Epidural Bupivacaine with Lidocaine for Labor Pain

This study is looking for women aged 18 to 50 who are in labor and want an epidural for pain relief. You would need to be 37-42 weeks pregnant with a single baby, have no major health problems, and be less than 5 cm dilated with a pain score of 5 or higher. The study is testing different doses of bupivacaine hydrochloride, a medication used in epidurals, after you receive a standard lidocaine "test dose." The goal is to find the dose of bupivacaine that effectively relieves pain for 90% of patients. The study is currently recruiting 120 participants.

Study design
This interventional study plans to enroll 120 women. It uses a special method called a biased coin up-down allocation to determine bupivacaine doses.
What's involved
You would receive doses of bupivacaine as part of your epidural. Your pain level will be measured 30 minutes after the epidural is started.
Compensation
Not stated in the trial record.
Follow-up
Your pain will be measured at 30 minutes after the epidural is initiated.

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NCT05543694

ED90 of Epidural Bupivacaine With Lidocaine for the Initiation of Labor Analgesia

Recruiting
PHASE4Ages 18–50InterventionalTreatment
Brigham and Women's Hospital
~120 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:Bupivacaine Hydrochloride

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Verbal Numerical Pain Rating Score
Measured over 30 minutes
Labor Pain
Analgesia
1 sites across 1 states
Massachusetts1

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Eligibility criteria

Inclusion

Parturient with no major co-morbidities
Singleton, vertex gestation at term (37-42 weeks)
Less than or equal to 5 cm dilation
Desire to receive epidural labor analgesia
Numerical Rating Scale greater or equal to 5 (NRS 0-10, where 0 = no pain, and 10 = worst pain imaginable), at time of epidural labor analgesia request.

Exclusion

Current or historical evidence of clinically significant disease or condition, including diseases of pregnancy (i.e preeclampsia, gestational diabetes)
Any contraindication to the administration of an epidural technique
History of hypersensitivity or idiosyncratic reaction to an amide local anesthetic agent
Current or historical evidence of a disease which may result in the risk of a cesarean delivery (i.e. history of uterine rupture). NB: Exception-trial of labor after cesarean delivery (TOLAC) will be eligible.
Evidence of anticipated fetal anomalies
  • Verbal Numerical Pain Rating Score30 minutes

    (0-10, with higher scores meaning more pain); goal with analgesia is \< 3/10