Preoperative Administration of Extended-Release Dinalbuphine Sebacate Compares with Morphine for Post-Laparoscopic Cholecystectomy Pain Management: A Randomized Study.
ABSTRACT: Purpose:Perioperative pain management plays a critical role in the effort to promote enhanced recovery after surgery (ERAS). Pain is also the most concern for patients after laparoscopic cholecystectomy (LC). Naldebain (extended-release dinalbuphine sebacate, DS) is an oil-based formulation for intramuscular injection that has been designed for extended release and can be used for preoperative analgesia over a 7-day period. This study was aimed to compare the efficacy of DS injection with that of regular postoperative morphine administered when necessary for the management of post-laparoscopic cholecystectomy pain. Patients and Methods:Forty-four patients scheduled for elective laparoscopic cholecystectomy were included in this prospective study. The patients were allocated randomly into two groups, with equal numbers receiving preoperative DS versus post-operative morphine. A total of 21 and 22 patients completed the study within the preoperative DS and post-operative morphine group, respectively. Results:There were no statistically significant differences between two treatment groups with respect to length of surgery, anesthetics used during operation, or the average visual analog scale pain score in the post-operative anesthesia care unit (PACU), and at 4, 24, 48, and 72 hours post-procedure. Morphine was required only during the first postoperative day among those in the DS group. Safety was comparable in both DS and morphine groups. Conclusion:A single preoperative dose of DS provides sufficient analgesia along with a manageable safety profile and no interference with surgical anesthetics when compared to control cases that underwent surgery without preoperative DS treatment. This pilot study suggests that preoperative administration of DS is safe and may decrease the need for postoperative opioid use after laparoscopic cholecystectomy. Registration:ClinicalTrials.gov Identifier: NCT03713216.
Project description:Single-incision laparoscopic surgery also known as laparo-endoscopic single-site surgery for cholecystectomy is performed using a single umbilical skin incision through which a laparoscope and two instruments are introduced. It is virtually a "scarless" surgery. The present study was undertaken to evaluate the efficacy of single-incision laparoscopic cholecystectomy using conventional instruments and compare it with three-port laparoscopic cholecystectomy. Thirty patients who underwent single-incision cholecystectomy were compared to an equal number of patients who underwent three-port cholecystectomy. Both groups were assessed on the basis of operative time, intraoperative complications, postoperative pain, ambulation, hospital stay, and body image at first and third week. Single-incision cholecystectomy had the advantage of less postoperative pain, early ambulation, and better body image as compared to three-port cholecystectomy; the results being statistically significant. There was no statistically significant difference in operative time and hospital stay between the two groups. Single-incision laparoscopic cholecystectomy using conventional instruments is a safe and effective surgery. It gives better cosmetic results, almost scarless surgery, without increasing the cost of surgery.
Project description:Female gender has been identified as one of the risk factors closely linked to perioperative anxiety and a lower level of satisfaction. A successful preoperative anesthesia education may improve such negative outcomes. The aim of this study was to investigate whether preoperative anesthesia education via an Anesthesia Service Platform (ASP) could reduce the anxiety levels in female patients scheduled for laparoscopic cholecystectomy under general anesthesia, and accelerate rehabilitation. A total of 222 patients scheduled for elective laparoscopic cholecystectomy were randomly assigned to the control group and the ASP group. Patients' baseline and post-intervention psychological status was measured by the State-Trait Anxiety Inventory and General Well-Being Schedule. Pain management and recovery were assessed by VAS every 12 h for 48 h after surgery; length of stay (LOS) and postoperative analgesic consumption were also assessed. Patients in the control group experienced higher anxiety levels before surgery and had longer LOS than those in the ASP group. Patients in the ASP group had a higher general well-being score; however, they suffered more pain and consumed more analgesics after surgery. ASP is effective for preventing anxiety in female patients before laparoscopic cholecystectomy, improving patients' general well-being levels, and shortening their LOS, but negatively influences patients' postoperative pain levels.
Project description:Background. Intraperitoneal nebulization of ropivacaine reduces postoperative pain and morphine consumption after laparoscopic surgery. The aim of this multicenter double-blind randomized controlled trial was to assess the efficacy of different doses and dose-related absorption of ropivacaine when nebulized in the peritoneal cavity during laparoscopic cholecystectomy. Methods. Patients were randomized to receive 50, 100, or 150?mg of ropivacaine 1% by peritoneal nebulization through a nebulizer. Morphine consumption, pain intensity in the abdomen, wound and shoulder, time to unassisted ambulation, discharge time, and adverse effects were collected during the first 48 hours after surgery. The pharmacokinetics of ropivacaine was evaluated using high performance liquid chromatography. Results. Nebulization of 50?mg of ropivacaine had the same effect of 100 or 150?mg in terms of postoperative morphine consumption, shoulder pain, postoperative nausea and vomiting, activity resumption, and hospital discharge timing (>0.05). Plasma concentrations did not reach toxic levels in any patient, and no significant differences were observed between groups (P > 0.05). Conclusions. There is no enhancement in analgesic efficacy with higher doses of nebulized ropivacaine during laparoscopic cholecystectomy. When administered with a microvibration-based aerosol humidification system, the pharmacokinetics of ropivacaine is constant and maintains an adequate safety profile for each dosage tested.
Project description:BACKGROUND:As a part of multimodal analgesia for laparoscopic cholecystectomy, both intraoperative lidocaine and esmolol facilitate postoperative analgesia. Our objective was to compare these two emerging strategies that challenge the use of intraoperative opioids. We aimed to assess if intraoperative esmolol infusion is not inferior to lidocaine infusion for opioid consumption after laparoscopic cholecystectomy. METHODS:In this prospective, randomized, double-blind, non-inferiority clinical trial, 90 female patients scheduled for elective laparoscopic cholecystectomy received either intravenous (IV) lidocaine bolus 1.5?mg/kg at induction followed by an infusion (1.5?mg/ kg/h) or IV bolus of esmolol 0.5?mg/kg at induction followed by an infusion (5-15??g/kg/min) till the end of surgery. Remaining aspect of anesthesia followed a standard protocol apart from no intraoperative opioid supplementation. Postoperatively, patients received either morphine or tramadol IV to maintain visual analogue scale (VAS) scores ?3. The primary outcome was opioid consumption (in morphine equivalents) during the first 24 postoperative hours. Pain and sedation scores, time to first perception of pain and void, and occurrence of nausea/vomiting were secondary outcomes measured up to 24?h postoperatively. RESULTS:Two patients in each group were excluded from the analysis. The postoperative median (IQR) morphine equivalent consumption in patients receiving esmolol was 1 (0-1.5) mg compared to 1.5 (1-2) mg in lidocaine group (p?=?0.27). The median pain scores at various time points were similar between the two groups (p?>?0.05). More patients receiving lidocaine were sedated in the post-anesthesia care unit (PACU) than those receiving esmolol (p?<?0.05); however, no difference was detected later. CONCLUSION:Infusion of esmolol is not inferior to lidocaine in terms of opioid requirement and pain severity in the first 24?h after surgery. Patients receiving lidocaine were more sedated during their stay in PACU than those receiving esmolol. TRIAL REGISTRATION:ClinicalTrials.gov - NCT02327923. Date of registration: December 31, 2014.
Project description:<h4>Background and objective</h4>We conducted a network meta analysis (NMA) to compare different kinds of laparoscopic cholecystectomy [LC] (single port [SPLC], two ports [2PLC], three ports [3PLC], and four ports laparoscopic cholecystectomy [4PLC], and four ports mini-laparoscopic cholecystectomy [mini-4PLC]).<h4>Methods</h4>PubMed, the Cochrane library, EMBASE, and ISI Web of Knowledge were searched to find randomized controlled trials [RCTs]. Direct pair-wise meta analysis (DMA), indirect treatment comparison meta analysis (ITC) and NMA were conducted to compare different kinds of LC.<h4>Results</h4>We included 43 RCTs. The risk of bias of included studies was high. DMA showed that SPLC was associated with more postoperative complications, longer operative time, and higher cosmetic score than 4PLC, longer operative time and higher cosmetic score than 3PLC, more postoperative complications than mini-4PLC. Mini-4PLC was associated with longer operative time than 4PLC. ITC showed that 3PLC was associated with shorter operative time than mini-4PLC, and lower postoperative pain level than 2PLC. 2PLC was associated with fewer postoperative complications and longer hospital stay than SPLC. NMA showed that SPLC was associated with more postoperative complications than mini-4PLC, and longer operative time than 4PLC.<h4>Conclusion</h4>The rank probability plot suggested 4PLC might be the worst due to the highest level of postoperative pain, longest hospital stay, and lowest level of cosmetic score. The best one might be mini-4PLC because of highest level of cosmetic score, and fewest postoperative complications, or SPLC because of lowest level of postoperative pain and shortest hospital stay. But more studies are needed to determine which will be better between mini-4PLC and SPLC.
Project description:Aim. A double-blind, randomized, placebo-controlled trial was designed to evaluate the efficacy of continuous intraoperative infusion of S(+)-ketamine under intravenous anesthesia with target-controlled infusion of remifentanil and propofol for postoperative pain control. Methods. Forty-eight patients undergoing laparoscopic cholecystectomy were assigned to receive continuous S(+)-ketamine infusion at a rate of 0.3?mg·kg(-1)·h(-1) (n = 24, intervention group) or an equivalent volume of saline at the same rate (n = 24, placebo group). The same target-controlled intravenous anesthesia was induced in both groups. Pain was assessed using a 0 to 10 verbal numeric rating scale during the first 12 postoperative hours. Pain scores and morphine consumption were recorded in the postanesthesia care unit (PACU) and at 4 and 12 hours after surgery. Results. Pain scores were lower in the intervention group at all time points. Morphine consumption did not differ significantly between groups during PACU stay, but it was significantly lower in the intervention group at each time point after PACU discharge (P = 0.0061). At 12 hours after surgery, cumulative morphine consumption was also lower in the intervention group (5.200 ± 2.707) than in the placebo group (7.525 ± 1.872). Conclusions. Continuous S(+)-ketamine infusion during laparoscopic cholecystectomy under target-controlled intravenous anesthesia provided better postoperative pain control than placebo, reducing morphine requirement. Trial Registration. This trial is registered with ClinicalTrials.gov NCT02421913.
Project description:BACKGROUND:Previous studies have reported that same-day laparoscopic cholecystectomy for acute cholecystitis is superior to delayed elective cholecystectomy. Although this practice is ideal, it requires significant hospital resources, particularly for an underprivileged inner-city population at a large, municipal hospital. We sought to evaluate the implementation of same-day laparoscopic cholecystectomy in a large, municipal hospital and assess the possible benefits of decreasing preoperative length of stay (LOS), particularly its effect on operative time and length of stay in patients with acute cholecystitis. MATERIALS AND METHODS:This was a retrospective chart review of patients treated for symptomatic gallstone disease between September 2012 and November 2013. Medical records were reviewed, and relevant data points were collected. Univariate and multivariate regressions were performed to assess the correlation between time to operation (<36 h [no delay] or >36 h [delay]) and the main outcomes (operative time and total length of stay). Inclusion criteria were patients age ?18 y who underwent same-admission cholecystectomy and had a diagnosis of cholecystitis on pathology. Eighty-eight patients met all inclusion criteria. RESULTS:The mean (standard deviation) preoperative LOS was 76.2 (±48.6) h, the mean operative time was 2.3 (±1.1) h, and the mean postoperative LOS was 60.3 (±60.1) h. The average total LOS was 136 (±79.8) h. Operative times and postoperative LOS were similar for patients in the delay and no delay groups. Patients with >36 h wait before surgery had a total length of stay twice as long as patients with <36 h wait (152 versus 83.3 h; P = 0.0005). These findings remained significant when adjusted for age, sex, radiologic findings, number of preoperative tests, and pathology. CONCLUSIONS:Increased preoperative LOS is not associated with a significant increase in operative time. However, it was associated with significantly increased length of stay. Further analysis is needed to explore the potential cost savings of decreasing preoperative LOS.
Project description:Introduction:Gabapentinoids are increasingly used in preoperative premedication despite controversial results. The aim of our study was to evaluate the effects of preemptive use of gabapentin or pregabalin on postoperative shoulder pain and rehabilitation quality after laparoscopic cholecystectomy. Methods:This is a clinical trial comparing the effects of a preoperative premedication with 600?mg of gabapentin or 150?mg of pregabalin versus placebo on postoperative pain and recovery quality after laparoscopic cholecystectomy. Premedication was taken 2 hours before the surgery beginning. Ninety patients were included and randomized into 3 groups (gabapentin, pregabalin, and placebo). The anesthetic protocol was the same for all patients. Primary endpoint was the shoulder pain intensity at the 48th postoperative hour. Secondary endpoints were postoperative nausea and vomiting (PONV), sleep quality during the first night, and the onset time for the first standing position. Results:During the first 48 postoperative hours, the gabapentin and pregabalin groups had significantly lower shoulder pain than the placebo group (p < 0.05). In gabapentinoids groups, the incidence of PONV was lower and the sleep quality during the first postoperative night was better with significant results. Mean Spiegel scores were 22.43?±?1.45, 22.30?±?1.44, and 17.17?±?1.66, respectively, in pregabalin, gabapentin, and placebo groups (p < 0.05). The delay for the first standing position was 14.9?±?4.9 hours in the pregabalin group, 9.7?±?3.6 hours in the gabapentin group, and 21.6?±?2.1 hours in the placebo group. No superiority was found between gabapentin and pregabalin. Conclusion:Preemptive premedication with gabapentinoids can enhance postoperative rehabilitation quality after laparoscopic cholecystectomy by reducing postoperative shoulder pain, decreasing PONV incidence, and improving sleep quality during the first postoperative night. This trial is registered with ClinicalTrial.gov (NCT03241875).
Project description:Background:The ultrasound (US)-guided erector spinae plane (ESP) block and oblique subcostal transversus abdominis plane (OSTAP) block are used to decrease postoperative pain and subsequently opioids consumption. Aim:The aim was to test the hypothesis that US-guided ESP blocks can produce more reduction in opioid usage during the first 24 h after laparoscopic cholecystectomy when compared to OSTAP block. Settings and Design:Seventy adult patients (20-60 years old) who were planned to undergo elective laparoscopic cholecystectomy were allocated in three groups in randomized controlled trial. Materials and Methods:The three groups received either port site infiltration, US-guided bilateral ESP block (ESP group), or OSTAP (OSTAP group) with bupivacaine hydrochloride 0.25%. Statistical Analysis:Postoperative 24 h Morphine consumption, visual analogue scale (VAS), the intraoperative fentanyl (?g) and equivalent morphine dose in the recovery unit were recorded and analyzed using one-way analysis of variance. Results:The mean 24-h morphine consumption was statistically significant between groups (P < 0.001), but it was insignificant between ESP and OSTAP (P = 0.173). Median (range) and interquartile range of intraoperatively consumed fentanyl showed significance between the three groups (P < 0.001). There was insignificance between ESP block Group II and OSTAP block Group III (P = 0.95) by post hoc analysis. The mean values of VAS at both rest and movement of the control group were significantly higher than the ESP block group at 6 and 12 h postoperative. Conclusion:Bilateral US-guided ESP block was found to be as effective as bilateral US OSTAP block. There was more decrease in intraoperative rescue fentanyl, PACU morphine analgesia, 24-h morphine, and pain assessment score in both groups than the control port-site infiltration group.Clinical trial registration number: NCT03398564.
Project description:Several techniques are used for surgical treatment of gallstone disease with biliary duct calculi, but the safety and efficacy of these approaches have not been compared.To compare the efficacy and safety of 4 surgical approaches to gallstone disease with biliary duct calculi.MEDLINE, Scopus, and ISI-Web of Science databases, articles published between 1950 and 2017 and searched from August 12, 2017, to September 14, 2017. Search terms used were LCBDE, LC, preoperative, ERCP, postoperative, period, cholangiopancreatography, endoscopic, retrograde, rendezvous, intraoperative, one-stage, two-stage, single-stage, gallstone, gallstones, calculi, stone, therapy, treatment, therapeutics, surgery, surgical, procedures, clinical trials as topic, random, and allocation in several logical combinations.Randomized clinical trials comparing at least 2 of the following strategies: preoperative endoscopic retrograde cholangiopancreatography (PreERCP) plus laparoscopic cholecystectomy (LC); LC with laparoscopic common bile duct exploration (LCDBE); LC plus intraoperative endoscopic retrograde cholangiopancreatography (IntraERCP); and LC plus postoperative ERCP (PostERCP).A frequentist random-effects network meta-analysis was performed. The surface under the cumulative ranking curve (SUCRA) was used to show the probability that each approach would be the best for each outcome.Primary outcomes were the safety to efficacy ratio using overall mortality and morbidity rates as the main indicators of safety and the success rate as an indicator of efficacy. Secondary outcomes were acute pancreatitis, biliary leak, overall bleeding, operative time, length of hospital stay, total cost, and readmission rate.The 20 trials comprised 2489 patients (and 2489 procedures). Laparoscopic cholecystectomy plus IntraERCP had the highest probability of being the most successful (SUCRA, 87.2%) and safest (SUCRA, 69.7%) with respect to morbidity. All approaches had similar results regarding overall mortality. Laparoscopic cholecystectomy plus LCBDE was the most successful for avoiding overall bleeding (SUCRA, 83.3%) and for the shortest operative time (SUCRA, 90.2%) and least total cost (SUCRA, 98.9%). Laparoscopic cholecystectomy plus IntraERCP was the best approach for length of hospital stay (SUCRA, 92.7%). Inconsistency was found in operative time (indirect estimate, 19.05; 95% CI, 2.44-35.66; P = .02) and total cost (indirect estimate, 17.06; 95% CI, 3.56-107.21; P = .04). Heterogeneity was observed for success rate (τ, 0.8), operative time (τ, >1), length of stay (τ, >1), and total cost (τ, >1).The combined LC and IntraERCP approach had the greatest odds to be the safest and appears to be the most successful. Laparoscopic cholecystectomy plus LBCDE appears to reduce the risk of acute pancreatitis but may be associated with a higher risk of biliary leak.