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

NCT06213454 | Recruiting Phase 4 DMC FDA Drug

• 5 other identifiers: 2023-1099UW23039NCI-2023-10464Protocol Version 7/17/2024A532820
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Analgesia; Surgery

Keywords

laparotomy

Outcome Measures

Primary Outcomes (1)

• Total opioid use measured in oral morphine equivalents for the first 24 hours post-surgery

  Total opioid use measured in oral morphine equivalents for the first 24 hours post-surgery (including intraoperative and Post Anesthesia Care Unit (PACU) opioid utilization).

  24 hours post-surgery

Secondary Outcomes (10)

• Mean postoperative pain score for the first 24 hours post-surgery

  24 hours post-surgery

• Length of hospital stay, measured in whole hours from admission to PACU to time of discharge order placement

  estimated to be up to 3 days

• Post-operative anti-emetic use

  estimated to be up to 3 days

• Number of recorded episodes of emesis

  estimated to be up to 3 days

• Return of bowel function measured in whole hours from completion of surgery to passage of flatus

  estimated to be up to 3 days

Study Arms (2)

TAP Block plus Laparotomy

ACTIVE COMPARATOR

Drug: TAP Anesthesia

Laparotomy plus Local Wound Anesthetic

ACTIVE COMPARATOR

Drug: Surgeon-Initiated Local Anesthetic

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

Also known as: bupivacaine, liposomal bupivacaine

TAP Block plus Laparotomy

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

Laparotomy plus Local Wound Anesthetic

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and the willingness to sign a written informed consent document
• Patients undergoing exploratory laparotomy via midline vertical skin incision for gynecologic indications at UW Hospital and Clinics
• Patients must be \>18 years old
• English speaking (able to provide consent and complete questionnaires)
• Patients must have the ability to understand visual and verbal pain scales
• Patients must be eligible for TAP block placement. This will be confirmed during preoperative visit with the primary surgeon. Patient's are not eligible if they have allergies to the anesthetic medications or have had prior abdominal reconstructive surgery that would alter their abdominal wall anatomy in a way where the block would not be expected to be effective.

You may not qualify if:

• Known allergy to local anesthetics.
• Known history of chronic pain disorders and/or chronic opioid use defined as greater than 10mg of PO morphine or equivalent used daily for at least 30 days prior to enrollment.
• Patient has a history of opioid dependence requiring rehabilitation or the use of opioid antagonists.
• Patients with a planned exploration with biopsies (no organs removed) will be excluded from the study.
• Individuals who are pregnant, lactating or planning on becoming pregnant during the study.
• Significant liver disease that would inhibit prescription of opioids.
• Significant kidney disease that would inhibit administration of gabapentin.
• Not suitable for study participation due to other reasons at the discretion of the investigators.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Hospitals and Clinics (UWHC)

Madison, Wisconsin, 53726, United States

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Sumer Wallace, MD

  UW Carbone Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cancer Connect

CONTACT

800-622-8922; clinicaltrials@cancer.wisc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized, unblinded, single-center trial testing the hypothesis that surgeon-initiated wound infiltration with local anesthetic is non-inferior in providing postoperative pain control when compared with preoperative TAP analgesia.

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 19, 2024
• Study Start: March 26, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)