Optimal Bupivacaine Dose for Initiation of Labor Epidural Techniques

Phase 4

Completed

• Conditions: Labor Pain; Analgesia
• Interventions: Drug: Bupivacaine Hydrochloride

• Registration Number: NCT04814537
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

The primary objective of our study is to use a biased coin up-down allocation methodology 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 induction or augmentation; we hypothesize that we will be able to determine the ED90 of bupivacaine for each technique with adequate precision to inform the optimal doses.

Study Timeline

• Study Start: 2021-02-25
• Study First Submitted: 2021-03-22
• Study First Submitted QC: 2021-03-22
• Study First Posted: 2021-03-24
• Primary Completion: 2022-03-23
• Study Completion: 2022-03-23
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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 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
3. History of hypersensitivity or idiosyncratic reaction to an amide local anesthetic agent
4. 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.
5. Evidence of anticipated fetal anomalies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dural Puncture Epidural Technique	Bupivacaine Hydrochloride	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.
Epidural Technique	Bupivacaine Hydrochloride	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.

Primary Outcome Measures

Name	Time	Method
Verbal Numerical Rating Score (0-10, with higher scores meaning more pain); goal with analgesia is < 3/10	30 minutes	Pain Score (0=no pain, 10= worst pain imaginable)

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States