ED90 of Epidural Bupivacaine for the Initiation of Labor Analgesia: A Randomized Biased Coin Sequential Allocation Trial With a Lidocaine Test Dose
Overview
- Phase
- Phase 4
- Intervention
- Bupivacaine Hydrochloride
- Conditions
- Labor Pain
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Verbal Numerical Pain Rating Score
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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"
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. We will be conducting this study in women who receive a prior lidocaine "test dose" used in standard clinical practice
Investigators
Lawrence Ching Tsen
Associate Professor of Anesthesia
Brigham and Women's Hospital
Eligibility Criteria
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
Arms & Interventions
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.
Intervention: Bupivacaine Hydrochloride
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.
Intervention: Bupivacaine Hydrochloride
Outcomes
Primary Outcomes
Verbal Numerical Pain Rating Score
Time Frame: 30 minutes
(0-10, with higher scores meaning more pain); goal with analgesia is \< 3/10