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Local Anesthetic

Epidural Bupivacaine for Labor Pain

Phase 4

Recruiting

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Must not have

Any contraindication to the administration of an epidural technique

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 minutes

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial found that the ED90 of bupivacaine via the epidural technique is 3.65 milligrams in women undergoing labor after receiving a lidocaine test dose.

Who is the study for?

This trial is for women in labor at term (37-42 weeks) with a single baby positioned head down, who want epidural pain relief and have moderate to severe pain. They should be less than 5 cm dilated and without major health issues or conditions that increase the risk of cesarean delivery.

What is being tested?

The study aims to find the right dose of bupivacaine, an anesthetic drug given through the back into the epidural space, which can effectively reduce labor pain in 90% of patients after they've had a lidocaine test dose.

What are the potential side effects?

Possible side effects include discomfort at injection site, lower blood pressure, numbness or weakness in legs, headache from leakage of spinal fluid (rare), and rarely nerve damage.

Eligibility Criteria

Exclusion Criteria

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

Select...

I cannot have an epidural due to health reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain

Awards & Highlights

Pivotal Trial

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

Drug Has Already Been Approved

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

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Dural Puncture Epidural TechniqueExperimental Treatment1 Intervention

Laboring women receiving the Dural Puncture Epidural (DPE) Technique, after a lidocaine "test dose", with dose of Bupivacaine 0.25% diluted to 20 mL with isotonic sterile 0.9% saline. The first subject in the DPE group will receive an initial dose of bupivacaine 25 mg, with an endpoint being the achievement of an NRS \< 3 at 30 min. Subsequent patients are administered bupivacaine doses determined by the response of the previous subject, as per the biased coin method. The subsequent up and down interval doses are bupivacaine 2.5 mg (1 mL) increments, with an anticipated dose range from 20 mg to 40 mg.

Group II: Epidural TechniqueActive Control1 Intervention

Laboring women receiving the Conventional Epidural Technique (EPL), after receiving a lidocaine "test dose" with dose of Bupivacaine 0.25% diluted to 20 mL with isotonic sterile 0.9% saline. The first subject in the EPL group will receive an initial dose of bupivacaine 25 mg, with an endpoint being the achievement of an NRS \< 3 at 30 min. Subsequent patients are administered bupivacaine doses determined by the response of the previous subject, as per the biased coin method. The subsequent up and down interval doses are bupivacaine 2.5 mg (1 mL) increments, with an anticipated dose range from 20 mg to 40 mg.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bupivacaine Hydrochloride

2020

Completed Phase 4

~1420

0 / 1Eligibility criteria met