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CompletedNCT06213454Updated Sep 29, 2026

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

A Phase 4 interventional study of TAP Anesthesia and Surgeon-Initiated Local Anesthetic in Analgesia and Surgery, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by University of Wisconsin, Madison · Phase 4, Interventional, and Supportive care

Updated Sep 29, 2026Now CompletedGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
82
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the detailed description

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.
02

Conditions studied

  • Analgesia
  • Surgery

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Keywords

  • laparotomy
03

In context

Agnosia

1,190 studies on the registry are indexed under Agnosia; 508 are open to participants now.

This study's enrollment of 82 is close to the median of 78 across 1,024 interventional studies indexed under Agnosia.

Browse Agnosia studies →

Lead sponsor

University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.

Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
82 participants (actual)

Study arms

  • Active comparator
    TAP Block plus Laparotomy

    Drug: TAP Anesthesia

  • Active comparator
    Laparotomy plus Local Wound Anesthetic

    Drug: Surgeon-Initiated Local Anesthetic

Interventions

  • DrugTAP Anesthesia

    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

  • DrugSurgeon-Initiated Local Anesthetic

    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

06

What researchers measure

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).

    Time frame: 24 hours post-surgery

Secondary outcomes

  1. Mean postoperative pain score for the first 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.

    Time frame: 24 hours post-surgery

  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

    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.

    Time frame: estimated to be up to 3 days

  4. Number of recorded episodes of emesis

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

    Time frame: estimated to be up to 3 days

  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

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

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

  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

    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.

    Time frame: up to 30 days post-operatively

  10. Time to First Ambulation measured in hours

    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.

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

07

Study locations

1 site
  • University of Wisconsin Hospitals and Clinics (UWHC)
    Madison, Wisconsin 53726, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Active, not recruiting→Completed
changed Sep 29, 2026
Show all 1 update
  1. Sep 29, 2026
    Active, not recruiting→Completed
    + 2 other changes: verification date and date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06213454
Lead sponsor
University of Wisconsin, Madison
Responsible party
Sponsor
First posted
Jan 19, 2024
Start date
Mar 26, 2024
Primary completion
Aug 12, 2026
Completion
Sep 10, 2026
Last update
Sep 29, 2026

Study contacts

Sumer Wallace, MD
principal investigator · UW Carbone Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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