Recruiting

Bupivacaine with Lidocaine

Sponsor:

Brigham and Women's Hospital

Code:

NCT05543694

Conditions

Labor Pain

Analgesia

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Bupivacaine Hydrochloride

Study Details

Brief summary:

To estimate the dose of bupivacaine required to achieve initial effective comfort in 90% of patients (ED90) via the epidural (DPE or EPL) technique in women undergoing labor after receiving a lidocaine "test dose"

Conditions

Labor Pain

Analgesia

Study ID

NCT05543694

Start date

Oct 1, 2022

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: 18 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dural Puncture Epidural Technique

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.

active comparator: Epidural Technique

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.

Interventions

Bupivacaine Hydrochloride

Subjects will receive a dose of bupivacaine as described in the arm section of this trial

Primary outcome measure

  • Verbal Numerical Pain Rating Score [ Time Frame: 30 minutes ]

Central Contacts and Locations

Central contacts

Lawrence C Tsen, MD

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

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Lawrence C Tsen, MD

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

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

  • Dural puncture epidural
  • Neuraxial Analgesia
  • Bupivacaine
  • Local Anesthetic

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.