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Bupivacaine for Endometriosis

Phase 4
Recruiting
Led By Xiaoming Guan, PhD, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18-65 years old
Be older than 18 years old
Must not have
Subjects younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up postoperative pain level documented at 0, 2 and 4 hours after surgery, then once a day for 7 days after surgery.
Awards & highlights

Summary

This trial aims to see if a nerve block using a specific medication can reduce pain and the need for opioid medication in women undergoing surgery for endometriosis. The study will involve injecting the medication or

Who is the study for?
This trial is for women of reproductive age who are undergoing robotic surgery to remove endometriosis. Participants must be able to rate their pain and keep track of any opioid painkillers they use after the operation.
What is being tested?
The study tests if injecting Bupivacaine, a numbing medication, near nerves affected by endometriosis surgery can reduce pain and need for opioids post-surgery compared to using saline, a placebo. Pain levels will be tracked for one week.
What are the potential side effects?
Bupivacaine may cause side effects like numbness beyond the targeted area, weakness, dizziness or nausea. Serious but rare side effects include heart or nerve problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am under 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~postoperative pain level documented at 0, 2 and 4 hours after surgery, then once a day for 7 days after surgery.
This trial's timeline: 3 weeks for screening, Varies for treatment, and postoperative pain level documented at 0, 2 and 4 hours after surgery, then once a day for 7 days after surgery. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Postoperative pain
Secondary study objectives
Opioid use

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Investigative TreatmentExperimental Treatment1 Intervention
During the surgery, the investigative treatment group will have 5cc of diluted 0.25% Bupivacaine Hydrochloride injected into the superficial retroperitoneal area over the superior hypogastric nerve plexus.
Group II: PlaceboPlacebo Group1 Intervention
During the surgery, the placebo group will have 5cc of 0.9% normal saline injected into the superficial retroperitoneal area over the superior hypogastric nerve plexus.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine Hydrochloride
2020
Completed Phase 4
~1420

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,018 Previous Clinical Trials
6,031,369 Total Patients Enrolled
Xiaoming Guan, PhD, MDPrincipal InvestigatorDepartment Chair of Minimally Invasive Gynecologic Surgery
~40 spots leftby Apr 2025
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