Bilateral TAP and RS Blocks Using Liposomal Bupivacaine/Bupivacaine vs. Regular Bupivacaine in Laparoscopic Colectomy

Last updated: March 28, 2025
Sponsor: Hartford Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Inflammatory Bowel Disease

Gastrointestinal Diseases And Disorders

Ulcerative Colitis (Pediatric)

Treatment

Bupivacaine HCL

Liposomal Bupivicaine/Bupivacaine Admixture

Clinical Study ID

NCT05224089
HHC-2021-0331
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients scheduled for elective laparoscopic colectomy surgery to be performed byone of the 4 colorectal surgeons in the study.

  • English speaking patients

  • Patients with American Society of Anesthesiology (ASA) physical status score I- IV

Exclusion

Exclusion Criteria:

  1. Emergency laparoscopic colectomy surgery

  2. Patients with distant metastatic cancers (e.g. bone, lung, brain).

  3. Scheduled for multi organs resection surgery in addition to colectomy.

  4. Patients with contraindications to TAP or RS blocks including but not limited toanatomical abnormality, previous surgical intervention that limits or preventsreceiving bilateral TAP blocks (e.g. surgical mesh at the site of TAP or RS block),or infection at the injection site.

  5. Current colostomies.

  6. History of allergy to local anesthetics.

  7. Coagulopathy or coagulation disorder. Also patients who are receiving antithromboticmedications as a contraindication to receiving single shot peripheral nerve blockadeas per the most recent American Society of Regional Anesthesiology (ASRA)guidelines.16

  8. Weight < 40 kg, as 40 mL of Bupivacaine 0.25%, or combination of 20 mL ofbupivacaine 0.25% with 20 mL of liposomal bupivacaine is greater than the maximaldose allowed, given concern for local anesthetic toxicity.

  9. Patients who take long acting opioid medication, or on continuous opioid > 50 MMEper day for at least 30 days within 90 days prior to surgery. Also patients who havechronic pain syndrome with a recent preoperative consultation to the chronic painservice.

  10. Patients with current substance abuse, or history of substance abuse within 3months, this includes any illicit drugs or excessive alcohol consumption as defined 4 or more drinks per day or 8 or more drinks per week for women and 5 or more drinksper day or 15 or more drinks per week for men.15

  11. Pregnant, nursing, or planning to become pregnant during the study or within 1 monthpostoperatively

  12. Refusal or lack of providing the study consent

Study Design

Total Participants: 114
Treatment Group(s): 2
Primary Treatment: Bupivacaine HCL
Phase: 4
Study Start date:
April 27, 2022
Estimated Completion Date:
February 28, 2026

Connect with a study center

  • Hartford Hospital

    Hartford, Connecticut 06102
    United States

    Active - Recruiting

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