TAP Block for Postoperative Pain in Endometrial Cancer Surgery

Recruiting in Palo Alto (17 mi)

Overseen byYoung B Kim, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Tufts Medical Center

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Modern postoperative pain management aims to optimizing pain relief while minimizing opiate usage. While opiates are effective for pain relief, they result in common adverse effects such as nausea, constipation, and urinary retention, and most importantly present a long-term risk of abuse and dependency. Commonly used approaches include non-opiate pain medications such as acetominophen and non-steroidal anti-inflammatory agents, as well as regional nerve blocks such as epidurals. The transversus abdominis plane (TAP) block is a fascial plane block performed by injecting local anesthetic into the plane superficial to the transversus abdominis muscle where the anterior rami of the spinal nerves course to provide sensory innervation to the abdominal wall. The injections are generally placed either subcostally or at the midaxillary line bilaterally. The TAP block has been shown to be effective in reducing pain scores and opiate usage in some randomized studies but not others in patients undergoing various abdominal surgeries. There is great variation in method of administration, sites injected, and local anesthetics used, which may in part account for the heterogeneity of trial results.

Research Team

Young B Kim, MD

Principal Investigator

Tufts Medical Center

Eligibility Criteria

This trial is for women aged 18-80 undergoing minimally invasive hysterectomy for endometrial cancer or pre-cancer, who can consent to the study. It excludes those with severe allergies to bupivacaine, high surgical risk (ASA IV/V), emergency surgery cases, pregnant or breastfeeding women, non-endometrial cancer surgeries, chronic opiate users, and those with serious liver or kidney issues.

Inclusion Criteria

Able to consent to study

I am between 18 and 80 years old.

I am having a laparoscopic or robotic hysterectomy, possibly with additional procedures.

See 1 more

Exclusion Criteria

I have severe liver or kidney problems.

I need surgery urgently.

You are currently using opiates for a long time.

See 4 more

Treatment Details

Interventions

Bupivacaine (Local Anesthetic)
Liposomal Bupivacaine (Local Anesthetic)
Transversus Abdominis Plane (TAP) Block (Local Anesthetic)

Trial OverviewThe trial tests a regional nerve block called TAP Block using two local anesthetics: Liposomal bupivacaine and Bupivacain. The goal is to manage postoperative pain effectively while reducing reliance on opiates that have side effects and addiction risks.

Participant Groups

3Treatment groups

Active Control

Group I: No TAP blockActive Control1 Intervention

Group II: TAP block with plain bupivacaine aloneActive Control1 Intervention

Group III: TAP block with liposomal and plain bupivacaineActive Control2 Interventions