Prospective Double-blind Randomized Study Research Articles

Comparison of Granisetron and Dexamethasone in management of post operative nausea and vomiting (PONV) in laparoscopic gynaecological surgery

Background: Postoperative nausea and vomiting (PONV) is a common problem. It is more common inlaparoscopic surgery than in open surgery and following laparoscopic gynaecological surgery. PONVcauses patient discomfort and can prolong the time of hospital discharge.It causes potential hospitalburden and loss of unanticipated working time both for the patients and doctors. Management of thisproblem based on prevention rather than treatment. Various antiemetic drugs including steroids areeffective in the prevention of PONV but which one is better still now a debateable one. On the basis of thisfact there were numerous research, articles, analysis and publication work done all over the world. Objectives: Comparison of granisetron and dexamethasone to detect which one is better in managementof PONV after laparoscopic surgery. Method: The patient were selected after ethical committee approval. After informed written consent wehave selected 100 ASA- I & II patients undergoing general anaesthesia for laparoscopic gynaecologicalsurgery in a prospective double blind randomized study. Patients who had received opoids, NSAIDS,steroids or antiemetic agent before previous 4 weeks or who has known hypersensitivity to granisetron ordexamethasone. Patients were divided as group-A (granisetron) and Group-B(dexamethasone). 50 patientwere member of each group. Every patient got study drug during induction. Group-A got granisetron andgroup-B got dexamethasone for prevention of PONV. There were no differences in background factors orfactors related to anaesthesia, analgesics consumption, pain or side effects between groups. The data collectedin a fixed protocol form from the patient consented for the study. After collection of data were coded, edited,compiled and entered into computer system for analysis. The result will help to guide the anaesthesiologistspracticing in the third world countries like Bangladesh in the management of PONV. Results: The current study showed the intravenous injection of 8 mg dexamethasone, or 3 mg Granisetronhave similar effects on PONV prophylaxis in laparoscopic gynaecological surgery. These results of thecurrent study indicated that Dexamethasone is a suitable substitute for Granisetron. Conclusion: Dexamethasone and Granisetron are comparable in management of PONV. These drugsinjection before anesthesia induction have similar effects on nausea and vomiting prophylaxis afterlaparoscopic gynaecological surgery. Prophylactic use of dexamethasone should be routine to preventPONV because dexamethasone is cost effective than granisetron. JBSA 2020; 33(1): 36-42

The effect of post-operative ultrasound-guided transmuscular quadratus lumborum block on post-operative analgesia after hip arthroplasty in elderly patients: A randomised controlled double-blind study.

Background and Aim:The best analgesic technique after hip surgeries is a matter of debate. This clinical trial aimed to assess the effect of transmuscular ultrasound-guided quadratus lumborum (QL) block on post-operative analgesic consumption after hip arthroplasty in elderly patients.Methods:This prospective randomised double-blind study was carried out on 60 patients aged 60–80 years presented for total hip replacement under unilateral spinal anaesthesia. Patients were randomly allocated to one of two groups: A control group, receiving sham transmuscular QL block (QLB) (1 ml of normal saline), and a QL group, receiving real transmuscular QLB (30 ml of plain bupivacaine 0.25%). Post-operative morphine consumption (primary outcome), post-operative pain score (secondary outcome), time to the first request of rescue analgesia, patient's satisfaction and the occurrence of post-operative complications were measured.Results:Compared to the control group, the use of QLB in the second group significantly decreased intravenous morphine consumption postoperatively from 8.50 ± 3.06 mg to 5.60 ± 3.22 mg (P = 0.0007) with a significant prolongation of the time to the first call for analgesia (P < 0.0001). It also decreased the post-operative visual analogue score 4 h, 6 h and 8 h postoperatively (P < 0.05). However, there was no difference between both the groups regarding patient's satisfaction and the occurrence of complications (P > 0.05).Conclusion:The use of transmuscular QLB in patients undergoing total hip replacement decreased post-operative analgesic consumption and post-operative pain score and prolonged post-operative analgesia. It did not affect patients' satisfaction and occurrence of post-operative complications.

What is the optimal dose of intrathecal meperidine in open prostate surgery? A prospective double-blind randomized study.

This study was an analysis of the effect of different dosages of intrathecal meperidine (40 mg, 50 mg, 60 mg, and 70 mg) on hemodynamic parameters, the duration of neural blockade, and the incidence of meperidine-related side effects in patients who underwent an open prostatectomy. Sixty patients who underwent an open prostatectomy with combined spinal-epidural anesthesia were included. The patients were allocated to receive 1 of 4 different dosages of intrathecal meperidine (n=15 for each group): Group I: 40 mg, Group II: 50 mg, Group III: 60 mg, and Group IV: 70 mg. The duration of the block procedure, surgery duration, highest sensory block level, and anesthetic complications were recorded and analyzed. At 20 minutes after the spinal injection, the maximum sensory block level was T6 in Group I and II, and it was T5 in Group III and IV. The mean motor block scores at 20 minutes after the spinal injection were lower in Group I compared with the other groups (p<0.001 for all). The motor block duration was significantly shorter in Group I and II than in Group III and IV (p<0.001 for all). Surgeon satisfaction was greater in Group II, III, and IV compared with Group I (p<0.001 for all). Patient satisfaction was better in Group III and IV compared with Groups I and II (p<0.001 for all). Intrathecal meperidine at a dose of 60 mg exerted a sufficient analgesic effect with minimum side effects in patients undergoing open prostatectomy.

Ultrasonographic evaluation of the effect of recruitment maneuvers and positive end-expiratory pressure on diaphragmatic functions in obese patients undergoing laparoscopic sleeve gastrectomy: A randomized controlled study

ABSTRACT Purpose The aim of this study was to evaluate the effect of recruitment maneuvers (RMs) and positive end expiratory pressure (PEEP) on diaphragmatic function and atelectasis areas during pneumoperitoneum and the trendelenburg position in laparoscopic sleeve gastrectomy (LSG) patients. Methods This prospective double-blinded randomized clinical study was conducted on 69 obese patients undergoing LSG. Patients were randomly allocated to one of the three groups, Group I (control group) patients were mechanically ventilated without PEEP or RM, Group II received PEEP of 5 cmH2O, and Group III received 5 cmH2O PEEP, and intermittent four times RM consisting of maintaining airway pressure 40 cmH2O for 40 s. Primary outcome was diaphragmatic excursion (DE). Secondary outcomes were atelectasis area, Forced Vital Capacity (FVC), Forced Expiratory Volume in 1 s (FEV1), Peak Inspiratory Pressure (PIP), and any complications. Results DE decreased in all investigated groups after anesthesia induction till the end of procedure compared to pre-induction values, and it was statistically significant lower in control group compared to the two interventional groups with no significant difference between PEEP and PEEP+RM groups. Atelectasis volume according to lung aeration score was significantly increased in control group compared to the other two groups, while there was no statistical significant difference in PEEP+RM compared to PEEP in all the times except before induction of anesthesia there was no significant difference among the three groups. Conclusion The application of RM and PEEP are helpful for preserving DE and improving lung aeration during laparoscopic sleeve gastrectomy.

Comparison of pain on injection of newer formulation propofol and standard propofol with added lignocaine: A randomised double-blind prospective study

Background: The aim of the present prospective randomised double-blind clinical study was to compare the incidence of pain-free injection following the use of this new formulation (propofol with medium-chain triglycerides [MCT] and long-chain triglycerides [LCT]) with propofol dissolved in LCT with added 2% lignocaine in patients undergoing various surgical procedures under general anaesthesia.Methods: Sixty adult patients (age range 18–50 years) were randomised to receive either 20 mL propofol dissolved in a mixture of MCT–LCT [Group L (n = 30)] or 18 mL propofol dissolved in LCT with added 2 mL 2% lignocaine [Group S (n = 30)]. A specially trained clinical research investigator assessed the occurrence of injection pain using a four-graded pain scale.Results: There was no significant difference in propofol injection pain among patients who received either LCT propofol with added lidocaine, (Group S) (33.3%) or new formulation propofol (Group L) (30.0%) (P = 0.993).Conclusions: The newer formulation, MCT–LCT propofol, is equally effective vis-à-vis the conventional propofol with added lignocaine to reduce the incidence of pain, thereby eliminating the need for addition of another drug, lignocaine.

Comparison of intravenous and transtracheal lidocaine on hemodynamic changes in patients with hypertension following tracheal intubation: A double blind clinical trial

Abstract Background Hemodynamic changes following intubation can be reduced by lidocaine at the time of induction of anesthesia and during laryngoscopy to prevent complications such as myocardial ischemia, infarction and brain damage. The aim of this study was to compare the effects of intravenous lidocaine and transtracheal lidocaine on hemodynamic changes in patients with hypertension under medical treatment following tracheal intubation. Materials and methods In this prospective double-blind randomized clinical study, patients aged 40–70 years with hypertension who were candidates for general anesthetic surgery were randomly divided into three groups: A (intravenous lidocaine), B (transtracheal lidocaine) and C (placebo). Blood pressure and heart rate were record at 30 s after induction of anesthesia, 30 s after intubation and 3, 6 and 9 min after intubation. Results The results showed that the mean systolic blood pressure varied significantly between 3 groups at 30 s after induction (group A: 127.08 ± 10.08, group B: 134 ± 9.77 and group C: 123 ± 1.55 mmHg) (P = 0.007) and 30 s after intubation (group A: 154.42 ± 15.75, group B: 142.58 ± 8.63, group C: 158 ± 17.37 mmHg) (P = 0.001). The mean diastolic blood pressure was significantly different between 3 groups in 30 s after intubation (group A: 93.23 ± 13.7, group B: 87.92 ± 4.22 and group C: 98.09 ± 9.29 mmHg) (P = 0.003). The mean heart rate was significantly different between 3 groups in 30 s after intubation (group A: 81.65 ± 8.06, group B: 74.65 ± 6.22 and group C: 82.5 ± 7.16 bit/minutes) (P Conclusion Our results showed that use of lidocaine in hypertensive patients following tracheal intubation can results in a more stable systolic and diastolic blood pressure as well as heart rate. It should be noted that the use of lidocaine for the presence or absence of cardiac dysrhythmias showed no difference among the study groups.

167. Assessment of the efficacy of teriparatide (Forteo) in patients undergoing posterolateral lumbar spinal fusion: a double-blinded randomized pilot study

BACKGROUND CONTEXT Lumbar spinal fusion is an increasingly common procedure for treating degenerative diseases of the lumbar spine. Non-solid fusion, or pseudarthrosis, at one year is a common complication associated with poor clinical outcomes and need for revision surgery. The risk of pseudarthrosis depends on the number of levels fused, the fusion material, and patient risk factors (osteoporosis, smoking, diabetes, etc.). Although there are multiple options for bone graft and osteoinductive materials, all have their benefits, side-effects and cost. Teriparatide is an injectable recombinant analog of parathyroid hormone that has been well-studied in its treatment of osteoporosis. However, no clinical studies of its effect on spinal fusion in humans have been published to date. PURPOSE To analyze the effect of teriparatide treatment on posterolateral spinal fusion in adults with degenerative diseases of the lumbar spine. STUDY DESIGN/SETTING Multicenter prospective double-blinded randomized study. PATIENT SAMPLE 60-90 year-olds with degenerative scoliosis, spondylolisthesis, or spondylosis at two medical centers undergoing instrumented posterolateral instrumented fusion >2levels. Use of BMP was excluded. OUTCOME MEASURES Pseudoarthrosis, screw loosening, PJK by CT. VAS, ODI, and Eq5D. METHODS Prospective randomized double-blind placebo-controlled pilot study performed at two large academic centers, UCSF and McGill University (Montreal). Included patients were aged 60-90 years with degenerative lumbar disease who were scheduled to undergo two-level or greater posterolateral lumbar spinal fusion. Patients were randomized in a 2:1 (Forteo:Placebo) manner. Patient were dosed 2 weeks pre-op and 10 weeks post-op. Patient derived outcomes were collected pre-op, 3, 6, 9, and 12 months. Fusions at 1 year were analyzed by helical CT. RESULTS A total of 36 patients completed the study. 58.3% (n=21) received teriparatide. 42.8% (n=9) reported an adverse event. Fusion rate of all patients was 47.2% (n=17); the remaining 52.8% (n=19) demonstrated pseudoarthrosis at 1 year. Fourty-seven percent of patients receiving teriparatide had a pseudoarthrosis, while 60% of placebo had a pseudoarthrosis. VAS, ODI, and Eq5D improved in all groups but no significant difference was found between groups. CONCLUSIONS Teriparatide appears to provide minimal benefit of avoiding pseudoarthroses in 60-90 year-olds undergoing thoracolumbar fusions. Teriparatide appears to have a fairly safe side effect profile. Further larger scale studies are warranted, possibly with the addition of BMP and/or bisphosphonates. FDA DEVICE/DRUG STATUS Unavailable from authors at time of publication.

A prospective randomized double-blind trial of the efficacy of a bilateral lumbar erector spinae block on the 24h morphine consumption after posterior lumbar inter-body fusion surgery

BackgroundSpine surgery is associated with considerable postoperative pain and can be challenging to treat. A loco-regional technique suitable for spine surgery should cover the dorsal root of the spinal nerves at the levels where surgery is performed. The erector spinae block is a loco-regional technique with promising results and was recently described at the thoracic level. There are no randomized trials of this technique on a lumbar level. This study tests the hypothesis that the 24-h postoperative morphine consumption is significantly lower in patients undergoing posterior lumbar inter-body fusion surgery with a lumbar erector spinae (LUMBES) block when compared with a sham block.MethodsThis prospective randomized double-blind multicenter study will randomly allocate 80 adult patients undergoing elective posterior lumbar inter-body fusion surgery during general anesthesia to one of two groups as follows: (1) bilateral erector spinae block (20 mL 0.25% levobupivacaine) or (2) bilateral sham block (20 mL NaCl 0.9%). Our primary endpoint is 24-h postoperative morphine consumption. Secondary endpoints include 72-h morphine consumption, intraoperative sufentanil dosage, postoperative pain scores at regular time intervals both at rest and during movement, time to first postoperative mobilization, and the Quality of Recovery 40 survey score.DiscussionThe LUMBES trial is a pragmatic clinical study that will provide evidence of whether a bilateral lumbar erector spinae block is effective in reducing 24-h postoperative morphine consumption in patients undergoing lumbar inter-body fusion surgery. If this hypothesis is confirmed, this finding could contribute to more widespread implementation of this technique.Trial registrationLocal ethics committee B300201837508, ClinicalTrials.gov identifier: NCT03825198. Registered on 31 Jan 2019.

Oral Nutritional Supplementation in Picky Eating Children (P11-114-19)

Abstract Objectives This was a multicenter prospective randomized double-blind study with two parallel experimental groups (EXP GRPS) &amp; an open-labeled control grp (CON). Objective was to investigate the effect of two oral nutritional supplements (ONS) along with dietary counseling (DC) vs DC alone on growth among picky eating children from India, aged &gt; 24 m to ≤ 48 m over 90 days. Methods Study recruited 321 children [n = 107/grp] in ages mentioned above from urban/semi-urban India with a weight-for-height between 3rd–15th centile (WHO 2006) and picky eating behaviors. Subjects in the 2 EXP GRPS received a daily supplement of one of the two similar ONS [Pediasure (PDS) &amp; Pediasure Advance (PDS Adv)} along with DC for 90 days, whereas subjects in CON received only DC. Children in both EXP GRPS consumed min of 1 &amp; max to 2 servings of ONS/day &amp; there were 5 study visits (Day 1, 7, 30, 60, 90). Primary variable was the change in WHO weight-for-height centile from Day 1 to 90. Secondary variables included change in weight-for-age, height-for-age, BMI-for-age, MUAC-for-age, average intake of energy, macros &amp; micronutrients (using 24 hr. dietary recall) and change in appetite &amp; palatability score. Results Post 90 days, both EXP GRPS had significantly higher change in growth parameters like weight-for-height centile (P = 0.0086), BMI-for-age centile (P = 0.0214 &amp; P = 0.0203 for PDS &amp; PDS Adv respectively) &amp; weight-for-age centile (P = 0.0054) as compared to CON. PDS group reported a significant improvement in MUAC-for-age centile (P = 0.0241) vs CON post 90-days. Significant improvement in appetite score was reported by EXP GRPS (P = 0.0067 &amp; P = 0.0245 for PDS &amp; PDS Adv) vs CON. Significant improvement in avg. intake of energy, protein, fat, calcium, iron, vit C &amp; thiamine was observed for EXP GRPS vs CON for all visit days except day1. Nutrient &amp; energy intakes at baseline were lower than RDA's but ONS helped to fill the nutritional gaps at end of 90 days. There were no significant differences observed in the height-for-age and palatability score. Conclusions ONS's formulated with macro &amp; micronutrients along with DC are more efficacious in catch up growth vs DC alone post 90 days supplementation. Funding Sources Abbott Nutrition has funded this study.

Chronic adverse effects after axillary lymphadenectomy in breast cancer patients after weaker and stronger postoperative analgesia: Results of a prospective double-blind randomized study.

e23066 Background: Tramadol is commonly used for pain treatment, but it is not known if stronger postoperative analgesia has an effect on chronic adverse effects in breast cancer patients. The aim of this study was to compare the rate of chronic adverse effects after weaker and stronger postoperative analgesia. Methods: A prospective double-blind randomized study included 118 breast cancer patients receiving tramadol for pain relief after axillary lymphadenectomy from 2015 to 2018 (Study EUDRA CT: 2015-000992-28). All patients used one of two analgesic regimens for 4 weeks after lymphadenectomy. Patients with larger dose received 75/650 mg of tramadol with paracetamol every 8 hours and a group with lower dose received 37.5/325 mg of tramadol with paracetamol every 8 hours. All patients received for four weeks twice daily naproxen sodium 550 mg and once a day pantoprazole 20 mg. One year after surgery patients were evaluated for the presence of neuropathic pain, chronic pain, arm symptoms and lymphedema. The association between dose of tramadol and chronic postoperative adverse effects was evaluated using asymptotic z-test and chi-square test. Results: Neuropathic pain was more common one year in comparison to one month after lymphadenectomy (p = 0.0001). There was a trend for lower rate of neuropathic pain after stronger analgesia in comparison to weaker analgesia (p = 0.058). Chronic pain was present in 18% of patients one year after lymphadenectomy. There was no difference in rate of chronic pain after stronger and weaker postoperative analgesia. Patients had less arm symptoms after stronger analgesia than after weaker analgesia (p = 0.02). Furthermore, there was a trend for lower rate of lymphedema of forearm after stronger analgesia than after lower analgesia (p = 0.078). Conclusions: The patients who received stronger postoperative analgesia had a statistical trend for less often neuropathic pain in comparison to patients who received weaker analgesia. The patients who received stronger postoperative analgesia had less arm symptoms and better quality of life in comparison to patients who received weaker analgesia. Clinical trial information: EudraCT 2015-000992-28.

Comparison of Effects of Hemostatic Gelatin Sponge Impregnated with Ropivacaine versus Normal Saline Applied on the Transverse Process of the Operated Vertebrae on Postoperative Pain in Patients Undergoing Spinal Instrumentation Surgery: A Randomized Clinical Trial

Protocols for effective postoperative pain control in patients undergoing spinal surgery are not standardized. In our study, we compared the effects of hemostatic absorbable gelatin sponge impregnated with ropivacaine versus normal saline when applied to the transverse process of the operated vertebrae on the postoperative pain following instrumentation spine surgery. A prospective double-blind randomized study was conducted on 30 patients undergoing spine surgery. At the end of surgery, the hemostatic gelatin sponge was applied by the surgeon on the transverse process of the operated vertebra containing either ropivacaine 0.5% or normal saline NaCl 0.9. Pain was assessed using the visual analog scale (VAS) every 4 hours for 48 hours postoperatively in the 2 groups (ropivacaine vs. normal saline). The total amount of postoperative opioid use was also recorded. The VAS score was significantly lower in patients receiving hemostatic gelatin sponge impregnated with local anesthetics as compared with patients receiving gelatin sponge impregnated with normal saline 48 hours postoperatively; the mean total dose of meperidine given in the first 48 hours postoperatively was significantly lower (53.5 ± 51.0 mg) in patients receiving gelatin sponge impregnated with local anesthetics as compared with patients receiving hemostatic gelatin sponge impregnated with normal saline (140.5 ± 102 mg). Use of intraoperative hemostatic gelatin sponge impregnated with ropivacaine applied on the transverse process of the operated vertebrae intraoperatively resulted in decreasing the postoperative pain in patients undergoing lumbar instrumentation surgery as manifested by the decrease in the VAS score and the total dose of opioids.

Comparison of the efficacy of ropivacaine and ropivacaine with dexmeditomidine in post tonsilectomy pain relief after peritonsillar infiltration- A prospective randomized double blind study

Introduction: Post operative pain relief is desired goal after tonsillectomy, infiltration of local anesthetic with or without adjuvant can reduce post tonsillectomy pain. Objective: To compare the postoperative analgesic efficacy and side-effects of peritonsillar-infiltration of ropivacaine with or without dexmeditomidine. Materials and Methods: Sixty patients aged 4-14 years posted for tonsillectomy under GA were randomly assigned in two groups of 30 each. In group R: Inj. ropivacaine (0.5%) 0.2ml/kg and in group RD: Inj.ropivacaine (0.5%) 0.2 ml/kg + Inj. dexmeditomidine 1mcg/kg were infiltrated in peritonsillar fossa post tonsillectomy. Patient were monitored for post-operative pain using VAS score, CHEOPS score and Wong baker pain rating scale at 30 minute, 1hr, 2hr, 4hr, 10 hr, 16hr and 24hr, pain on deglutination, time to first analgesic requirement, total dose of analgesics requirement in 24 hr postoperatively, amount of bleeding and parent’s satisfaction score. Results: VAS score, CHEOPS and Wong baker pain rating scale were comparable in both the groups at 30 min, 1hr, 2hr (P >0.05) but it was significantly low in group RD as compared to group R at 4hr, 10hr, 16hr and 24hr (P Conclusion: We concluded, peritonsillar infiltration of ropivacaine with or without dexmeditomidine is effective method for post-tonsillectomy pain relief. Addition of dexmeditomidine was found to prolong duration, decrease analgesic requirement and improve parent’s satisfaction score. Keywords: Tonsillectomy, Visual analog score, CHEOPS, Wong baker pain rating scale, Ropivacaine and dexmeditomidine.

Comparação do bloqueio do canal adutor para analgesia em cirurgia artroscópica com ropivacaína isolada e ropivacaína + clonidina

Inadequate pain relief after anterior cruciate ligament reconstruction affects mobility leading to development of adhesions, weakened ligament insertion and muscle atrophy. Adductor canal block for postoperative analgesia preserves quadriceps strength. The present study was conducted to compare pain free period in patients undergoing arthroscopic anterior cruciate ligament reconstruction, receiving ultrasound-guided adductor canal block with ropivacaine alone and ropivacaine with clonidine. A prospective randomized double blinded study was conducted including sixty-three adult, ASA class I, II patients undergoing anterior cruciate ligament reconstruction. They were randomized into three groups: Group S - control group received adductor canal block with 30mL saline, Group R - ropivacaine group received adductor canal block with 30mL of 0.375% ropivacaine and Group RC - clonidine group received adductor canal block with 30mL of 0.375% ropivacaine with clonidine 1μg.kg-1. The primary aim was to compare the pain free period in patients receiving adductor canal block with ropivacaine alone or ropivacine with clonidine. The secondary outcomes were pain score at rest and movement, total analgesic requirement, sedation score and postoperative nausea and vomiting. The mean pain free periods were 20min, 384.76min and 558.09min for Group S, Group R and Group RC, respectively and this difference was statistically significant (p < 0.001). There was no significant difference between Group R and Group RC in terms of pain scores at rest and movement and total analgesic requirement. Addition of clonidine to ropivacaine in USG guided adductor canal block led to significant prolongation of pain free period though pain score at rest and movement, and rescue analgesic requirement, did not differ.

The effect of transversus abdominis plane block on acute and chronic pain after inguinal hernia repair. A randomized controlled trial

This prospective double-blind randomized study aimed at evaluating the short- and long-term postoperative analgesic efficacy of the ultrasound-guided tranversus abdominis plane (TAP) block in inguinal hernia repair under general anesthesia. Sixty patients undergoing inguinal hernia repair were allocated to TAP block with either ropivacaine 0.75% 20 mL or placebo 20 mL. Postoperatively, they had access to a patient-controlled analgesia (PCA) device administering 1 mg doses of morphine as rescue analgesia. Pain was assessed at rest and during movement with the numeric rating scale (NRS) score 3,6 and 24 hs postoperatively. Other variables recorded were intraoperative dose of remifentanil required to maintain systolic arterial pressure within 20% of baseline, mg of morphine used in the Post Anesthesia Care Unit (PACU) and total dose of morphine administered via the PCA device. Six months after surgery, the occurrence of chronic pain was assessed with the NRS score at rest and during movement. Patients were also asked to fill in the DN4 questionnaire to estimate the development of neuropathic pain. Patients who were administered ropivacaine demonstrated significantly less pain at rest and on movement, as expressed by NRS scores in comparison to patients in the placebo group. The former group also required less remifentanil intraoperatively, less morphine during the PACU stay and had lower morphine consumption through the PCA device. Six months after surgery, pain scores at rest and during movement were comparable between the two groups. At the same time DN4 scores were low and comparable between the two groups. Ultrasound-guided TAP block provided better pain control than placebo in the acute setting after inguinal hernia repair. However, the incidence of chronic pain was low and not significantly affected by the performance of the block.

Comparison of adductor canal block for analgesia in arthroscopic surgery with ropivacaine alone and ropivacaine and clonidine

Background and objectivesInadequate pain relief after anterior cruciate ligament reconstruction affects mobility leading to development of adhesions, weakened ligament insertion and muscle atrophy. Adductor canal block for postoperative analgesia preserves quadriceps strength. The present study was conducted to compare pain free period in patients undergoing arthroscopic anterior cruciate ligament reconstruction, receiving ultrasound-guided adductor canal block with ropivacaine alone and ropivacaine with clonidine.MethodsA prospective randomized double blinded study was conducted including sixty-three adult, ASA class I, II patients undergoing anterior cruciate ligament reconstruction. They were randomized into three groups: Group S – control group received adductor canal block with 30 mL saline, Group R – ropivacaine group received adductor canal block with 30 mL of 0.375% ropivacaine and Group RC – clonidine group received adductor canal block with 30 mL of 0.375% ropivacaine with clonidine 1 μg.kg−1. The primary aim was to compare the pain free period in patients receiving adductor canal block with ropivacaine alone or ropivacine with clonidine. The secondary outcomes were pain score at rest and movement, total analgesic requirement, sedation score and postoperative nausea and vomiting.ResultsThe mean pain free periods were 20 min, 384.76 min and 558.09 min for Group S, Group R and Group RC, respectively and this difference was statistically significant (p < 0.001). There was no significant difference between Group R and Group RC in terms of pain scores at rest and movement and total analgesic requirement.ConclusionAddition of clonidine to ropivacaine in USG guided adductor canal block led to significant prolongation of pain free period though pain score at rest and movement, and rescue analgesic requirement, did not differ.

Intravenous acetaminophen vs saline in perioperative analgesia with laparoscopic hysterectomy

Opioids are effective for the treatment of postoperative pain but can cause nausea and are associated with dependency with long-term use. Nonopioid medications such as acetaminophen offer the promise of decreasing these nondesirable effects while still providing patient comfort. The purpose of this study was to compare intravenous acetaminophen with placebo and to evaluate postoperative pain control and opioid usage after laparoscopic hysterectomy. We conducted a prospective double-blind randomized study with 183 patients who were assigned randomly (1:1) to receive acetaminophen or placebo (Canadian Task Force Design Classification I). Patients received either 1000 mg of acetaminophen (n=91) or a placebo of saline solution (n=92) at the time of induction of anesthesia and a repeat dose 6 hours later. Both groups self-reported pain and nausea levels preoperatively and at 2, 4, 6, 12, and 24 hours after extubation with the use of a visual analog scale with a score of 0 for no pain to 10 for highest level of pain. Patients self-reported pain, nausea, and postoperative oral opiates that were taken after discharge. All opiates were converted to milligram equivalents of oral morphine for standardization. There were no significant differences in generalized abdominal pain at any time point postoperatively that included 2 hours (placebo 3.6±2.5 vs acetaminophen 4.4±2.5; P=.07) and up to 24 hours (placebo 3.3±2.4 vs acetaminophen 3.6±2.5; P=.28). Similar results were observed for nausea scores. There were no differences in opioid consumption at any time point including intraoperatively (placebo 4.4±3.9 vs acetaminophen 3.3±4.0; P=.06), post anesthesia care unit (placebo 10.5±10.3 vs acetaminophen 9.7±10.3; P=.59), and up to 24 hours after surgery (placebo 1.4±2.0 vs acetaminophen 1.6±2.1; P=.61). There were no differences in demographics or surgical data between groups. There was no difference between acetaminophen and placebo groups in postoperative pain, satisfaction scores, or opioid requirements. Given the relatively high cost ($23.20 per dose in our study), lack of benefit, and available oral alternatives, our results do not support routine use during hysterectomy.

The efficacy and tolerability of Avaricon® hemor medical preparation in the treatment of hemorrhoids compared to placebo – a prospective double blind randomized clinical study

Introduction. Despite the high incidence of hemorrhoidal disease and the widespread use of numerous topical preparations, there is still a lack of information regarding their efficacy. Therefore, the aim of this study was to assess the efficacy and tolerability of a new topical medical preparation containing sodium hyaluronate, calendula extract, hamamelis extract and mentha piperita essential oil as major components. Material and Methods. This prospective double-blind randomized clinical study included 49 patients with a diagnosis of hemorrhoidal disease. The patients were randomly assigned to two groups: Avaricon? group that included patients who applied 0.20% Avaricon? Hemor and a placebo group who applied placebo during 2 weeks. The effects of Avaricon? Hemor on the symptoms of hemorrhoidal disease, its safety, tolerability as well as compliance and adherence of study patients were analyzed. Results. Our results showed that Avaricon? Hemor was significantly superior to placebo in controlling most symptoms of hemorrhoidal disease. Conclusion. The tested medical agent showed to be effective with good tolerability and safety profile indicating its possible use in various therapeutic protocols in the management of hemorrhoidal disease.

A comparative study of midazolam alone or in combination with dexmedetomidine or clonidine for awake fiberoptic intubation

Background:Awake fiberoptic intubation (AFOI) is the gold standard technique for managing patients with anticipated difficult airway. Conscious sedation is desirable, not only to make the procedure more tolerable and comfortable for the patient but also to ensure optimal intubating conditions. Ideal sedation regime for AFOI should provide comfort, cooperation, hemodynamic stability, and amnesia along with maintenance of spontaneous respiration. Several sedative agents have been assessed over the past two decades for this purpose but α2 agonists appear to be the favorable choice owing to its sedative, analgesic, amnestic, and sympatholytic properties along with good hemodynamic profile.Aims:The present study has been aimed to recognize the characteristics of dexmedetomidine, clonidine, and midazolam and to compare their efficacy in providing optimal intubating conditions as well as hemodynamic stability during AFOI.Settings and Design:A prospective double-blind randomized study done in tertiary care hospital.Materials and Methods:Sixty patients of American Society of Anesthesiologists physical status Classes I and II aged 18–60 years with anticipated difficult airway were randomly allocated into three groups. All the patients received injection midazolam bolus followed by sedation infusion of midazolam, dexmedetomidine, and clonidine according to the allocated group. Primary outcome includes the time to achieve Ramsay Sedation Score (RSS) ≥2, time taken in intubation, intubation score, comfort score for fiberoptic insertion and intubation, and patient tolerance after intubation. The secondary outcome was hemodynamic, and respiratory variables include changes in heart rate (HR), mean arterial pressure (MAP), oxygen saturation (SpO2), and respiratory rate during the procedure.Statistical Analysis:All data were recorded, summarized, tabulated, and statistically analyzed using SPSS 16.0 version (Chicago, Inc., USA). The data were presented in mean ± standard deviation. P < 0.05 was considered as statistically significant.Results:All the three groups were comparable in terms of demographic profile. Time to achieve RSS ≥2 and mean intubation time was significantly less in Groups D and C as compared to Group M (P < 0.001). Among groups, Group D took least time to achieve RSS ≥2 (5.53 ± 0.74) and mean intubation time (4.53 ± 0.91). Similarly, overall intubation score, comfort, and patient tolerance score were significantly more in Group M as compared to Groups D and C (P < 0.001). Among the groups, Group D achieved least intubation score (3.80 ± 0.67) and comfort score (2.53 ± 0.74). Although Groups D and C have a lower mean HR and MAP during the procedure and intubation compared to Group M, the incidence of SpO2 is most frequent with clonidine.Conclusions:Patients who received α2 agonist were calmer and cooperative with less pain and discomfort than the patients who received midazolam. Dexmedetomidine allows better endurance, stable hemodynamics, and patent airway as compared to clonidine.

Optimal dose of tranexamic acid to prevent bleeding and to decrease transfusion demand in adolescent idiopathic scoliosis patients undergoing operative treatment

Introduction: Tranexamic Acid is an anti-fibrinolytic agent that has been studied previously to show the effect inreducing blood loss in major surgery. However, the dosage of the tranexamic acid has not been established. Methods: This is a prospective single-center double blind randomized study and was performed in the UKM Medical Centre. Total of thirty-six patients with Adolescence Idiopathic Scoliosis was consented and eligible to join the study. The patients were divided into two groups of eighteen patients and each group was given different doses of tranexamic acid. Blood investigation of hemoglobin, hematocrit, platelets, fibrinogen and D-dimer was conductedfor analysis, and blood loss perioperatively and blood transfusion provided were recorded and compared. Results: There was significant difference in blood loss and blood transfusion between the two groups. The group with high dose of tranexamic acid (50mg/kg) has less blood loss (20%) compared to the group with low dose (25mg/kg). The high dose group also showed reduced risk of blood transfusion (66%) compared to the low dose group. There was no significant difference between the two groups on the level of hemoglobin, hematocrit and platelets post-operatively. There was also no significant effect of tranexamic acid on fibrinogen and D-dimer that were assessedpre-operatively and postoperatively. No signs of reducing level of fibrin degradation products after bolus administration of tranexamic acid. Conclusion: High dose administration of tranexamic acid showed lower blood loss, hence lowering the demand of bloodtransfusion compared to the low dose.

Combination of palonosetron-dexamethasone is more effective than ondansetron-dexamethasone as single cisplatin antiemetic chemotherapy

Objective: To know the efficacy differences between two groups of drug combination ondansetron-dexamethasone (A) and ondan-setron-dexamethasone (B) to prevent emetic rsponses after chemotherapy cisplatin administration (CINV).Materials and Methods: A prospective double blind randomized clinical trial study held in Dr. Soetomo General Hospital involving 66 subjects, devide into two groups randomly 33 patients each. One group receive palonosetron-dexamethasone combination therapy compare to ondansetron-dexamethasone combination as standart therapy in gynecologic oncology Dr. Soetomo Hospital in a control group as cisplatin chemotharapy CINV prophylaxis. The research was conducted from June till October 2014 in the Dr. Soetomo General Hospital-Surabaya. Assessment and measurement of the response of nausea and frequency of vomiting according Gralla scale, changes in plasma density and electrolyte serum (Na, K, and Cl) as a result of dehydration caused by nausea and vomiting, as well as counting the onset of nausea and vomiting occur.Results: There was significant differences between the results of the combination therapy compared ondansetron-dexamethasone to palonosetron-dexamethasone for nausea and vomiting (p=0,001). 31 subjects suffers nausea in ondansetron group, while 9 subjects suffers nausea in palonosetron group. Vomiting occurs in 17 subjects from ondansetron group, and only 1 subject from palono-setron group during study. Changes in plasma density significant in palonosetron group, and natrium in ondansetron group. For K and Cl not significantly difference in both groups before and after cisplatin chemotherapy administration.Conclusion: Palonosetron-dexamethasone combination is super-ior as cisplatin CINV prophylaxis in response to nausea and vomiting frequency, and also give longer protection compare to ondansetron-dexamethasone significantly. The plasma density and electrolyte serum changes are varied in numbers and also influenced by many factors including physical status and nutrition, also intake of each patients.