CompletedPhase 4

Optimal Bupivacaine Dose for Initiation of Labor Epidural Techniques

United States100 participantsStarted 2021-02-25

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexFEMALE

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Verbal Numerical Rating Score (0-10, with higher scores meaning more pain); goal with analgesia is < 3/10

Timeframe: 30 minutes

Trial details

NCT IDNCT04814537

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-23

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