Status:
COMPLETED
Optimal Bupivacaine Dose for Initiation of Labor Epidural Techniques
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Labor Pain
Analgesia
Eligibility:
FEMALE
18-50 years
Phase:
PHASE4
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.
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) vi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 23 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04814537
Start Date
February 25 2021
End Date
March 23 2022
Last Update
August 4 2022
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115