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Local Anesthetic
Bupivacaine Hydrochloride for Labor Pain
Phase 4
Waitlist Available
Led By Lawrence Tsen, MD
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
Parturient with no major co-morbidities
Singleton, vertex gestation at term (37-42 weeks)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes
Awards & highlights
Study Summary
This study is evaluating whether a specific dose of a local anesthetic may help reduce pain for women during labor.
Eligible Conditions
- Labor Pain
- Pain relief
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Verbal Numerical Rating Score (0-10, with higher scores meaning more pain); goal with analgesia is < 3/10
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 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) 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
FDA approved
Find a Location
Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,600 Previous Clinical Trials
11,462,825 Total Patients Enrolled
3 Trials studying Labor Pain
360 Patients Enrolled for Labor Pain
Lawrence Tsen, MDPrincipal InvestigatorAssociate Professor in Anesthesiology, Harvard Medical School
1 Previous Clinical Trials
234 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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