RECRUITING

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-03-26

Study Completion:2025-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06213454

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Cancer Connect

CONTACT

800-622-8922

clinicaltrials@cancer.wisc.edu

Principal Investigator

Sumer Wallace, MD

PRINCIPAL_INVESTIGATOR

UW Carbone Cancer Center

Study Locations (Sites)

University of Wisconsin Hospitals and Clinics (UWHC)

Madison, Wisconsin, 53726

United States

Collaborators and Investigators

Sponsor: University of Wisconsin, Madison

Sumer Wallace, MD, PRINCIPAL_INVESTIGATOR, UW Carbone Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-26

Study Completion Date2025-06

Study Record Updates

Study Start Date2024-03-26

Study Completion Date2025-06

Terms related to this study

Keywords Provided by Researchers

laparotomy

Additional Relevant MeSH Terms

Analgesia
Surgery