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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 days

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 days

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Reduced opiate use in both TAP block arms.

Secondary outcome measures

Improvement in patient satisfaction regarding pain control

Incidence of Treatment-Emergent Adverse Events

Increase in opiate-free participants by day 7

+1 more

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Tufts Medical CenterLead Sponsor

252 Previous Clinical Trials

252,983 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there eligibility criteria I must meet to be part of this trial?

"Eligibility for this medical experiment necessitates that applicants have suffered post-operative discomfort and their age is between 18 and 80. At present, there are approximately 144 participants needed."

Answered by AI

Is the subject pool of this research endeavor restricted to adults?

"As per the inclusion criteria, individuals aged 18 to 80 are eligible for this medical trial. Separately, there exist 57 trials targeting participants below the age of consent and 426 trials exclusively concerning patients above 65 years old."

Answered by AI

Is enrollment for this clinical research still open?

"According to clinicaltrials.gov, this particular medical experiment is not currently recruiting patients. The trial was first posted on June 1st 2023 and was last updated February 28th 2023. Although the study does not need more participants at present, there are 529 other trials that do require volunteers."

Answered by AI

How perilous is the application of TAP block with liposomal and conventional bupivacaine for those being treated?

"The safety of TAP block with liposomal and plain bupivacaine was judged to be 3 out of 3 by our Power team, due to the extensive clinical data that supports its efficacy as well as multiple rounds backing up its security."

Answered by AI

Recent research and studies

BmjJournal

Rates and Risk Factors for Prolonged Opioid Use After Major Surgery: Population Based Cohort Study

Clarke, H., N. Soneji, D. T. Ko, L. Yun, and D. N. Wijeysundera. 2014. “Rates and Risk Factors for Prolonged Opioid Use After Major Surgery: Population Based Cohort Study”. Bmj. BMJ. doi:10.1136/bmj.g1251.

Gynecologic OncologyJournal

Ultrasound Guided Subcostal Transversus Abdominis Plane (TAP) Infiltration with Liposomal Bupivacaine for Patients Undergoing Robotic Assisted Hysterectomy: A Prospective Randomized Controlled Study

Hutchins, Jacob, Daniel Delaney, Rachel Isaksson Vogel, Rahel G. Ghebre, Levi S. Downs Jr., Linda Carson, Sally Mullany, Deanna Teoh, and Melissa A. Geller. 2015. “Ultrasound Guided Subcostal Transversus Abdominis Plane (TAP) Infiltration with Liposomal Bupivacaine for Patients Undergoing Robotic Assisted Hysterectomy: A Prospective Randomized Controlled Study”. Gynecologic Oncology. Elsevier BV. doi:10.1016/j.ygyno.2015.06.008.

Journal of Pain ResearchJournal

<p>ultrasound-guided Subcostal Transversus Abdominis Plane Block with Liposomal Bupivacaine Compared to Bupivacaine Infiltration for Patients Undergoing Robotic-assisted and Laparoscopic Hysterectomy: A Prospective Randomized Study</p>

Hutchins, Jacob, Peter Argenta, Aaron Berg, Jason Habeck, Alexander Kaizer, and Melissa A Geller. 2019. “ultrasound-guided Subcostal Transversus Abdominis Plane Block with Liposomal Bupivacaine Compared to Bupivacaine Infiltration for Patients Undergoing Robotic-assisted and Laparoscopic Hysterectomy: A Prospective Randomized Study”. Journal of Pain Research. Informa UK Limited. doi:10.2147/jpr.s193872.

clinicaltrials.govStudy