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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:Diverting loop ileostomy has become routine in low anterior resection (LAR) for rectal cancer. The optimal time for stoma reversal is controversial. The aim of the present study was to compare the results after planned early (within 8-12 days) versus late (> 3 months) stoma reversal. The primary outcomes were morbidity and mortality, as measured by the Comprehensive Complication Index (CCI) within 30 days after stoma reversal, and the secondary outcomes were morbidity and mortality within 90 days after LAR. This was a multicentre trial including all patients scheduled for anterior low resection for rectal cancer with curative intent. Inclusion period was from April 2011 to December 2018. All patients were randomized 1:1 prior to surgery. Among 257 consecutive and eligible patients, a total of 214 patients were randomized: 107 patients to early stoma reversal and 107 to late reversal. A total of 68 patients were excluded for various reasons, and 146 patients completed the study, with 77 in the early reversal group and 69 in the late reversal group. The patients were asked to complete the Gastrointestinal Quality of Life Index before surgery (baseline) and at 6 and 12 months after LAR. Ostomy-related complications were evaluated by dedicated ostomy staff using the validated DET score. ClinicalTrials Identifier: NCT01865071. Fifty-three patients (69%) in the early reversal group and 60 patients (87%) in the late reversal group received the intended treatment. There were no significant differences in CCI within 90 days after index surgery with the LAR and within 30 days after stoma reversal between the two groups. There were no differences in patient-reported quality of life but significantly more stoma-related complications in the late reversal group. A total of 5 patients experienced anastomotic leakage (AL) after stoma reversal, 4 in the early reversal group and one in the late reversal group. Early and late stoma reversal showed similar outcomes in terms of overall complications and quality of life. The risk of developing anastomotic leakage after early ostomy reversal is a concern.

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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