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

University of Wisconsin (UW)

Status and phase

Enrolling

Phase 4

Conditions

Surgery

Analgesia

Treatments

Drug: Surgeon-Initiated Local Anesthetic

Drug: TAP Anesthesia

Study type

Interventional

Funder types

Other

Identifiers

NCT06213454

NCI-2023-10464 (Registry Identifier)

UW23039 (Other Identifier)

2023-1099

A532820 (Other Identifier)

Protocol Version 7/17/2024 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.