Optimal Bupivacaine Dose for Initiation of Labor Epidural Techniques

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

1. Parturient with no major co-morbidities

2. Singleton, vertex gestation at term (38-42 weeks)

3. Less than 5 cm dilation

4. Desire to receive epidural labor analgesia

5. Numerical Rating Scale > 5 (NRS 0-10, where 0 = no pain, and 10 = worst pain imaginable), at time of epidural labor analgesia request.

Exclusion Criteria:

1. Current or historical evidence of clinically significant disease or condition, including diseases of pregnancy (i.e preeclampsia, gestational diabetes)

2. Any contraindication to the administration of an epidural technique

3. History of hypersensitivity or idiosyncratic reaction to an amide local anesthetic agent

4. Current or historical evidence of a disease which may result in the risk of a cesarean delivery (i.e. vaginal birth after cesarean delivery, history of uterine rupture)

5. Evidence of anticipated fetal anomalies