Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Analgesia
  • Labor Pain
Type
Interventional
Phase
Phase 4
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized Controlled Trial Using Biased Coin Design to Determine Effective Dose for 90% (ED90) of SubjectsMasking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: 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.Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 50 years
Gender
Only males

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 hypoth...

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.

Tracking Information

NCT #
NCT04814537
Collaborators
Not Provided
Investigators
Principal Investigator: Lawrence Tsen, MD Associate Professor in Anesthesiology, Harvard Medical School
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