Optimal Bupivacaine Dose for Initiation of Labor Epidural Techniques

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-25

Study Completion Date

2022-03-23

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Labor Pain Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial Using Biased Coin Design to Determine Effective Dose for 90% (ED90) of Subjects

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

The biased-coin allocation after each successful response will be implemented by flipping a virtual biased coin (10% vs. 90% probability of randomizing the next patient to the lower vs. same dose than received by the last patient with the same epidural technique) using R statistical software (R Foundation for Statistical Computing, Vienna, Austria). Care Provider (Clinical Anesthesiologist) will administer the identified dose, then summon blinded observer.

Study Groups

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Dural Puncture Epidural Technique

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 Type EXPERIMENTAL

Bupivacaine Hydrochloride

Intervention Type DRUG

Local Anesthetic Agent

Epidural Technique

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.

Group Type ACTIVE_COMPARATOR

Bupivacaine Hydrochloride

Intervention Type DRUG

Local Anesthetic Agent

Interventions

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Bupivacaine Hydrochloride

Local Anesthetic Agent

Intervention Type DRUG

Other Intervention Names

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Marcaine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes