Comparing two methods of pain control after gynecologic surgery
Transversus Abdominis Plane Block Compared to Local Anesthetic Wound Infiltration in Gynecologic Oncology Surgery
This study is testing whether a specific type of pain relief given before surgery works better than a local anesthetic applied by the surgeon for women having gynecologic surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT06213454 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of preoperative transversus abdominis plane (TAP) analgesia versus surgeon-initiated local anesthetic wound infiltration for pain management in patients undergoing laparotomy for gynecologic conditions. The primary objective is to assess pain control, while secondary objectives include evaluating hospital stay length, postoperative complications, and patient satisfaction. Participants will be monitored for pain perception, anti-emetic use, and bowel function recovery. The study aims to determine which method provides better postoperative outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old undergoing exploratory laparotomy for gynecologic indications at the University of Wisconsin Hospitals and Clinics.
Not a fit: Patients with known allergies to local anesthetics or chronic pain disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies and shorter hospital stays for patients undergoing gynecologic surgery.
How similar studies have performed: Previous studies have shown promising results with TAP analgesia in similar surgical contexts, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Madison, Wisconsin
- University of Wisconsin Hospitals and Clinics (UWHC) — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Sumer Wallace, MD — UW Carbone Cancer Center
- Study coordinator: Cancer Connect
- Email: clinicaltrials@cancer.wisc.edu
- Phone: 800-622-8922
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.