Prospective Double-blind Randomized Study Research Articles

Intravenous Clonidine versus Intraperitoneal Clonidine for Postoperative Analgesia After Total Abdominal Hysterectomy: A Randomised Controlled Trial.

ObjectiveThis prospective randomised double-blind study was conducted to compare the effect of intravenous (IV) with intraperitoneal (IP) administration of clonidine with respect to analgesic efficacy and side effects.MethodsA total of 60 American Society of Anaesthesiologists (ASA) physical status class I and II patients, aged 35–60 years, undergoing total abdominal hysterectomy, were randomly divided into 2 groups. Standard general anaesthesia technique was used. All the patients in group IV received 3 μg kg−1 of IV clonidine after resection of the uterus along with 0.25% bupivacaine (20 mL intraperitoneally and 10 mL as wound infiltration), whereas patients in group IP received 10 mL of normal saline intravenously and 3 μg kg−1 of clonidine mixed with 0.25% bupivacaine (20 mL intraperitoneally and 10 mL as wound infiltration). Postoperative analgesia was provided with IV diclofenac every 8 hours and IV fentanyl (1 μg kg−1) on demand. Pain at rest, opioid consumption, level of sedation and severity of nausea were recorded for 24 hours. The heart rate (HR) and blood pressure (BP) were recorded at an interval of 15 minutes for 2 hours followed by routine hourly monitoring.ResultsBoth the groups were found to be similar with respect to demography and ASA physical status. The maximum pain was felt at 6 hours in both the groups. The mean visual analogue scale score at 6 hours (p=0.47) was comparable. However, patients in group IV had significantly higher sedation (p<0.001) and nausea (p=0.013) scores on arrival at post-anaesthesia care unit along with a significant reduction in HR (p=0.001) and BP (p=0001) for the first 2 hours postoperatively.ConclusionAlthough IP clonidine is comparable with IV clonidine with respect to postoperative pain scores and supplementary opioid requirement, the side effects are significantly less with IP clonidine.

Effect of Epidural Bupivacaine Versus Intrathecal Single Dose inAnalgesia during Normal Vaginal Labor of Multiparous Women

AbstractBackground: Epidural analgesic technique is the mostcommonly used and most effective analgesia during labor.Intrathecal labor analgesia is alternatively and effective methodto provide labor analgesia.Aim of Study: To compare the effect of epidural bupi-vacaine versus single-dose intrathecal bupivacaine duringlabor of multiparous women on the duration of labor analgesia,progress of labor, block characteristics and side effects.Material and Methods: In a prospective randomizeddouble-blind study, 80 multiparous women of ASA class Iand II were randomly allocated into two groups of pregnantwomen 40 each. The spinal group received hyperbaric bupi-vacaine 0.5% at a dose of 3.75mg (0.75ml) of hyperbaricbupivacaine with 25ug fentanyl (0.5ml) and diluted withsterilized normal saline to 1.5ml whereas the epidural groupreceived isobaric bupivacaine 8-10ml of 0.125% bupivacainewith fentanyl 50mg. Patients were monitored for hemodynam-ics, sensory and motor block characteristics, side effects,duration of stages of labor and pain intensity was also recorded on a visual analogue scale.Results: Maternal hemodynamics showed a nonsignificantchanges between both groups. Onset of sensory block andduration were significantly delayed in epidural group incomparison to spinal group (8.80±5.27, 163±16.64min) vs (4.6± 1.20, 120.2±3.33min) and visual analogue scale comparable in both groups but scale was lower in the spinal group. Patient's satisfaction was insignificantly more in S group. The duration of the first and second stages of labor in the spinal group was shorter than that in the epidural group and incidence of maternal complications in both groups were insignificant.Conclusion: A safe and effective alternative method toepidural analgesia is a single-dose intrathecal bupivacaine.

Lung protective ventilation strategy to reduce postoperative pulmonary complications (PPCs) in patients undergoing robot-assisted laparoscopic radical cystectomy for bladder cancer: A randomized double blinded clinical trial

Study objectiveTo evaluate the effects of ventilation with low tidal volume and positive end-expiratory pressure (PEEP) on postoperative pulmonary complications in patients undergoing robot-assisted laparoscopic radical cystectomy (RARC) for bladder cancer. DesignA prospective randomized double-blinded study. SettingA single center trial in a comprehensive tertiary hospital from January 2017 to January 2019. PatientsA total of 258 patients undergoing RARC for bladder cancer. InterventionsPatients were randomly assigned to receive either lung-protective ventilation (LPV group) [tidal volume 6 ml/ kg predicated body weight (PBW) + PEEP 7 cmH2O] or nonprotective ventilation (control group) (tidal volume 9 ml/ kg PBW without PEEP) during anesthesia. MeasurementsThe primary outcome was the occurrence of postoperative pulmonary complications (PPCs) during the first 90 days after surgery. The secondary outcomes were extubation time, oxygenation index (OI) after extubation and at postoperative day 1 in blood gas. Main resultsThe incidence of PPCs at postoperative day1, 2 and 3 were lower in LPV group [26.8% vs. 47.2%, odds ratio (OR) 0.41, 95% confidence interval (CI), 0.24–0.69, P = 0.0007, 21.3% vs. 43.3%, OR 0.36, 95% CI, 0.20–0.61, P = 0.0002, 14.2% vs. 27.5%, OR0.43, 95%CI, 0.23–0.82, P = 0.0087, respectively], while no differences were observed at day 7 and 28 (3.9% vs. 9.4%, P = 0.0788, 0% vs. 1.6%, P = 0.4980, respectively). No PPCs were observed at postoperative day 90 in both groups. Furthermore, immediately after extubating and at postoperative day 1, OI was significantly higher in LPV group compared with control group [390(337–467) vs. 343(303–420), P = 0.0005, 406.7(73.0) vs. 425.5(74.7), P = 0.0440, respectively]. Patients in LPV group had a significant shorter extubation time after operation compared with control group [38(33–54) vs. 35(25–46), P = 0.0012]. ConclusionLPV combining low tidal volume and PEEP during anesthesia for RARC may decrease the incidence of postoperative pulmonary complications.

Transepithelial Laser versus Alcohol Assisted Photorefractive Keratectomy Safety and Efficacy: 1-Year Follow-up of a Contralateral Eye Study.

PurposeTo compare single-step transepithelial photorefractive keratectomy (TPRK) to conventional alcohol assisted epithelial removal then photorefractive keratectomy (AAPRK) regarding pain, epithelial healing, visual acuity, corneal haze measured subjectively and objectively, higher order aberrations changes, contrast sensitivity and vector analysis of astigmatic correction with one year follow-up.MethodsA prospective double-blind randomized study of 29 subjects (58 eyes) who underwent myopic aberration-free laser correction by smart pulse technology using Schwind Amaris 1050 Hz with 1-year follow-up. Right eye was randomly treated by AAPRK or TPRK. Postoperative assessment was performed on day 1 and 3, at 1st week, and 1st, 3rd, 6th, and 12th months. Patients were assessed for pain, epithelial healing, visual acuity, corneal haze, astigmatic correction, higher order aberrations and contrast sensitivity.ResultsEpithelial healing was complete by the 3rd day in 62.1% of AAPRK eyes and in 89.7% of TPRK eyes. First day postoperative pain was higher in TPRK group (p = 0.0134). The decimal uncorrected visual acuity at 12 months was 1.47 ± 0.39 and 1.57 ± 0.38 in the AAPRK and TPRK groups respectively (p = 0.3719). Post-photorefractive keratectomy haze reached a final level of 0.04 ± 0.14 and 0.02 ± 0.1 in AAPRK and TPRK groups respectively (p = 0.5607). Contrast sensitivity was comparable in low and high frequency cycles per degree. Vector analysis of astigmatic correction showed correction index at one year of 0.99 and 1.05 for AAPRK and TPRK groups respectively.ConclusionsAlcohol assisted and transepithelial photorefractive keratectomy have comparable results regarding safety and efficacy.

Equal Ratio Ventilation Reduces Blood Loss During Posterior Lumbar Interbody Fusion Surgery.

A prospective randomized double-blinded study. The aim of this study was to compare the effect of two different ventilator modes (inspiratory to expiratory ratio [I:E ratio] of 1:1 and 1:2) on intraoperative surgical bleeding in patients undergoing posterior lumbar interbody fusion (PLIF) surgery. During PLIF surgery, a considerable amount of blood loss is anticipated. In the prone position, engorgement of the vertebral vein increases surgical bleeding. We hypothesized that equal ratio ventilation (ERV) with I:E ratio of 1:1 would lower peak inspiratory pressure (PIP) in the prone position and consequentially decrease surgical bleeding. Twenty-eight patients were randomly assigned to receive either ERV (ERV group, n = 14) or conventional ventilation with I:E ratio of 1:2 (control group, n = 14). Hemodynamic and respiratory parameters were measured at 5 minutes after anesthesia induction, at 5 minutes after the prone position, at the time of skin closure, and at 5 minutes after turning to the supine position. The amount of intraoperative surgical bleeding in the ERV group was significantly less than that in the control group (975.7 ± 349.9 mL vs. 1757.1 ± 1172.7 mL, P = 0.030). Among other hemodynamic and respiratory parameters, PIP and plateau inspiratory pressure (Pplat) were significantly lower and dynamic lung compliance (Cdyn) was significantly higher in the ERV group than those of the control group throughout the study period, respectively (all P < 0.05). Compared to conventional ratio ventilation, ERV provided lower PIP and reduced intraoperative surgical blood loss in patients undergoing PLIF surgery.Level of Evidence: 2.

Distal tibial fractures: comparison between external locked plate and conventional open reduction and internal fixation

Background Distal tibial fractures are notorious for being associated with skin complications such as wound dehiscence and infection. The use of angle-stable external locked plate has a dual advantage, acting as an external fixator, which avoids the complications associated with conventional open surgery, and avoiding the cumbersome bulky external frames traditionally used for lower limb fractures. Moreover, joint spanning is not necessary in this technique, leaving the ankle joint free, avoiding joint stiffness commonly associated with the conventional frames. Patients and methods A total of 56 patients with closed distal tibial fractures were randomly assigned in two equal groups. Group A comprised patients treated with the conventional open reduction and internal fixation, whereas group B comprised patients treated with external locked plate (supracutaneous plate). The patients were assessed according to the Klemn and Borner scoring system at the end of follow-up. Results Group B patients had significantly better clinical and radiological outcome than group A. The union in group B was more rapid (12.96±2.74 weeks) than in group A (18.68±12.12 weeks), with a statistically significant difference between them. The rate of complications was significantly less in the group B, with only three patients having superficial self-limiting infection in comparison with group A, with 11 patients having deep infection and skin dehiscence with exposure of the plate. None of the cases of group B developed implant failure, whereas seven cases in group A developed implant failure. Conclusion Treatment of closed distal tibial fractures by external locked plate could result in a better functional outcome than conventional open reduction and internal fixation, while avoiding the skin complications associated with the conventional plating. Level of evidence Level II: prospective randomized double-blinded study.

An effect of 3-oxypyridine and succinic acid derivatives on the time of reduction of anxiety and depression symptoms in alcohol withdrawal treatment

To compare the effect of 3-oxypyridine and succinic acid derivatives (emoxypine, reamberin, mexidol) on the time of reduction of anxiety and depression symptoms in the standard treatment of alcohol withdrawal syndrome (AWS). A short-term prospective placebo-controlled double blind randomized study of the effect of emoxypine, reamberin, mexidol on the dynamics of reduction of anxiety and depression clinical symptoms in the course of a 14-day day hospital treatment of AWS was conducted. The severity of anxiety symptoms was assessed on a daily basis by using the Hamilton Anxiety Rating Scale (HARS). Symptoms of depression were assessed with the Montgomery-Asberg Depression Rating Scale (MADRS). Reduction of certain objective anxiety and depression symptoms was noticed at 0 point of the corresponding HARS and MADRS items. On the 1st and 14th day of treatment, the Zung Self-Rating Anxiety Scale (ZSRAS) and the Beck Depression Inventory (BDI) were additionally used. All the studied drugs reduced the duration of certain anxiety and depression symptoms during AWS treatment. The degree of this effect depended on the features of the chemical structure of a drug. Mexidol accelerated the reduction of «dread», «respiratory» and «cardiovascular» anxiety symptoms (HARS) by 25-50%. «Reduced appetite» and «concentration difficulty» (MADRS) improved by 28.5%. Reamberin reduced the duration of «gastrointestinal» and «respiratory» anxiety symptoms (HARS) by 17-50% and «inner tension» (MADRS) by 7%. Emoxypine accelerated the reduction of «insomnia» and «respiratory» symptoms (HARS) but did not affect the duration of objective depression symptoms (MADRS). Emoxypine and reamberin reduced the severity of affective and cognitive symptoms (BDI) by 32-37%. None of the drugs affected self-reported anxiety (ZSRAS). The most balanced treatment of depressive symptoms was provided by reamberin, which was the only of the studied drugs that simultaneously reduced both the duration of objective symptoms and the severity of subjective disorders of affective status in alcohol withdrawal.

Reinforcement of the abdominal wall with acellular dermal matrix or synthetic mesh after breast reconstruction with the pedicled transverse rectus abdominis musculocutaneous flap. A prospective double-blind randomized study

Introduction The pedicled transverse rectus abdominis musculocutaneous flap (p-TRAM) is a well-established option for autologous breast reconstruction (BR) but donor-site morbidity is still reported. The aim of the present study was to compare donor-site morbidity after reinforcement of the abdominal wall regarding development of bulging or hernia, abdominal muscle strength, complications, and abdominal pain hypothesizing, that reinforcement with acellular dermal matrix (Strattice™) is superior to reinforcement with synthetic mesh (Prolene®). Materials and methods A randomized, prospective, double-blind study was conducted with 29 patients admitted for BR with the p-TRAM flap at Department of Plastic Surgery, AUH, Denmark, 2014–2016. Allocation rate 1:1. Follow-up at 4, 12, and 24 months. Results 24 months postoperatively the computerized tomography verified bulging frequency was 35.7% in the ADM group and 6.7% in the synthetic mesh group (p = 0.11). Two patients (14.3%) in the ADM group and no patients in the synthetic mesh group developed hernia. No significant difference between baseline and 2-year measurement of abdominal muscle strength was observed. Conclusion The present study did not demonstrate any statistically significant differences between treatment groups regarding risk of bulging or hernia, abdominal muscle strength, complications, pain or pain related QoL within two years of follow-up. Although the small sample size sets limitations for drawing wide conclusions the hypothesis that reinforcement with ADM is superior to synthetic mesh cannot be confirmed. Further research into methods for decreasing donor-side morbidity related to the TRAM flap or other rectus abdominis muscle-based flaps is needed.

A prospective randomized double blind study to compare the effects of dexmedetomidine and fentanyl on intubating conditions during awake fiberoptic bronchoscopy guided intubation

A prospective randomized double blind study to compare the effects of dexmedetomidine and fentanyl on intubating conditions during awake fiberoptic bronchoscopy guided intubation - IJCA- Print ISSN No: - 2394-4781 Online ISSN No:- 2394-4994 Article DOI No:- 10.18231/2394-4994.2018.0078, Indian Journal of Clinical Anaes

Intraoperative clonidine vs lidocaine on hemodynamic response to laryngoscopic intubation and immune function in gynecological surgeries

BackgroundThis prospective randomised double-blind study was carried out on forty patients American Society of Anesthesiologists (ASA) physical status I–II , aged 40–60 years, scheduled for elective abdominal gynecological surgeries under general anesthesia after obtaining the approval of the local institutional ethical committee and oral consent of the patients. This study was conducted to evaluate the effects of perioperative intravenous clonidine versus lidocaine on hemodynamic stress response to laryngoscopic intubation, immune function, pain intensity, time to the first request for analgesia, and total dose of analgesic requirement in the first 24 h postoperatively in gynecological surgeries.ResultsThroughout the study, heart rate and mean arterial blood pressure were significantly lower in clonidine group (group C) compared to lidocaine group (group L). Postoperatively, the levels of IL-6 were significantly higher in (group L) compared to (group C). VAS pain scores were lower in the clonidine group in comparison to the lidocaine group. There was a higher total dose of analgesia in the lidocaine group when compared to the clonidine group.ConclusionsBoth clonidine and lidocaine can be used to attenuate the hemodynamic response; however, clonidine was better in the reduction of postoperative pain scores and the decrease in the production of pro-inflammatory cytokines.

Effect of 2% dextrose in ringer lactate on incidence of nausea and vomiting in laparoscopic cholecystectomy-Prospective randomized control study

Post-operative nausea and vomiting (PONV) is the distressing situation for patients &amp; caregivers. Various groups of pharmalogical agents are used for prophylaxis in high risk patients for PONV but they have their own advantage and disadvantages. Recent metaanalysis on intravenous use of 5% dextrose showed conflicting results with risk of hyperglycemis. So in this study we plan to use intravenous 2% dextrose in ringer lactate for prevention of PONV in laparoscopic cholecystectomy patients.This prospective randomized double-blind controlled study was conducted in 60 American Society of Anaesthesiologist 1 &amp; 11 patients, age 20-55 years undergoing elective laparoscopic cholecystectomy under general anaesthesia. Patients were randomly divided into two groups: group DRL received 2% dextrose in ringer lactate and group RL received ringer lactate. Allocate fluid was started at induction of anaesthesia and continued post-operatively up to 6hr. Incidence and severity of PONV was measured as a primary outcome. Secondary outcome includes comparison of blood sugar level, requirement of rescue antiemetic, time of oral acceptance of food &amp; time of discharge between two groups. Mean between two groups were compared with student t test. The critical value of ‘p’ indicating the probability of significant difference was taken as&amp;#60;0.05 for comparison.Incidence and severity of PONV was less in group DRL than group RL. Blood sugar level was higher in group DRL but within the normal range. Time of oral feed and time to discharge was early in group DRL.Intravenous 2% dextrose in ringer lactate reduces the incidence and severity of PONV in laparoscopic cholecystectomy patients.

Effects of Propofol, Dexmedetomidine, or Ketofol on Respiratory and Hemodynamic Profiles in Cardiac Patients Undergoing Transesophageal Echocardiography: A Prospective Randomized Study

The authors aimed to evaluate sedation characteristics, as well as cardiorespiratory effects, of propofol, dexmedetomidine, and ketofol used for conscious sedation during transesophageal echocardiography (TEE). Prospective double-blind randomized study. Tanta University hospitals. Seventy-five participants with left-to-right shunt requiring diagnostic TEE interventions. Patients were randomized into three groups-P, Dex, and K-to receive propofol, dexmedetomidine, or ketofol, respectively. Time to reach targeted sedation level, duration of the procedure, recovery time, hemodynamic parameters, incidence of oxygen desaturation <90%, as well as the cardiologist's satisfaction were recorded. The time onset and offset of sedation, duration of TEE procedure, and the need for rescue propofol were significantly less in the P and K groups compared with group Dex (p value 0.000*, 0.003*, 0.000*, and 0.000* and effect size 0.39, 0.15, 0.21, and 0.34, respectively). Mean arterial pressure, heart rate, and cardiac output significantly decreased in groups P and Dex compared with either baseline or group K. Hypoxic events were more manifest in group P; whereas group K had better cardiologist's satisfaction than the other two groups. In the TEE settings, the three agents were capable of attaining the targeted sedation levels , with propofol and ketofol having a faster onset and recovery times compared with dexmedetomidine. Even though dexmedetomidine and ketofol provided a more stable respiratory profile than propofol, ketofol was favorable in providing fewer hemodynamic alterations with better satisfaction scores than both propofol and dexmedetomidine.

Acute pain and side effects after tramadol in breast cancer patients: results of a prospective double-blind randomized study

The objective of this study was to evaluate the severity of acute pain and side effects in breast cancer patients postoperatively treated with two regimens of tramadol with paracetamol in a prospective double-blind study. Altogether 117 breast cancer patients who had axillary lymphadenectomy were randomized into two analgesic study groups and the analgesic treatment lasted 4 weeks. Stronger analgesia group received every 8 h 75/650 mg of tramadol with paracetamol, while weaker analgesia group received every 8 h 37.5/325 mg of tramadol with paracetamol. Patients with the higher dose of tramadol had less pain during the 1st and 4th week than patients with the lower dose. Frequency of nausea, vomiting, lymphedema or range of shoulder movement was not significantly different between the two groups of patients. Constipation was significantly more common in the group with stronger analgesia during the 2nd week in comparison to patients with weaker analgesia. The patients who were on 75/650 mg of tramadol with paracetamol had less pain in comparison to patients who were on 37.5/325 mg. Side effects were mild, but common in both groups of patients.

Analysis of low-dose estrogen on callus BMD as measured by pQCT in postmenopausal women

BackgroundOsteoporosis affects elderly patients of both sexes. It is characterized by an increased fracture risk due to defective remodeling of the bone microarchitecture. It affects in particular postmenopausal women due to their decreased levels of estrogen. Preclinical studies with animals demonstrated that loss of estrogen had a negative effect on bone healing and that increasing the estrogen level led to a better bone healing. We asked whether increasing the estrogen level in menopausal patients has a beneficial effect on bone mineral density (BMD) during callus formation after a bone fracture.MethodsTo investigate whether estrogen has a beneficial effect on callus BMD of postmenopausal patients, we performed a prospective double-blinded randomized study with 76 patients suffering from distal radius fractures. A total of 31 patients (71.13 years ±11.99) were treated with estrogen and 45 patients (75.62 years ±10.47) served as untreated controls. Calculated bone density as well as cortical bone density were determined by peripheral quantitative computed tomography (pQCT) prior to and 6 weeks after the surgery. Comparative measurements were performed at the fractured site and at the corresponding position of the non-fractured arm.ResultsWe found that unlike with preclinical models, bone fracture healing of human patients was not improved in response to estrogen treatment. Furthermore, we observed no dependence between age-dependent bone tissue loss and constant callus formation in the patients.ConclusionsTransdermally applied estrogen to postmenopausal women, which results in estrogen levels similar to the systemic level of premenopausal women, has no significant beneficial effect on callus BMD as measured by pQCT, as recently shown in preclinical animal models.Trial registrationLow dose estrogen has no significant effect on bone fracture healing measured by pQCT in postmenopausal women, DRKS00019858. Registered 25th November 2019 - Retrospectively registered. Trial registration number DRKS00019858.

Effects of throat packs during orthognathic surgery: a double-blind randomized controlled clinical trial

Throat packs are commonly used in maxillofacial surgeries. However, the evidence to support the benefits of their use is controversial. The aim of this study was to evaluate the effectiveness of throat packs in preventing postoperative nausea and vomiting, and their influence on the incidence of sore throat and dysphagia in patients undergoing orthognathic surgery. This was a prospective double-blind randomized study with 54 patients, who were randomized to two groups: with throat pack (n=27) and without throat pack (n=27). Fifty patients (25 in each group) were included in the analysis; 66% female and 34% male, mean age 29.44±8.53 years. Postoperative nausea and vomiting (Kortilla scale), sore throat (visual analogue scale), and dysphagia were evaluated. Statistically significant differences in favour of the without-pack group were found for the variables throat pain at 24hours (P=0.002) and dysphagia at 2 hours (P=0.007) and 24 hours (P<0.001). There was no difference between the groups regarding postoperative nausea and vomiting (P=1.00). The results of this study indicate that throat packs as utilized here do not prevent postoperative nausea and vomiting and are associated with worse sore throats and postoperative dysphagia.

Preoperative Fasting Abbreviation and its Effects on Postoperative Nausea and Vomiting Incidence in Gynecological Surgery Patients.

To investigate the effects of preoperative fasting abbreviation with a carbohydrate and protein-enriched solution, on postoperative nausea and vomiting (PONV) incidence in gynecological surgery patients, a population naturally at risk for such unpleasant episodes. The present prospective double-blind randomized study was performed at The Hospital Municipal e Maternidade Dr. Odelmo Leão Carneiro (HMMOLC, in the Portuguese acronym), in Uberlândia, state of Minas Gerais, Brazil, in partnership with the Gynecology Department of the Universidade Federal de São Paulo (UNIFESP), approved by the Human Research Ethics Committee of UNIFESP and the board of HMMOLC, and included in the Brazil Platform and in the Brazilian Clinical Trial Registry. After signing the consent form, 80 women, who were submitted to gynecological surgery in the period from January to June 2016, were randomized into 2 groups: control group (n = 42) and juice group (n = 38). They received, respectively, 200 mL of inert solution or liquid enriched with carbohydrate and protein 4 hours presurgery. The incidence, frequency and intensity of PONV were studied using the Visual Analogue Scale (VAS), with statistical analysis performed by the software IBM SPSS Statistics for Windows, Version 20.0 (IBM Corp, Armonk, NY, USA). The incidence of nausea and vomiting was lower than in the literature, to this population, with 18.9% (14/74) for the control group and 10.8% (8/74) for the juice group, respectively, with no statistically significant difference between the groups. The incidence of nausea and vomiting was lower than in the literature, but it cannot be said that this is due to the abbreviation of fasting. It can provide greater comfort, with the possibility of PONV prevention in patients at risk for these episodes.

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

The aim of this study was to compare the rate of chronic adverse effects after a weaker and stronger postoperative analgesia. A prospective double-blind randomized study included 117 breast cancer patients receiving tramadol for pain relief for 4weeks after an axillary lymphadenectomy from 2015 to 2018. Patients with a larger dose received 75/650mg of tramadol with paracetamol every 8h and a group with a lower dose received 37.5/325mg of tramadol with paracetamol every 8h from the 2nd to the 29th postoperative day. 1year after surgery, patients were evaluated for the presence of neuropathic pain, chronic pain, arm symptoms and lymphedema. There was a trend for a lower rate of neuropathic pain after stronger analgesia in comparison to weaker analgesia (p = 0.059). Chronic pain was present in 18% of patients 1year after the lymphadenectomy. There was no difference in the rate of chronic pain after stronger and weaker postoperative analgesia. Patients had less arm symptoms after a stronger analgesia than after a weaker analgesia (p = 0.02). Furthermore, there was a trend for a lower rate of lymphedema of the forearm after a stronger analgesia than after a lower analgesia (p = 0.078). The patients who received a stronger postoperative analgesia had less arm symptoms and a better quality of life in comparison to patients who received a weaker analgesia. The patients who received a stronger postoperative analgesia had a statistical trend for less neuropathic pain in comparison to patients who received a weaker analgesia.

Safety and efficacy of hypertonic saline solution (5%) versus placebo in the treatment of postoperative corneal edema after uneventful phacoemulsification: a randomized double-blind study.

To evaluate safety and efficacy of hypertonic saline solution administration after uneventful cataract surgery. Prospective double-blind randomized study METHODS: In total, 183 eyes of 183 patients undergoing phacoemulsification were randomly allocated into two equal groups. Treatment group (TG) subjects received single-dose hypertonic (NaCl 5%) solution 4 times daily for 14days, while placebo group (PG) received single dose of normal saline solution (0.9%) at the same frequency in addition to ordinary postoperative treatment. All patients underwent assessment of central corneal thickness (CCT), endothelial cell density (ECD), best-corrected visual acuity (BCVA), clinical staging of postoperative corneal edema and questionnaire regarding the procedure success and impact on patient's life. Measurements were taken at baseline and 1, 4, 9 and 30days following surgery. CCT increased by 134.67 ± 94.51μm (25.1 ± 19.4%) on postoperative day 1, without any difference between study groups (p = 0.58). Corneal edema showed a significant recession in TG compared to PG on day 4, in terms of both pachymetry (10.73% vs 7.39%, p = 0.004), BCVA (BCVATG = 0.64 ± 0.24 [logMARTG = 0.25 ± 0.3], BCVAPG = 0.56 ± 0.23 [logMARPG = 0.33 ± 0.3], p = 0.04) and clinical staging (p = 0.02). Similar results were recorded on postoperative day 9 in subjects demonstrating marked corneal edema on the first postoperative day. Endothelial cell loss showed no statistically significant difference between study groups (p = 0.48). No adverse events were recorded in relation to treatment. More patients in the TG (92.4% vs 57.1% in the PG) reported a subjectively clear vision 1week postoperatively (p = 0.04). The use of 5% hypertonic saline solution is found to be a safe and effective adjunct in the management of postoperative corneal edema after uneventful phacoemulsification, achieving rapid corneal clearance and expediting a good visual outcome, especially in cases with marked postoperative edema.

Intravenous Administration of Carbetocin Versus Oxytocin for Preventing Postpartum Hemorrhage After Vaginal Delivery in High Risk Women: A Double-blind, Randomized Controlled Trial

Abstract Objective: To compare the effects between carbetocin and oxytocin on reducing postpartum hemorrhage (PPH) after vaginal delivery in high risk pregnant women. Methods: A prospective double-blinded randomized study was conducted in the Nanjing Drum Tower Hospital from March to May 2018. Women at or beyond 28 gestational weeks, cephalic presentation, 18–45 years old, and with at least one risk factor for PPH, were enrolled. Using a computer-generated randomization sequence, women were randomized to carbetocin group or oxytocin group which receive 100 μg intravenous infusion carbetocin or 10 IU intravenous infusion of oxytocin after anterior shoulder and before placental delivery. The primary outcome was the incidence of blood loss ≥500 mL within 24 hours postpartum. The secondary outcomes were amount of total blood loss, blood loss within 2 hours after delivery, the rate of blood loss ≥ 1 000 mL postpartum, need for a second-line uterotonics and interventions, blood transfusion, difference between hemoglobin before and 48 hours after delivery, adverse maternal events attributed to the trial medication. Hemodynamic status (blood pressure and pulse) was measured at 0 minutes, 30 minutes, 60 minutes, and 120 minutes after delivery. Results: A total of 314 and 310 participants constituted the carbetocin and oxytocin groups, respectively. The baseline characteristics were comparable between the groups. The carbetocin group had similar rates of PPH (blood loss ≥500 mL) and rates of ≥1 000 mL PPH, (29.6% vs. 26.8%, P = 0.48) and (3.2% vs. 3.5%, P = 0.83), to the oxytocin group. The average amount of bleeding was (422.9 ± 241.4) mL in carbetocin group and (406.0 ± 257.5) mL in oxytocin group, which was no statistically significant difference (P = 0.40). Either the amount of blood loss within 2 hours ((55.5 ± 33.9) mL vs. (59.9 ± 48.7) mL) was no statistically significant difference (P = 0.19). The need for therapeutic uterotonics was 23.9% in carbetocin group and 23.5% in oxytocin group, which was also no statistically difference (P = 0.93). The rate of blood transfusion (P = 0.62) and hemoglobin change (P = 0.07) were not differ between the carbetocin and oxytocin groups. However, the rate of manually removing placenta was significantly different between two groups regarding the need for manually remove of placenta because of uterine bleeding in the third stage of labor (4 cases in carbetocin group vs. 13 cases in oxygen group), especially in those after oxytocin-induced or augmented labor (relative risk:3.39, 95% confidence interval: 1.09–10.52). After delivery, the blood pressure in the carbetocin group tend to be lower than that in the oxytocin group (P &gt; 0.05), especially at 30 minutes postpartum (P &lt; 0.05), while pulse tend to be simultaneously higher (P &gt; 0.05). Conclusion: Among women with high risk of PPH, intravenous carbetocin infusion did not better than oxytocin in the prevention of blood loss ≥500 mL after vaginal delivery.

Radiofrequency Treatment of Labia Minora and Majora: A Minimally Invasive Approach to Vulva Restoration.

Summary:Labiaplasty has rapidly increased in popularity over the past 5 years.Traditional labiaplasty is associated with potential complications, such as dehiscence, hematoma, flap necrosis, narrowed introitus, pain, and asymmetry. Minimally invasive techniques such as radiofrequency (RF) have emerged as viable alternatives to traditional labiaplasty through a temperature-controlled bipolar mechanism to heat tissues to target temperatures of 40°C–45°C. This controlled energy delivery leads to an inflammatory cascade initiating neocollagenesis, angiogenesis, and elastogenesis over the coming 3–4 months. A single surgeon series of labia minora and majora treatment by RF (InMode, Lake Forrest, Calif.) was reviewed between April 2018–October 2018. Demographic data were collected as well grade of hypertrophy (pre/posttreatment), number of vaginal deliveries, and reason for treatment. Procedural parameters were recorded, including internal/external temperatures, total energy used, and time of treatment. All adverse events were recorded. Objective and subjective data points were obtained in the form of patient surveys and photographic evaluation by lay persons as well as plastic surgeons objective to the treatment. Ten consecutive patients were treated with bipolar RF (InMode, Lake Forrest, Calif.) between April 2018–October 2018. Mean age was 44 (29–54). Average number of pregnancies was 2 (STD 1.1). Three patients were treated for aesthetic concerns, 3 for functional complaints, and 4 desired improvement in both. Overall graded improvement in labia size/contour was +50% (STD ±15.3). Patient satisfaction scale data demonstrated 9.5/10 (±1.7). All patients (10/10) stated that they would undergo treatment again. In all cases, the surgeon observed tightening of the clitoral hood, introitus, forchett, as well as improved distribution of dark pigmentation of the labia minora. There were no significant complications and no need for additional procedures. Average recovery time was 14 days (STD 2.2). Treatment of labia hyperplasia and laxity with bipolar RF may potentially fill a treatment gap of women seeking aesthetic and functional improvements without surgical labiaplasty. A powered prospective randomized double-blinded study is needed to further elucidate the role of this technology.