg/h each, Group D1), or sufentanil (0.02 μg/kg/h) plus dexmedetomidine (0.04 μg/kg/h) (Group D2). The patient-controlled analgesia (PCA) program was programmed to deliver a bolus dose of 2 ml, with background infusion of 2 ml/h and a lockout of 5 min, 4-hour limit of 40 ml, as our retrospective study. The primary outcome measure was the cumulative amount of self-administered sufentanil; the secondary outcome measures were pain intensity (numerical rating scale, NRS), level of sedation (LOS), Bruggrmann comfort scale (BCS), functional activity score (FAS), and concerning adverse effects.The amount of self-administered sufentanil were lower in group D2 compared with S and D1 groups during the 72 hours after surgery (P < 0.05), whereas the total dosage and dosage per body weight of sufentanil were significantly lower in D1 group than that of S group only at 4, 8, and 16 hours after surgery (P < 0.05). Compared with S group, the NRS scores at rest at 1, 4, and 8 hours after surgery and with coughing at 4, 8, 16, and 24 hours after surgery were significantly lower in D2 group (P < 0.05). However, compared with D1 group, the NRS scores both at rest and with coughing at 4 and 8 hours after surgery were significantly lower in D2 group (P < 0.05). The NRS scores both at rest and with coughing show that there were no significant differences between D1 group and S group at each time point after surgery (P > 0.05). LOS of group D2 was higher than S and D1 groups at 1 hour after surgery (P < 0.05), BCS of group D2 was higher than S and D1 groups at 4, 8, and 16 hours after surgery (P < 0.05), and FAS of group D2 was higher than S and D1 groups at 48 and 72 hours after surgery (P < 0.05). The number of rescue analgesia during 72 hours after surgery in D2 group was lower than S and D1 groups (P < 0.05). There were no significant differences among the 3 groups in terms of baseline clinical characteristics and postoperative adverse effects except for itching (P > 0.05).Among the tested patient-controlled analgesia options, the addition of dexmedetomidine (0.04 μg/kg/h) and sufentanil (0.02 μg/kg/h) showed better analgesic effect and greater patient satisfaction without other clinically relevant side effects for highly nicotine-dependent patients during the initial 72 hours after thoracic surgery.Trial Registration: chictr.org (ChiCTR-TRC-14004191).

The effect of adding a background infusion to patient-controlled epidural labor analgesia on labor, maternal, and neonatal outcomes: a systematic review and meta-analysis.

Patient-controlled epidural analgesia (PCEA) has gained popularity, but it is still unclear whether adding a background infusion confers any benefit. A systematic literature search in PubMed, Embase, CINAHL, LILACS, CENTRAL, Clinicaltrials.gov, and ISI WOS was performed to identify randomized controlled double-blind trials that compare PCEA-only with PCEA combined with a continuous infusion (PCEA + CI) in parturients. The data were subjected to meta-analyses using the random-effects model. Our primary outcome was the incidence of instrumental vaginal delivery. Secondary outcomes were incidences of spontaneous vaginal and cesarean deliveries, duration of labor, analgesic outcomes, maternal outcomes (visual analog scale scores for pain, maternal satisfaction, nausea, pruritus, hypotension), and neonatal outcomes (Apgar score, umbilical artery pH). We identified 7 trials with a low risk of bias, reporting on 891 parturients, for inclusion in our systematic review. The risk of instrumental vaginal delivery was increased in the PCEA + CI group, risk ratio (RR) 1.66 (95% confidence interval 1.08-2.56, P = 0.02; I = 0%); the RR for cesarean delivery was 0.83 (95% confidence interval 0.61-1.13, I = 0%). The second stage of labor was prolonged (weighted mean difference 12.3 minutes, 95% confidence interval 5.1-19.5 minutes, P = 0.0008; I = 0%) in the PCEA + CI group. Fewer patients in the PCEA + CI group required physician-administered boluses (RR 0.35 [95% confidence interval 0.25-0.47, P < 0.00001; I = 0%]). No differences regarding maternal adverse events (nausea, pruritus, hypotension) or neonatal outcomes (Apgar scores <7, umbilical artery pH) were observed. On the basis of current evidence, no conclusion can be drawn regarding the risks or benefits of adding a continuous background infusion to PCEA compared with PCEA-only epidural labor analgesia. Further high-quality studies involving a sufficient number of patients are required.

Stability of Reconstituted Telavancin Drug Product in Frozen Intravenous Bags

Intravenous (IV) infusions of telavancin for injection are generally administered in-hospital, but in some circumstances they may be administered in an outpatient environment. In that setting, antibiotics may be premixed and frozen. This study determined the chemical stability of nonpreserved telavancin in various commonly used reconstitution diluents stored in IV bags (polyvinyl chloride [PVC] and PVC-free) at -20°C (-4°F) without light. Telavancin (750 mg/vial) was reconstituted with 5% dextrose injection USP (D5W) or 0.9% sodium chloride injection USP (NS) to obtain drug solutions at approximately 15 mg/mL. Infusion solutions of telavancin at diluted concentrations of 0.6 mg/mL and 8.0 mg/mL covering the range utilized in clinical practice were prepared in both PVC and PVC-free IV bags using D5W or NS solutions. The infusion solutions were stored under frozen conditions (-20°C ± 5°C [-4°F ± 41°F]) and the chemical stability was evaluated for up to 32 days. Telavancin concentration, purity, and degradant levels were determined using a stability-indicating high-performance liquid chromatography (HPLC) method. Telavancin IV infusion solutions in D5W or NS at 0.6 mg/mL and 8 mg/mL and stored at -20°C (-4°F) met the chemical stability criteria when tested on days 0, 7, 14, and 32. The assayed telavancin concentration at each time point was within 97% to 103% of the initial mean assay value. The total degradants quantified by the HPLC stability-indicating method did not show any significant change over the 32-day study period. Telavancin IV infusion solutions (in D5W or NS) in both PVC and PVC-free IV bags were stable for at least 32 days when stored at -20°C (-4°F) without light. These results provide prolonged frozen stability data further to that previously established for 7 days under refrigerated conditions (2°C-8°C [36°F -46°F]), and for 12 hours at room temperature when diluted into IV bags containing D5W, NS, or lactated Ringer's solution.

Analgesic efficacy of two interscalene blocks and one cervical epidural block in arthroscopic rotator cuff repair.

Despite its effectiveness in other surgeries, studies on continuous epidural block in upper-extremity surgery are rare because of technical difficulties and potential complications. This study compared postoperative analgesic efficacy and safety of ultrasound-guided continuous interscalene brachial plexus block (UCISB) and fluoroscopy-guided targeted continuous cervical epidural block (FCCEB) in arthroscopic rotator cuff repair (ARCR). Seventy-five patients were randomly and equally assigned to groups FCCEB (0.2%), UCISB75 (0.75%), and UCISB20 (0.2%) according to the initial ropivacaine dose (8 ml). The background infusion (0.2% ropivacaine at 5 ml/h), bolus (3 ml of 0.2% ropivacaine), and lockout time (20 min) were consistent. Respiratory effects [respiratory discomfort (modified Borg scale), ventilatory function, and hemidiaphragmatic excursion (ultrasound)], analgesic quality [pain severity at rest and motion attempt (VAS-R and -M), number of boluses, analgesic supplements, and sleep disturbance], neurologic effects, procedural discomfort, satisfaction, and adverse effects were evaluated preprocedurally and up to 72 h postoperatively. FCCEB caused less respiratory depression and sensorimotor block, but had less analgesic efficacy than UCISBs (P < 0.05). FCCEB caused nausea, vomiting, and dizziness more frequently (P < 0.05) and had lower patient satisfaction than UCISBs (P < 0.05). UCISB75 can cause severe respiratory distress in patients with lung disorders. Other variables were not significantly different between the groups. UCISB20 may provide superior postoperative analgesia and is the most recommendable postoperative analgesic method in ARCR. Randomized controlled trials, Therapeutic study, Level I.

Patient controlled opioid analgesia versus non-patient controlled opioid analgesia for postoperative pain.

This is an updated version of the original Cochrane review published in Issue 4, 2006. Patients may control postoperative pain by self administration of intravenous opioids using devices designed for this purpose (patient controlled analgesia or PCA). A 1992 meta-analysis by Ballantyne et al found a strong patient preference for PCA over non-patient controlled analgesia, but disclosed no differences in analgesic consumption or length of postoperative hospital stay. Although Ballantyne's meta-analysis found that PCA did have a small but statistically significant benefit upon pain intensity, a 2001 review by Walder et al did not find statistically significant differences in pain intensity or pain relief between PCA and groups treated with non-patient controlled analgesia. To evaluate the efficacy and safety of patient controlled intravenous opioid analgesia (termed PCA in this review) versus non-patient controlled opioid analgesia of as-needed opioid analgesia for postoperative pain relief. We ran the search for the previous review in November 2004. For this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL 2014, Issue 12), MEDLINE (1966 to 28 January 2015), and EMBASE (1980 to 28 January 2015) for randomized controlled trials (RCTs) in any language, and reference lists of reviews and retrieved articles. We selected RCTs that assessed pain intensity as a primary or secondary outcome. These studies compared PCA without a continuous background infusion with non-patient controlled opioid analgesic regimens. We excluded studies that explicitly stated they involved patients with chronic pain. Two review authors independently extracted data, which included demographic variables, type of surgery, interventions, efficacy, and adverse events. We graded each included study for methodological quality by assessing risk of bias and employed the GRADE approach to assess the overall quality of the evidence. We performed meta-analysis of outcomes that included pain intensity assessed by a 0 to 100 visual analog scale (VAS), opioid consumption, patient satisfaction, length of stay, and adverse events. Forty-nine studies with 1725 participants receiving PCA and 1687 participants assigned to a control group met the inclusion criteria. The original review included 55 studies with 2023 patients receiving PCA and 1838 patients assigned to a control group. There were fewer included studies in our updated review due to the revised exclusion criteria. For the primary outcome, participants receiving PCA had lower VAS pain intensity scores versus non-patient controlled analgesia over most time intervals, e.g., scores over 0 to 24 hours were nine points lower (95% confidence interval (CI) -13 to -5, moderate quality evidence) and over 0 to 48 hours were 10 points lower (95% CI -12 to -7, low quality evidence). Among the secondary outcomes, participants were more satisfied with PCA (81% versus 61%, P value = 0.002) and consumed higher amounts of opioids than controls (0 to 24 hours, 7 mg more of intravenous morphine equivalents, 95% CI 1 mg to 13 mg). Those receiving PCA had a higher incidence of pruritus (15% versus 8%, P value = 0.01) but had a similar incidence of other adverse events. There was no difference in the length of hospital stay. Since the last version of this review, we have found new studies providing additional information. We reanalyzed the data but the results did not substantially alter any of our previously published conclusions. This review provides moderate to low quality evidence that PCA is an efficacious alternative to non-patient controlled systemic analgesia for postoperative pain control.

Optimum ratio of medicine dosage for dexmedetomidine mixed with sufentanil used for PCIA after Nuss procedure in pediatric patients with pectus excavatum

Objective To evaluate the optimum ratio of medicine dosage for dexmedetomidine mixed with sufentanil used for patient-controlled intravenous analgesia (PCIA) after Nuss procedure in pediatric patients with pectus excavatum. Methods Sixty pediatric patients diagnosed with pectus excavatum, aged 5-12 yr, weighing 18-50 kg, of ASA physical status Ⅰ or Ⅱ, scheduled for elective Nuss procedure under general anesthesia, were randomly divided into 3 equal groups using a random number table: different ratios of medicine dosage while dexmedetomidine was added to sufentanil groups (SD1-3 groups) . Postoperative analgesia was as follows: group SD1 received sufentanil 1 μg/kg + dexmedetomidine 2 μg/kg; group SD2 received sufentanil 1 μg/kg + dexmedetomidine 3 μg/kg; group SD3 received sufentanil 1 μg/kg + dexmedetomidine 4 μg/kg. A mixture of tropisetron 0.1 mg/kg and dexamethasone 0.1 mg/kg (in 100 ml of normal saline) was added in each group. The PCA pump was programmed to deliver 0.5 ml with a lockout interval of 15 min and background infusion at 2 ml/h. The PCA pump was connected immediately after the end of operation, and sufentanil with a dosage of 0.1 μg/kg was used as a rescue analgesic within 48 h postoperatively. The VAS score was maintained below 4. The requirement for rescue analgesics was recorded. The Ramsay sedation scores was recorded at 4, 8, 12, 24 and 48 h postoperatively, and the occurrence of adverse reactions such as nausea and vomiting, bradycardia, over-sedation, respiratory depression, agitation and shivering was recorded within 48 h after surgery. Results No pediatric patients developed nausea and vomiting, respiratory depression, bradycardia, over-sedation, and shivering. No pediatric patients required rescue analgesics in SD2 and SD3 groups. Compared with group SD1, the requirement for rescue analgesics and incidence of agitation were significantly decreased, and Ramsay sedation scores were increased at 4 and 8 h after operation in SD2 and SD3 groups. Ramsay sedation scores were significantly higher at 4 h after operation in SD3 group than in SD2 group. Conclusion Dexmedetomidine 3 μg/kg mixed with sufentanil 1 μg/kg is the optimum ratio of medicine dosage when used for PCIA after Nuss procedure in pediatric patients with pectus excavatum. Key words: Dexmedetomidine; Sufentanil; Funnel chest; Analgesia, patient-controlled

Effects of continuous femoral nerve block combined with infiltration anesthesia on postoperative analgesia in patients undergoing total knee arthroplasty

Objective To evaluate the effects of continuous femoral nerve block combined with infiltration anesthesia on postoperative analgesia in the patients undergoing total knee arthroplasty. Methods Ninety patients, aged 50-80 yr, weighing 45-90 kg, of ASA physical status Ⅰ-Ⅲ, scheduled for elective unilateral total knee arthroplasty, were randomly divided into 3 groups (n=30 each) using a random number table: continuous femoral nerve block + infiltration anesthesia group (group A) ; continuous femoral nerve block group (group B) ; continuous femoral nerve block + single sciatic nerve block group (group C) . The femoral nerve was catheterized for block before induction of general anesthesia in the three groups, and then a single sciatic nerve block was performed in group C. In group A, 20 ml mixture was injected into the posterior part of the joint capsule before prosthesis implantation, and 20 ml mixture was injected around the collateral ligaments and incision sites after prosthesis implantation and before closing.The mixture included ropivacaine 2.5 mg/ml, fentanyl 2.5 μg/ml, and methylprednisolone 1 mg/ml.In group B, 40 ml of normal saline was given as the method previously described in group A. Patient-controlled analgesia with 0.2% ropivacaine 250 ml was used for postoperative analgesia, lasting for 48 h. The patient-controlled analgesia pump was set up with a 5 ml bolus dose, a 30 min lockout interval and background infusion at a rate of 5 ml/h.Tramadol was used as rescue analgesic and was given orally to maintain the VAS score ≤ 5.VAS scores at rest were recorded at 4, 8, 12, 24 and 48 h after surgery, and VAS scores during activity were recorded at 8, 12, 24 and 48 h after surgery.The total consumption of tramadol within 48 h after surgery was recorded.The motor function of the affected extremity was assessed and scored at 12, 24 and 48 h after surgery, and the sensory and motor function was evaluated at 72 h after removal of the catheter.The occurrence of bleeding or exudates from the site of catheterization and adverse effects were recorded. Results Compared with group B or C, VAS scores at rest at 4-24 h after operation, VAS scores during activity at 8-24 h after operation, and the total consumption of tramadol were significantly decreased in group A. Compared with group B, no significant changes were found in motor block score of the affected extremity in group A. Compared with group C, the motor block score of the affected extremity was significantly decreased in A and B groups.There were no significant differences in the incidence of bleeding or exudates from the site of catheterization and nausea and vomiting between the three groups. Conclusion Continuous femoral nerve block combined with infiltration anesthesia can provide sufficient analgesia without influencing the recovery of sensory and motor function, and the safety is good for the patients undergoing total knee arthroplasty. Key words: Femoral nerve; Nerve block; Anesthesia, local; Pain, postoperative; Analgesia; Arthroplasty, replacement, knee

Optimization of insulin pump therapy based on high order run-to-run control scheme

Background and objectivesContinuous subcutaneous insulin infusion (CSII) pump is widely considered a convenience and promising way for type 1 diabetes mellitus (T1DM) subjects, who need exogenous insulin infusion. In the standard insulin pump therapy, there are two modes for insulin infusion: basal and bolus insulin. The basal-bolus therapy should be individualized and optimized in order to keep one subject's blood glucose (BG) level within the normal range; however, the optimization procedure is troublesome and it perturb the patients a lot. Therefore, an automatic adjustment method is needed to reduce the burden of the patients, and run-to-run (R2R) control algorithm can be used to handle this significant task. MethodsIn this study, two kinds of high order R2R control methods are presented to adjust the basal and bolus insulin simultaneously. For clarity, a second order R2R control algorithm is first derived and studied. Furthermore, considering the differences between weekdays and weekends, a seventh order R2R control algorithm is also proposed and tested. ResultsIn order to simulate real situation, the proposed method has been tested with uncertainties on measurement noise, drifts, meal size, meal time and snack. The proposed method can converge even when there are ±60min random variations in meal timing or ±50% random variations in meal size. ConclusionsAccording to the robustness analysis, one can see that the proposed high order R2R has excellent robustness and could be a promising candidate to optimize insulin pump therapy.

Efficacy of preoperative femoral nerve block for preemptive analgesia in elderly patients undergoing total knee arthroplasty under general anesthesia

Objective To evaluate the efficacy of preoperative femoral nerve block on preemptive analgesia in the elderly patients undergoing total knee arthroplasty under general anesthesia. Methods Sixty ASA physical statusⅠ-Ⅲ patients of both sexes, aged 65-75 yr, scheduled for elective total knee arthroplasty, were randomly divided into 3 groups(n=20 each)using a random number table: control group(group Ⅰ), preoperative femoral nerve block group(group Ⅱ)and postoperative femoral nerve block group(group Ⅲ). Single-injection femoral nerve block was performed with 0.375% ropivacaine 20 ml injected around the nerve under the guidance of ultrasound immediately before induction of anesthesia and at the end of surgery in Ⅱ and Ⅲ groups, respectively.Patient-controlled intravenous analgesia(PCIA)with sufentanil(background infusion 2 ml/h, bolus dose 2 ml, lockout interval 15 min)was used until 2 days after surgery, and VAS score was maintained ≤3.When VAS score>3, flurbiprofen axetil 50 mg was injected intravenously as rescue medication.The consumption of sufentanil per hour, requirement for rescue medication, and development of adverse reactions were recorded within 24 h after surgery.Sufentanil-sparing degree was calculated. Results Compared with group Ⅰ, the consumption of sufentanil per hour, requirement for rescue medication and the incidence of nausea and vomiting were significantly decreased within 24 h after surgery in Ⅱ and Ⅲ groups.The consumption of sufentanil per hour, requirement for rescue medication and the incidence of nausea and vomiting were significantly lower within 24 h after surgery in group Ⅱ than in group Ⅲ.The consumption of sufentanil per hour was decreased by 35% in group Ⅱ as compared with group Ⅰ, and decreased by 18% in group Ⅱ as compared with group Ⅲ. Conclusion Preoperative femoral nerve block can provide good preemptive analgesia in the elderly patients undergoing total knee arthroplasty under general anesthesia. Key words: Nerve block; Analgesia; Aged; Anesthesia, general; Arthroplasty, replacement, knee

Incidence and characteristics of breakthrough pain in parturients using computer-integrated patient-controlled epidural analgesia

IntroductionThe computer-integrated patient-controlled epidural analgesia (CIPCEA) system can automatically adjust the background infusion rate during combined spinal-epidural analgesia based on the parturient's need, as labor progresses. ObjectivesThe objective is to identify risk factors associated with breakthrough pain during labor as well as identify obstetric and fetal outcomes that are affected by breakthrough pain. DesignThis is a retrospective review of prospectively collected data. SettingThe setting is in a delivery room. ParticipantsThe participants are 280 nulliparous women in early labor (≤5 cm cervical dilatation) who received combined spinal-epidural analgesia with CIPCEA. InterventionsThe intervention is CIPCEA. MeasurementsThe primary outcome is the incidence of breakthrough pain (≥1 episodes of pain or pressure that required supplemental epidural medications) during labor. Relevant demographic, anesthetic, obstetric, and fetal characteristics were also measured. Univariate and multivariate analyses were performed to identify obstetric and anesthetic factors that were associated with increased incidence of breakthrough pain as well as to evaluate the impact of breakthrough pain on obstetric and fetal outcomes. ResultsThe incidence of breakthrough pain was 9.6%. Independent factors associated with incidence of breakthrough pain are the presence of dysfunctional labor, increased maternal body mass index, and decreased successful-to-total-bolus-demand ratio. The postlabor characteristics independently associated with breakthrough pain were increased duration of labor, decreased duration of effective analgesia, increased total local anesthetic consumption, and decreased maternal satisfaction. ConclusionsLow successful to total patient demand bolus ratio was the factor with the strongest association with breakthrough pain. Breakthrough pain was also associated with dysfunctional labor and poorer maternal satisfaction.