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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

Drug Has Already Been Approved

Pivotal Trial

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

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

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.

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

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 2Eligibility criteria met