ED90 of Epidural Bupivacaine With Lidocaine for the Initiation of Labor Analgesia

Study Overview
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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 after receiving a lidocaine test dose

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. We will be conducting this study in women who receive a prior lidocaine test dose used in standard clinical practice

Official Title
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ED90 of Epidural Bupivacaine for the Initiation of Labor Analgesia: A Randomized Biased Coin Sequential Allocation Trial With a Lidocaine Test Dose

Conditions
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Labor Pain, Analgesia

Intervention / Treatment
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* Drug: Bupivacaine Hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial Using Biased Coin Design to Determine Effective Dose for 90% (ED90) of Subjects
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dural Puncture Epidural Technique<br>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. | Drug: Bupivacaine Hydrochloride<br>* Subjects will receive a dose of bupivacaine as described in the arm section of this trial<br>|
| Active Comparator: Epidural Technique<br>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. | Drug: Bupivacaine Hydrochloride<br>* Subjects will receive a dose of bupivacaine as described in the arm section of this trial<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verbal Numerical Pain Rating Score | (0-10, with higher scores meaning more pain); goal with analgesia is < 3/10 | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dural puncture epidural, Neuraxial Analgesia, Bupivacaine, Local Anesthetic