Liposomal Bupivacaine for Bowel Surgery Pain Management
(TAPLIP Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Hartford Hospital
Must not be taking: Antithrombotics, Long opioids
Disqualifiers: Metastatic cancers, Coagulopathy, Substance abuse, others
Stay on Your Current Meds
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This study will be a single center, prospective triple blinded randomized controlled study, comparing the use of liposomal bupivacaine (Exparel) to regular bupivacaine with adjuncts in bilateral mid-abdominal transverse abdominis plane (TAP) blocks for patients undergoing laparoscopic colectomy procedures.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on antithrombotic medications or long-acting opioids. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug Liposomal Bupivacaine for managing pain after bowel surgery?
Research shows that Liposomal Bupivacaine (Exparel) can provide pain relief for up to 3-4 days after surgery and reduce the need for additional pain medication, as seen in studies involving orthopedic and soft-tissue surgeries.
12345Is liposomal bupivacaine generally safe for use in humans?
Liposomal bupivacaine (Exparel) has been used safely in various surgical settings, including in children, with some studies noting mild inflammation and tissue reactions similar to other bupivacaine formulations. No significant nerve damage was observed in animal studies, but monitoring for local tissue injury is recommended.
12346How is liposomal bupivacaine different from other drugs for managing pain after bowel surgery?
Liposomal bupivacaine is unique because it is a long-acting local anesthetic that releases the drug over 72 hours, providing extended pain relief after surgery. This formulation reduces the need for opioids and is administered directly at the surgical site, unlike traditional bupivacaine, which may require more frequent dosing.
12378Eligibility Criteria
This trial is for English-speaking patients scheduled for elective laparoscopic colectomy with an ASA score I-IV. Excluded are those with emergency surgery, metastatic cancers, planned multi-organ resection, TAP block contraindications like anatomical abnormalities or infection at the injection site, current colostomies, severe coagulation disorders, underweight (<40kg), chronic opioid use or substance abuse within 3 months.Inclusion Criteria
I am scheduled for a specific colon surgery by a study surgeon.
I speak English.
Patients with American Society of Anesthesiology (ASA) physical status score I- IV
Exclusion Criteria
I had emergency surgery to remove part of my colon.
I weigh less than 40 kg.
I am scheduled for surgery to remove multiple organs, including part of my colon.
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either liposomal bupivacaine or regular bupivacaine in TAP blocks during laparoscopic colectomy procedures
Immediate perioperative period
1 visit (in-person)
Postoperative Monitoring
Participants are monitored for pain scores, opioid consumption, and nausea/vomiting for up to 6 days post-surgery
6 days
Daily monitoring (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including block complications and overall satisfaction
30 days
1 visit (in-person or phone call)
Participant Groups
The study compares liposomal bupivacaine (Exparel) to regular bupivacaine in bilateral mid-abdominal TAP blocks during laparoscopic colectomy. It's a single-center trial where participants are randomly assigned and triple-blinded to determine which medication provides better pain control.
2Treatment groups
Experimental Treatment
Active Control
Group I: Liposomal Bupivacaine/Bupivacaine HCLExperimental Treatment2 Interventions
20mL 1.3% Exparel (266mg) + 60mL 0.25% bupivacaine (150mg) + 20mL normal saline. Total 100mL divided into 10mL syringes, 30 mL left TAP, 30mL right TAP, 20mL left rectus, 20mL right rectus.
Group II: Regular Bupivacaine ArmActive Control1 Intervention
80mL 0.25% bupivacaine (200mg) + 300mcg (0.3mL) epinephrine + 5mg (0.5mL) preservative free dexamethasone + 20mL of normal saline. Total 100mL divided into 10mL syringes, 30mL left TAP, 30mL right TAP, 20mL left rectus, 20mL right rectus.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Hartford HospitalHartford, CT
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Who Is Running the Clinical Trial?
Hartford HospitalLead Sponsor
References
Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. [2022]Liposome bupivacaine (Exparel) is a multivesicular liposomal formulation of bupivacaine currently approved in the United States for single-dose administration into the surgical site to provide postsurgical analgesia. This retrospective analysis examined safety data from clinical trials involving the off-label use of this formulation in peripheral nerve blocks.
Perineural dexamethasone attenuates liposomal bupivacaine-induced delayed neural inflammation in mice in vivo. [2020]Liposomal bupivacaine (Exparel®) is a sustained-release formulation of bupivacaine for use in surgical infiltration anaesthesia. We analysed the histological nerve toxicity and clinical effectiveness of perineural Exparel® alone or with added dexamethasone in a mouse model.
Extended Release Liposomal Bupivacaine Injection (Exparel) for Early Postoperative Pain Control Following Pharyngoplasty. [2018]Liposomal bupivacaine (LB, Exparel) is a long-acting local anesthetic reported to decrease postoperative. The authors demonstrate the first safe use of LB in pediatric patients with improved pain control following pharyngoplasty.
Neurological and histological outcomes after subarachnoid injection of a liposomal bupivacaine suspension in pigs: a pilot study. [2019]An injectable liposomal bupivacaine suspension (EXPAREL™) is approved by the US Food and Drug Administration for analgesia by tissue infiltration and interscalene brachial plexus, but not for use in the neuraxial space. This pilot study describes neurological and histological outcomes of escalating doses of this extended-release formulation of bupivacaine after subarachnoid administration.
Evaluation of DepoFoam(®) bupivacaine for the treatment of postsurgical pain. [2014]SUMMARY An extended-release, multivesicular liposome-encapsulated form of the local anesthetic bupivacaine, DepoFoam(®) bupivacaine (proposed proprietary name EXPAREL™), is in development for use as part of a multimodal regimen for the treatment of postsurgical pain. Placebo- and active-controlled clinical trials in patients who have undergone either orthopedic or soft-tissue procedures indicate that a single local administration into the surgical site results in analgesic activity for up to 3-4 days and decreases the use of opioid rescue medication. The safety profile of DepoFoam bupivacaine appears to be similar to that of bupivacaine HCl, and adverse events are dose-related.
Multivesicular liposomal bupivacaine at the sciatic nerve. [2022]Clinical translation of sustained release formulations for local anesthetics has been limited by adverse tissue reaction. Exparel™ (DepoFoam bupivacaine) is a new liposomal local anesthetic formulation whose biocompatibility near nerve tissue is not well characterized. Exparel™ injection caused sciatic nerve blockade in rats lasting 240 min compared to 120 min for 0.5% (w/v) bupivacaine HCl and 210 min for 1.31% (w/v) bupivacaine HCl (same bupivacaine content as Exparel™). On histologic sections four days after injection, median inflammation scores in the Exparel™ group (2.5 of 4) were slightly higher than in groups treated with bupivacaine solutions (score 2). Myotoxicity scores in the Exparel™ group (2.5 of 6) were similar to in the 0.5% (w/v) bupivacaine HCl group (3), but significantly less than in the 1.31% (w/v) bupivacaine HCl group (5). After two weeks, inflammation from Exparel™ (score 2 of 6) was greater than from 0.5% (w/v) bupivacaine HCl (1) and similar to that from 1.31% (w/v) bupivacaine HCl (1). Myotoxicity in all three groups was not statistically significantly different. No neurotoxicity was detected in any group. Tissue reaction to Exparel™ was similar to that of 0.5% (w/v) bupivacaine HCl. Surveillance for local tissue injury will be important during future clinical evaluation.
Bupivacaine liposomal versus bupivacaine: comparative review. [2021]Bupivacaine liposomal injection was recently approved by the US Food and Drug Administration (FDA) as a local anesthetic for use in management of postsurgical pain in adults. When compared to placebo, bupivacaine liposomal decreases postoperative pain and opioid use. This review examines the efficacy of bupivacaine liposomal when compared to conventional bupivacaine ± epinephrine using published and unpublished data provided to the FDA by the manufacturer.
Liposomal versus plain bupivacaine for pain control following vaginal reconstruction. [2023]Liposomal bupivacaine (LB) is a depot formulation of bupivacaine, which releases the drug over 72 hours to prolong local pain control. This retrospective study compares the effect of using LB versus plain bupivacaine on postoperative pain control, length of hospital stay and cost among patients undergoing vaginal reconstructive surgery.