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TAP Block for Postoperative Pain in Endometrial Cancer Surgery

Phase 3
Waitlist Available
Led By Young B Kim, MD
Research Sponsored by Tufts Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-80
Diagnosis of endometrial cancer or endometrial intraepithelial neoplasia
Must not have
Severe hepatic or renal impairment
Emergency surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial aims to reduce postoperative pain & opiate usage while avoiding adverse effects by using non-opiate meds, nerve blocks & the TAP block.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Possible side effects include reactions at the injection site like pain or swelling, nausea, constipation from any opiates used alongside the blocks. Allergic reactions are possible but only in patients without known allergies to the medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old.
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I have been diagnosed with endometrial cancer or a precancerous condition of the uterus.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe liver or kidney problems.
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I need surgery urgently.
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My hysterectomy was not due to endometrial cancer or precancerous conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Reduced opiate use in both TAP block arms.
Secondary study objectives
Improvement in patient satisfaction regarding pain control
Incidence of Treatment-Emergent Adverse Events
Increase in opiate-free participants by day 7
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Active Control
Group I: No TAP blockActive Control1 Intervention
Group II: TAP block with liposomal and plain bupivacaineActive Control2 Interventions
Group III: TAP block with plain bupivacaine aloneActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Tufts Medical CenterLead Sponsor
263 Previous Clinical Trials
264,323 Total Patients Enrolled
Young B Kim, MDPrincipal InvestigatorTufts Medical Center

Media Library

TAP block with liposomal and plain bupivacaine Clinical Trial Eligibility Overview. Trial Name: NCT05763667 — Phase 3
Postoperative Pain Research Study Groups: No TAP block, TAP block with liposomal and plain bupivacaine, TAP block with plain bupivacaine alone
Postoperative Pain Clinical Trial 2023: TAP block with liposomal and plain bupivacaine Highlights & Side Effects. Trial Name: NCT05763667 — Phase 3
TAP block with liposomal and plain bupivacaine 2023 Treatment Timeline for Medical Study. Trial Name: NCT05763667 — Phase 3
~8 spots leftby Dec 2025
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