ED90 of Epidural Bupivacaine for the Initiation of Labor Analgesia: A Randomized Biased Coin Sequential Allocation Trial With a Lidocaine Test Dose
Brigham and Women's Hospital
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"
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
Eligibility
- Age range
- 18–50 years
- Sex
- Female
- Healthy volunteers
- Yes
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 *…
Interventions
- DrugBupivacaine Hydrochloride
Subjects will receive a dose of bupivacaine as described in the arm section of this trial
Location
- Brigham and Women's HospitalBoston, Massachusetts