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NCT Number: NCT06213454

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Wisconsin Hospitals and Clinics (UWHC)

Madison, Wisconsin, 53726, United States

Location status: Recruiting

About this study

Primary Objective

  • To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on pain control in subjects undergoing laparotomy.

Secondary Objectives

  • To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on subject-rated perception of pain in subjects undergoing laparotomy.
  • To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on length of hospital stay in subjects undergoing laparotomy.
  • To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on postoperative anti-emetic use and number of recorded episodes of emesis in subjects undergoing laparotomy.
  • To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on return of bowel function in subjects undergoing laparotomy.
  • To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on subject satisfaction in subjects undergoing laparotomy.
  • To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on postoperative complications in subjects undergoing laparotomy.
  • To evaluate the effects of preoperative TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on readmission rates in subjects undergoing laparotomy.
  • To evaluate the cost of care associated with TAP analgesia compared to surgeon-initiated wound infiltration with local anesthetic on readmission rates in subjects undergoing laparotomy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Other names: bupivacaine, liposomal bupivacaine

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

Primary outcomes

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

    Time frame: 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).

Secondary outcomes

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

    Time frame: 24 hours post-surgery

    Mean postoperative pain score for the first 24 hours post-surgery, measured by the Numeric Rating Scale (NRS), which rates pain on a 0-10 scale (collected routinely on the post-operative floor). Higher numbers indicate worse pain.

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

    Time frame: estimated to be up to 3 days

  3. Post-operative anti-emetic use

    Time frame: estimated to be up to 3 days

    A study team member will review the patient's medical chart to record the number of times an anti-emetic was given to the subject.

  4. Number of recorded episodes of emesis

    Time frame: estimated to be up to 3 days

    A study team member will review the patient's medical chart to record number of times the hospital staff observed a participant vomit.

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

    Time frame: estimated to be up to 3 days

  6. Participant Satisfaction at Postoperative Visit measured by two pain questions from the QoR-15 Patient Reported Outcomes Survey Score

    Time frame: post-operative visit (up to 60 days)

    Scores are from 0-10 where 0 is pain all of the time and 10 is pain none of the time.

  7. Readmission rate measured by readmission in the 30 days following surgery

    Time frame: up to 30 days

  8. Cost of care measured by aggregate cost of hospitalization following discharge from surgical hospital stay

    Time frame: estimated to be up to 3 days

  9. Summary of Post-operative Complications

    Time frame: up to 30 days post-operatively

    Postoperative complications, as defined by urinary tract infections, thromboembolic events, pneumonia, blood transfusion, cardiac events, falls, and electrolyte disturbances will be summarized by type and number of complications.

  10. Time to First Ambulation measured in hours

    Time frame: estimated to be within 72 hours post-surgery

    A study team member will review the participant's medical chart to record the interval (in hours) from completion of surgery to first ambulation after surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Cancer Connect

CONTACT

[email protected]

800-622-8922

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 19, 2024
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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