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Liposome bupivacaine (EXPAREL®) for extended pain relief in patients undergoing ileostomy reversal at a single institution with a fast-track discharge protocol: an IMPROVE Phase IV health economics trial.

ABSTRACT: BACKGROUND:Postoperative opioid use following ileostomy reversal procedures contributes to postoperative ileus. We assessed the impact of a liposome bupivacaine-based, opioid-sparing multimodal analgesia regimen versus a standard opioid-based analgesia regimen on postsurgical opioid use. We also assessed health economic outcomes in patients undergoing ileostomy reversal at our institution, which employs an enhanced recovery discharge protocol. METHODS:In this single-center, open-label study, patients undergoing ileostomy reversal received postsurgical pain therapy via multimodal analgesia that included a single intraoperative administration of liposome bupivacaine or opioid-based patient-controlled analgesia (PCA) with intravenous morphine or hydromorphone. Rescue analgesia (intravenous [IV] opioids and/or oral opioid + acetaminophen) was available to all patients. Primary efficacy measures included postsurgical opioid use, hospital length of stay (LOS), and hospitalization costs. Secondary measures included: time to first rescue opioid use; patient satisfaction with analgesia; additional medical intervention; and opioid-related adverse events. RESULTS:Forty-three patients were enrolled and met eligibility criteria (IV opioid PCA group = 20; liposome bupivacaine-based multimodal analgesia group = 23). Postsurgical opioid use was significantly less in the multimodal analgesia group compared with the IV opioid PCA group (mean [standard deviation]: 38 mg [46 mg] versus 68 mg [47 mg]; P = 0.004). Postsurgical LOS between-group differences (median: 3.0 days versus 3.8 days) and geometric mean hospitalization costs (US $6,611 versus US$6,790) favored the multimodal analgesic group but did not achieve statistical significance. Median time to first opioid use was 1.1 hours versus 0.7 hours in the multimodal analgesia and IV opioid PCA groups, respectively; P = 0.035. Two patients in the multimodal analgesia group and one in the IV opioid PCA group experienced opioid-related adverse events. CONCLUSION:A liposome bupivacaine-based multimodal analgesic regimen reduced postoperative opioid consumption in patients undergoing ileostomy reversal under a fast-track discharge protocol. A reduction of 21% in LOS (0.8 days) was noted which, although not statistically significant, may be considered clinically meaningful given the already aggressive fast-track discharge program.

SUBMITTER: Vogel JD

PROVIDER: S-EPMC3735342 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

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Liposome bupivacaine (EXPAREL®) for extended pain relief in patients undergoing ileostomy reversal at a single institution with a fast-track discharge protocol: an IMPROVE Phase IV health economics trial.

Vogel Jon D JD

Journal of pain research 20130729

<h4>Background</h4>Postoperative opioid use following ileostomy reversal procedures contributes to postoperative ileus. We assessed the impact of a liposome bupivacaine-based, opioid-sparing multimodal analgesia regimen versus a standard opioid-based analgesia regimen on postsurgical opioid use. We also assessed health economic outcomes in patients undergoing ileostomy reversal at our institution, which employs an enhanced recovery discharge protocol.<h4>Methods</h4>In this single-center, open-l ...[more]

PMID: 23935387

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Project description:BackgroundThe majority of surgical patients experience significant levels of pain after a procedure. While opioid analgesics have been a mainstay of postsurgical analgesic regimens, recent evidence has supported the use of multimodal therapy as a way to decrease opioid usage with its concomitant opioid-related adverse events. The goal of multimodal therapy is to minimize the negative effects of these events on clinical and economic outcomes. The purpose of this study was to assess the opioid burden and health economic outcomes in patients undergoing open colectomy who received a liposomal bupivacaine-based multimodal analgesic regimen as compared with a standard opioid-based regimen for postsurgical pain.MethodsIn this open-label, single-center, sequential-cohort study, adults undergoing open colectomy were assigned to treatment via patient-controlled analgesia with opioids (first cohort) or multimodal analgesia therapy including a single administration of liposomal bupivacaine (second cohort). Both treatment groups were offered rescue analgesia as needed. The main outcome measures were total mg amount of opioids consumed after surgery, total hospital costs, and length of hospital stay. Adverse events, including opioid-related adverse events, were recorded.ResultsThirty-nine patients were enrolled, 18 in the opioid-based analgesia group and 21 in the multimodal analgesia group. Mean total amount of postsurgical opioids consumed was significantly less in the multimodal analgesia group (57 mg) compared with the opioid analgesia group (115 mg; P = 0.025). The average total cost of hospitalization in the multimodal group was $8766 versus $11,850 in the opioid group (P = 0.027), and the median length of hospital stay was 2.0 days versus 4.9 days, respectively (P = 0.004).ConclusionThis study confirmed that a liposomal bupivacaine-based multimodal analgesic regimen resulted in less opioid consumption, lower hospital costs, and a shorter length of stay than a standard opioid-based analgesic regimen for postsurgical pain in patients undergoing open colectomy.

Project description:BackgroundRectal cancer is a common cancer worldwide. Surgery for rectal cancer with low anterior resection often includes the formation of a temporary protective loop ileostomy. The temporary ostomy is later reversed in a separate operation. One complication following stoma closure is the development of a hernia at the former stoma site, and this has been reported in 7-15% of patients. The best method to avoid hernia after stoma closure is unclear. The most common closure is by suturing only, but different forms of mesh have been tried. Biological mesh has in a randomized trial halved hernia incidence after stoma reversal. Biosynthetic mesh and retromuscular mesh are currently being evaluated in ongoing studies.MethodsThe present multicenter, double-blinded, randomized, controlled study will compare standard suture closure of the abdominal wall in loop ileostomy reversal with retromuscular synthetic mesh at the stoma site. The study has been approved by the Regional Ethical Review board in Stockholm. Patients aged 18-90 years, operated on with low anterior resection and a protective loop ileostomy for rectal cancer and planned for ileostomy reversal, will be considered for inclusion in the study. Randomization will be 1:1 on the operation day with concealed envelopes. The estimated sample size is intended to evaluate the superiority of the experimental arm and to detect a reduction of hernia occurrence from 12 to 3%. The operation method is blinded to the patients and in the chart and for the observer at the 30-day follow-up. The main outcome is hernia occurrence at the stoma site within 3 years postoperatively, diagnosed through CT with strain. Secondary outcomes are operation time, length of hospital stay, pain, and 30-day complications.DiscussionThis double-blinded randomized controlled superiority study will compare retromuscular synthetic mesh during the closure of loop ileostomy to standard care. If this study can show a lower frequency of hernia with the use of prophylactic mesh, it may lead to new surgical guidelines during stoma closure.Trial registrationClinicalTrials.gov NCT03720262. Registered on October 25, 2018.

Project description:BackgroundTransversus abdominis plane (TAP) infiltration has been increasingly used for postsurgical analgesia in abdominal/pelvic procedures; however, duration/extent of analgesia with standard local anesthetics is limited. This pilot study assessed the preliminary efficacy and safety of two volumes of liposome bupivacaine administered via TAP infiltration in patients undergoing robotic laparoscopic prostatectomy.MethodsIn this single-center, open-label, prospective study, patients older than 18 years received TAP infiltration with liposome bupivacaine immediately after surgery. The first 12 patients received a total volume of 20 mL liposome bupivacaine (266 mg); the next 12 received 40 mL liposome bupivacaine (266 mg). The liposome bupivacaine was diluted with 0.9% normal saline. The primary efficacy measure was duration of analgesia, measured by time to first opioid administration. Secondary outcome measures included patient-assessed pain scores, opioid use, and opioid-related adverse events (AEs).ResultsTwenty-four patients received liposome bupivacaine (20 mL, n=12; 40 mL, n=12) and were included in the primary analysis. Three refused participation in a 10-day follow-up visit and did not complete the study. Median time to first opioid administration after surgery was 23 and 26 minutes for the 20 and 40 mL groups, respectively. Mean total amount of postsurgical opioids ranged from 25.4 to 27.3 mg; after hospital discharge to day 10, both groups required a mean of 0.7 oxycodone/acetaminophen tablets/day. Mean pain scores of 4.4 and 5.3 were reported at 1 hour and 3.1 and 3.9 at 2 hours postsurgery, with 20 and 40 mL doses, respectively. Neither group had mean scores higher than 3.0 at any further assessments. No opioid-related or treatment-related serious AEs were reported.ConclusionMedian time to first opioid administration did not differ between the two groups. No differences in secondary outcomes were observed on the basis of volume administered. These initial findings suggest further study of liposome bupivacaine administered via TAP infiltration as part of a multimodal analgesic regimen in laparoscopic robotic prostatectomy may be warranted.

Dataset Information

Liposome bupivacaine (EXPAREL®) for extended pain relief in patients undergoing ileostomy reversal at a single institution with a fast-track discharge protocol: an IMPROVE Phase IV health economics trial.

Publications

Liposome bupivacaine (EXPAREL®) for extended pain relief in patients undergoing ileostomy reversal at a single institution with a fast-track discharge protocol: an IMPROVE Phase IV health economics trial.

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