Actively Recruiting
A Trial to Determine the Optimal Bupivacaine Dose for Initiation of Labor Epidural Pain Relief with a Lidocaine Test Dose
Led by Brigham and Women's Hospital · Updated on 2025-02-10
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the optimal dose of bupivacaine needed after a lidocaine test dose to provide effective pain relief for 90% of women undergoing labor induction or augmentation. This Phase 4 randomized controlled trial compares two epidural techniques: dural puncture epidural (DPE) and traditional epidural (EPL). The study aims to determine the post test-dose ED90 of bupivacaine for each technique to guide dosing in future trials. Participants will be randomly assigned to receive an epidural catheter using either the DPE or EPL method. The first patient in each group will receive 25 mg of bupivacaine, with subsequent doses adjusted based on the previous patient's pain response following a biased coin up-down method. Dose adjustments occur in 2.5 mg increments, increasing if pain relief is insufficient and decreasing or maintaining if effective, aiming to achieve a pain score below 3 on the Numerical Rating Scale (NRS) within 30 minutes. During the study, participants will be monitored for pain relief using the NRS at 30 minutes after dosing. Researchers will assess the dose required to achieve effective comfort and compare the two epidural techniques. Safety and response data will be collected throughout the intervention. The total duration of participation depends on labor progress and treatment needs, with ongoing evaluation of pain control effectiveness.
CONDITIONS
Brief Title
ED90 of Bupivacaine After Lidocaine Test Dose with DPE and EPL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 at time of epidural labor analgesia request
You will not qualify if you...
- Current or historical evidence of clinically significant disease or condition, including diseases of pregnancy such as preeclampsia or gestational diabetes
- Any contraindication to epidural technique, including thrombocytopenia or use of antiplatelet medications
- History of hypersensitivity or unusual reaction to amide local anesthetic agents
- Evidence of anticipated fetal complications such as fetal anomalies, intrauterine growth restriction, oligohydramnios, or polyhydramnios
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of labor until delivery
Participants receive an epidural catheter via either the dural puncture epidural (DPE) technique or the traditional epidural labor (EPL) technique and are administered doses of bupivacaine to manage labor pain. Doses are adjusted sequentially based on pain relief response.
1 treatment visit during labor
Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
L
Lawrence Tsen, MD
A
Ayumi Maeda, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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