Recruiting

Bupivacaine

Sponsor:

Brigham and Women's Hospital

Code:

NCT06146842

Conditions

Labor Pain

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

Interventions

Bupivacaine Hydrochloride

Study Details

Brief summary:

The primary objective of our study is to use a biased coin up-down allocation methodology to estimate the dose of bupivacaine required after the lidocaine test dose to achieve initial effective comfort in 90% of patients (post test-dose ED90) via the epidural (DPE or EPL) technique in women undergoing labor induction or augmentation; the investigators hypothesize that the investigators will be able to determine the post test-dose ED90 of bupivacaine for each technique with adequate precision to inform the optimal doses to study in a subsequent randomized trial comparing the analgesic effects of DPE vs. EPL. The investigators also hypothesize that the post test-dose ED90 of bupivacaine is lower with a DPE technique than with a conventional epidural technique.

Conditions

Labor Pain

Study ID

NCT06146842

Start date

Dec 1, 2023

Status verified date

Jul, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

1. Current or historical evidence of clinically significant disease or condition, including diseases of pregnancy (i.e., preeclampsia, gestational diabetes)
2. Any contraindication to the administration of an epidural technique (e.g., thrombocytopenia, antiplatelet meds).
3. History of hypersensitivity or idiosyncratic reaction to an amide local anesthetic agent
4. Evidence of anticipated fetal complications (i.e., fetal anomalies, IUGR (Intrauterine Growth Restriction), oligohydramnios, polyhydramnios)

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: DPE Group

Subjects will receive an epidural catheter via a dural puncture epidural technique.

active comparator: EPL Group

Subjects will receive an epidural catheter via a traditional epidural technique.

Interventions

Bupivacaine Hydrochloride

Each subject will receive allocated dose of bupivacaine

Primary outcome measure

  • NRS <3 at 30 min [ Time Frame: 30 minutes after time 0. ]

Central Contacts and Locations

Central contacts

Lawrence Tsen, MD

617-732-8216ltsen@bwh.harvard.edu

Ayumi Maeda, MD

amaeda@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Ayumi Maeda, MD PhD

617-732-8216amaeda@bwh.harvard.edu

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-07-13.