Liposomal bupivacaine infiltration at the surgical site for the management of postoperative pain.
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ABSTRACT:
SUBMITTER: Hamilton TW
PROVIDER: S-EPMC6464293 | biostudies-literature |
REPOSITORIES: biostudies-literature
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| S-EPMC6457974 | biostudies-literature
Project description:Liposomal bupivacaine (LB) has consistently been considered a potential analgesic for surgical wound infiltration. However, the evidence of its analgesic effectiveness remains unclear. In this meta-analysis, we attempted to identify the potential clinical role of LB wound infiltration in different surgical procedures. Randomised controlled trials (RCTs) comparing LB with non-liposomal local anaesthetics and placebos were retrieved from six electronic databases. The primary outcome was cumulative morphine equivalent consumption within 24, 48, and 72 hours after surgery. Approximately 2659 patients from 22 studies were included in the meta-analysis. Compared to the control, LB-wound infiltration did not reduce the postoperative morphine consumption at 24 hours (weighted mean difference [WMD], -0.60 mg; 97.5% confidence interval [CI], -2.78 to 1.59 mg; P = 0.54), 48 hours (WMD, -1.00 mg; 97.5% CI, -3.23 to 1.24; P = 0.32) or 72 hours (WMD, 0.50 mg; 97.5% CI, -0.67 to 1.67; P = 0.33). Similarly, secondary outcome analysis did not reveal any additional benefits of LB in any other pain-related outcomes. LB was not associated with any adverse effects. Overall, LB does not appear to improve the postoperative analgesic, rehabilitation, or safety outcomes. Current evidence does not support the routine use of LB for wound infiltration following surgical procedures.
| S-EPMC10088822 | biostudies-literature
Project description:ImportanceLiposomal bupivacaine for pain relief is purported to last 3 days compared with 8 hours with standard bupivacaine. However, its effectiveness is unknown in truncal incisions for cardiothoracic or vascular operations.ObjectiveTo compare the effectiveness of single-administration standard bupivacaine vs liposomal bupivacaine in patients undergoing truncal incisions.Design, setting, and participantsThis randomized clinical trial enrolled patients undergoing sternotomy, thoracotomy, minithoracotomy, and laparotomy from a single cardiovascular surgery department in an academic medical center between November 2012 and June 2018. The study was powered to detect a Cohen effect size of 0.35 with a power of greater than 80%. Data analysis was performed from July to December 2018.InterventionPatients were randomized to standard bupivacaine or liposomal bupivacaine.Main outcomes and measuresPain was assessed over 3 postoperative days by the Numeric Rating Scale (NRS). Adjunctive opioids were converted to morphine equivalents units (MEU). NRS scores were compared using Wilcoxon rank-sum (3-day area under the curve) and 2-way nonparametric mixed models (daily scale score) to assess time-by-group interaction. Secondary outcomes included cumulative opioid consumption.ResultsA total of 280 patients were analyzed, with 140 in each group (single-administration standard bupivacaine vs liposomal bupivacaine). Mean (SD) age was 60.2 (14.4) years, and 101 of 280 patients (36%) were women. Irrespective of treatment assignment, pain decreased by a mean of approximately 1 point per day over 3 days (β = -0.87; SE = 0.11; mixed model regression P < .001). Incision type was associated with pain with patients undergoing thoracotomy (including minithoracotomy) reporting highest median (interquartile range [IQR]) pain scores on postoperative days 1 (liposomal vs standard bupivacaine, 6 [4-8] vs 5 [3-7]; P = .049, Wilcoxon rank-sum) and 2 (liposomal vs standard bupivacaine, 5 [4-7] vs 4 [2-6]; P = .003, Wilcoxon rank-sum) but not day 3 (liposomal vs standard bupivacaine, 3 [2-6] vs 3 [1-5]; P = .10, Wilcoxon rank-sum), irrespective of treatment group. Median (IQR) 3-day cumulative NRS was 12.0 (8.0-16.5) for bupivacaine and 13.5 (9.0-17.0) for liposomal bupivacaine (P = .15, Wilcoxon rank-sum) Furthermore, use of opioids was greater following liposomal bupivacaine compared with standard bupivacaine (median [IQR], 41.5 [21.3-73.8] MEU vs 33.0 [17.8-62.5] MEU; P = .03, Wilcoxon rank-sum). On multivariable analysis, no interaction by incision type was observed for mean pain scores or opioid use.Conclusions and relevanceIn this randomized clinical trial involving truncal incisions for cardiovascular procedures, liposomal bupivacaine did not provide improved pain control and did not reduce adjunctive opioid use compared with conventional bupivacaine formulation over 3 postoperative days.Trial registrationClinicalTrials.gov Identifier: NCT02111746.
| S-EPMC7967071 | biostudies-literature
Project description:Patients undergoing total knee arthroplasty (TKA) report low satisfaction with postoperative pain control. The purpose of this study is to examine if there is a difference in post-operative pain for TKA patients without femoral nerve block receiving an intra-operative pericapsular injection of bupivacaine liposome suspension (EXPAREL; Pacira Pharmaceuticals, Inc., San Diego, California) versus a concentrated multi drug cocktail. Seventy TKA patients were randomly assigned to either the bupivacaine liposome or the multi-drug cocktail. Post-operative pain scores, morphine sulfate equivalence consumption values, adverse events, and overall pain control satisfaction scores were collected. Patients reported significantly higher pain level for the cocktail group on post-op day 1 (p < .05) and post-op day 2 (p < .01) versus the bupivacaine liposome group. This same trend was found for morphine sulfate equivalence consumption in the PACU (p < .01) and post-op day 2 (p < .01). Higher satisfaction in pain control (p < .001) and overall experience (p < .01) was also found in the bupivacaine liposome group. Finally, significantly more adverse events were found in the multi-drug group versus the bupivacaine liposome group (p < .05). The study findings demonstrated a non-inferior difference, albeit not a clinically significant difference, in patient-perceived pain scores, morphine sulfate equivalence consumption, adverse events, and overall satisfaction.
| S-EPMC4957154 | biostudies-literature
Project description:BackgroundUpper extremity surgery is commonly performed in the ambulatory setting and is associated with moderate to severe postoperative pain.MethodsPatients scheduled for upper extremity orthopedic surgery with a peripheral nerve block were randomized to receive either an ultrasound-guided single-injection supraclavicular block or ultrasound-guided median, ulnar, and radial nerve blocks (forearm blocks) performed at the level of the mid to proximal forearm with liposomal bupivacaine (Exparel) combined with a short-acting supraclavicular block. A sham block was performed in an attempt to blind enrollees in the control group. We administered the EuroQol 5D-5L questionnaire preoperatively and on postoperative days 1-3 and considered the results the primary outcome of our investigation. Block procedure times, postanesthesia care unit (PACU) length of stay, instances of nausea/vomiting, need for narcotic administration, and patient satisfaction were also assessed.ResultsWe observed no significant differences in postoperative EuroQol scores between the 2 groups and no significant differences in patient demographics, PACU length of stay, or side effects in the PACU. In some instances, the short-acting supraclavicular block resolved in the PACU, and these patients reported higher pain scores and required titration of analgesics prior to discharge.ConclusionLarger prospective studies are needed to determine the safety and efficacy of liposomal bupivacaine in patients undergoing upper extremity surgery. Liposomal bupivacaine is currently only approved for local anesthetic infiltration use.
| S-EPMC5158147 | biostudies-literature
Project description:Spinal deformity corrections in paediatric patients are long-lasting procedures involving damage to many tissues and long pain exposure; therefore, effective pain management after surgical treatment is an important issue. In this study, the effect of inclusion of local infiltration analgesia, as an integral part of the scheme in postoperative pain control, in children and adolescents, subjected to the spinal deformity correction procedure, was assessed. Thirty patients, aged 8 to 17 years, undergoing spinal deformity correction were divided into a study group, receiving a 0.25% bupivacaine solution before wound closure, and a control group (no local analgesic agent). Morphine, at the doses of 0.10 mg/kg of body weight, was administered to the patients when pain occurred. Pain scores, morphine administration, and bleeding were observed during 48 postoperative hours. The pain scores were slightly lower in a 0-4 h period in patients who received bupivacaine compared with those in the control group. However, no differences were observed in a longer period of time and in the total opioid consumption. Moreover, increasing bleeding was observed in the bupivacaine-treated patients (study group) vs. the control. Bupivacaine only modestly affects analgesia and, due to the increased bleeding observed, it should not to be part of pain control management in young patients after spinal deformity correction.
| S-EPMC8198662 | biostudies-literature
Project description:ImportanceMost women report moderate to severe pain after cesarean delivery. The extent of the ability of surgical wound infiltration with local anesthetic agents during cesarean delivery for the reduction of postoperative pain is uncertain.ObjectiveTo examine the efficacy of single wound infiltration with bupivacaine and adrenaline during cesarean delivery for the reduction of postoperative pain.Design, setting, and participantsThis randomized clinical trial was conducted between January 25, 2018, and May 30, 2020, at a university teaching hospital in Afula, Israel. A total of 288 women with singleton pregnancy who were scheduled for a planned cesarean delivery at term were randomized to receive single wound infiltration with bupivacaine and adrenaline during cesarean delivery (intervention group) or no single wound infiltration (control group) at a 1:1 ratio.InterventionsIn the intervention group, the subcutaneous layer was infiltrated on both sides of the wound by a mixture of bupivacaine and adrenaline before wound closure. Other perioperative techniques were similar between the groups.Main outcomes and measuresThe primary outcome was mean pain intensity over the course of 24 hours after the operation, as measured by a visual analog scale (VAS) score ranging from 0 to 10 (with higher scores indicating greater pain intensity). To detect a mean (SD) reduction of 1 (3) points in the VAS score in the intervention group, 286 women were needed in total. Secondary outcomes included VAS score greater than 4 (indicating moderate pain) at 2 hours after the operation, use of rescue opioids, maternal satisfaction with the pain management procedure (using a scale of 1-5, with higher scores indicating greater satisfaction), duration of the operation, scar complications (hematoma, infection, and separation), and length of stay.ResultsAmong 288 women (mean [SD] age, 32.5 [5.1] years; all of Arab or Jewish ethnicity), 143 were randomized to the intervention group, and 145 were randomized to the control group. Demographic and obstetric variables were similar between groups. The primary outcome (VAS pain score) was significantly lower in the intervention group (mean [SD], 2.21 [0.56]) compared with the control group (mean [SD], 2.41 [0.73]; P = .02). In the intervention group, 11 women (7.7%) had a VAS score greater than 4 at 2 hours compared with 22 women (15.2%) in the control group (odds ratio, 0.47; 95% CI, 0.22-1.00; P = .05). In addition, compared with the control group, the intervention group had significantly lower postpartum use of rescue opioid analgesics (19 women [13.3%] vs 37 women [25.5%]; P = .009) and greater satisfaction with pain management (mean [SD] score, 4.65 [0.68] vs 4.44 [0.76]; P = .007). In the intervention vs control groups, duration of the operation, scar complications (hematoma, infection, or separation), and length of stay were comparable.Conclusions and relevanceIn this study, wound infiltration with a single administration of bupivacaine and adrenaline during cesarean delivery reduced postoperative pain and opioid use and may have improved maternal satisfaction with pain management. These findings suggest the technique is efficacious, safe, and easy to perform.Trial registrationClinicalTrials.gov Identifier: NCT03395912.
| S-EPMC9667325 | biostudies-literature
Project description:BackgroundLiposomal bupivacaine (LB) is approved by the U.S. Food and Drug Administration for administration into surgical sites for postsurgical analgesia. The liposomal formulation allows for sustained effects up to 72 hours.MethodsA retrospective study assessed patients undergoing lumbar interbody surgery. Visual analog scale pain scores and amount of opioids consumed were recorded at 12-hour intervals for 72 hours postoperatively, as were patterns of discharge and hospital length of stay (LOS).ResultsA total of 122 patients (97 LB vs. 25 control group) were reviewed. Median LOS was shorter in the LB cohort compared with controls (1.94 vs. 3.08 days, respectively; P = 0.0043). When assessing the percentage of discharges between groups at 12-hour intervals, there were significantly more discharges in the LB cohort at 36-48 hours (P = 0.0226), and no differences elsewhere. There was a decrease in intravenous opioids consumed at 48-60 hours in the LB cohort compared with controls (P = 0.0494), a difference not detected at other time points or with oral or total opioids. Mean visual analog scale scores were significantly higher in the LB cohort compared with controls at 0-12 hours (5.2 vs. 3.9, respectively; P = 0.0079), but insignificantly different subsequently up to 72 hours. The LB cohort and controls were not significantly different in total amount of opioids consumed, overall pain scores, or regarding how the opioid amount consumed or pain scores changed over time.ConclusionsThe use of LB in lumbar interbody fusion decreases patients' LOS but has little effect on reducing overall pain scores or opioid use in the 72-hour postoperative hospital period.
| S-EPMC7484400 | biostudies-literature
Project description:BackgroundLiposomal bupivacaine (LB) is a long-acting formulation of bupivacaine. The safety and efficacy of LB has been demonstrated across surgical procedures. However, pharmacokinetic (PK) parameters and safety of LB in the Chinese population have not been assessed.MethodsIn this single-arm, single center, phase 1, open-label study, PK and safety of local infiltration with LB 266 mg were assessed in healthy Chinese adults. Eligible participants were aged 18 to 55 years with biologic parents and grandparents of Chinese ethnicity, in generally good health (i.e., no clinically significant abnormalities), and with a body mass index (BMI) 19.0 to 24.0 kg/m2 (inclusive) and body weight ≥ 50 kg.ResultsParticipants (N = 20) were predominantly men (80 %); mean age was 32 years; and mean BMI was 21.8 kg/m2. After LB administration, mean plasma levels of bupivacaine rapidly increased during the first hour and continued to increase through 24 h; plasma levels then gradually decreased through 108 h followed by a monoexponential decrease through 312 h. Geometric mean maximum plasma concentration was 170.9 ng/mL; the highest plasma bupivacaine concentration detected in any participant was 374.0 ng/mL. Twenty-two treatment-emergent adverse events were reported (mild, n = 21; moderate, n = 1).ConclusionsAfter single-dose administration of LB, PK measures were similar to a previously reported profile in US adults. The highest observed peak plasma concentration of bupivacaine was several-fold below the plasma concentration threshold accepted as being associated with neurotoxicity or cardiotoxicity (2000-4000 ng/mL). These data support that LB is well tolerated and safe in individuals of Chinese descent.Trial registrationNCT04158102 (ClinicalTrials.gov identifier), Date of registration: November 5, 2019.
| S-EPMC8314475 | biostudies-literature
Project description:Background and Aims:Intraperitoneal local anesthetic is an effective analgesic approach in laparoscopic appendectomy in adults. The aim of the study was to compare the postoperative pain when intraperitoneal bupivacaine is administered alone versus the addition of dexmedetomidine to it in children undergoing a laparoscopic appendectomy. Methods:In this prospective randomized trial, 52 children were randomly allocated to Group B who received intraperitoneal bupivacaine 0.25% (2 mg/kg) or Group BD who received intraperitoneal bupivacaine 0.25% (2 mg/kg) plus dexmedetomidine (1 mcg/kg) for postoperative analgesia in children undergoing laparoscopic appendectomy. Postoperative pethidine consumption at day 1 was recorded and considered the primary outcome of the study. Patients were evaluated for pain scores at 0, 2, 4, 6, 12, and 24 h, time to first request of pethidine, sedation scores at 0, 2, 4, and 6 h, length of hospital stay, and parents' satisfaction. Chi-square, Fisher's exact, Student's t-test, and Mann-Whitney U-tests were used for analysis. Results:Postoperative visual analog scale scores were lower in Group BD at 2, 4, and 6 h (mean = 3, 3, 3, respectively) compared with Group B (mean = 4, 5, 4, respectively) (P < 0.05). Patients in Group BD had more sedation scores at 0, 2, and 4 h (P < 0.05), longer time to first rescue analgesia (P = 0.03), lesser rescue analgesic consumption (P = 0.02), shorter length of hospital stay (P = 0.02), and higher parents' satisfaction (P = 0.01). Conclusion:Adding dexmedetomidine to intraperitoneal bupivacaine provides adequate postoperative analgesia in children undergoing laparoscopic appendectomy.
| S-EPMC6044172 | biostudies-literature