Status:
RECRUITING
ED90 of Bupivacaine After Lidocaine Test Dose with DPE and EPL
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Labor Pain
Eligibility:
FEMALE
Phase:
PHASE4
Brief Summary
The primary objective of our study is to use a biased coin up-down allocation methodology to estimate the dose of bupivacaine required after the lidocaine test dose to achieve initial effective comfor...
Detailed Description
The investigators will be conducting a randomized controlled trial with patients randomized into either an EPL or a DPE group. For the first subject in the DPE and EPL techniques, the initial dose of ...
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 than 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 (e.g., thrombocytopenia, antiplatelet meds).
- History of hypersensitivity or idiosyncratic reaction to an amide local anesthetic agent
- Evidence of anticipated fetal complications (i.e., fetal anomalies, IUGR (Intrauterine Growth Restriction), oligohydramnios, polyhydramnios)
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06146842
Start Date
December 1 2023
End Date
January 31 2026
Last Update
February 10 2025
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115