Optimal Bupivacaine Dose for Initiation of Labor Epidural Techniques

Brigham and Women's Hospital100 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

100

Conditions

Labor Pain Analgesia

Interventions

Bupivacaine HydrochlorideDRUG

Local Anesthetic Agent

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Verbal Numerical Rating Score (0-10, with higher scores meaning more pain); goal with analgesia is < 3/10

Pain Score (0=no pain, 10= worst pain imaginable)

Time frame: 30 minutes

Data from ClinicalTrials.gov

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