Transversus Abdominis Plane Block Compared to Local Anesthetic Wound Infiltration in Gynecologic Oncology Surgery

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT06213454
Phase
PHASE4
Status
Recruiting

Conditions

  • Analgesia
  • Surgery

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TAP Anesthesia — DRUG
    ultrasound guided TAP block, 133 mg of liposomal bupivacaine and 15 mL of 0.25% bupivacaine deposited into the TAP on each side for a total of two injections
  • Surgeon-Initiated Local Anesthetic — DRUG
    266 mg of liposomal bupivacaine and 30 mL of 0.25% bupivacaine diluted in 130 mL of normal saline (160 mL of solution), 40 mL fascial injection and 40 mL skin injection on either side of the wound

Study Details

This study is being done to see if preoperative transversus abdominis plane (TAP) analgesia will provide similar postoperative pain control, hospital length of stay, and postoperative outcomes compared to surgeon-initiated wound infiltration with local anesthetic in participants undergoing laparotomy for gynecologic indications.

Key Dates

Start date
Mar 26, 2024
Status verified
May 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: TAP Block plus Laparotomy
  • Active Comparator: Laparotomy plus Local Wound Anesthetic

Primary Outcome Measure

Total opioid use measured in oral morphine equivalents for the first 24 hours post-surgery [ Time Frame: 24 hours post-surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Wisconsin Hospitals and Clinics (UWHC)MadisonWisconsin53726-

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