Determining the effective dose of bupivacaine for labor pain relief

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to estimate the effective dose of bupivacaine needed for pain relief in women undergoing labor induction or augmentation after a lidocaine test dose. It employs a randomized controlled trial design with participants assigned to either the DPE or EPL technique. The initial dose of bupivacaine is set at 25 mg, and subsequent doses are adjusted based on the responses of previous subjects using a biased coin up-down allocation method. The goal is to achieve a pain score of less than 3 on a numerical rating scale within 30 minutes of administration.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Parturient with no major co-morbidities
2. Singleton, vertex gestation at term (37-42 weeks)
3. Less than or equal to 5 cm dilation
4. Desire to receive epidural labor analgesia
5. 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 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 (e.g., thrombocytopenia, antiplatelet meds).
3. History of hypersensitivity or idiosyncratic reaction to an amide local anesthetic agent
4. Evidence of anticipated fetal complications (i.e., fetal anomalies, IUGR (Intrauterine Growth Restriction), oligohydramnios, polyhydramnios)

Where it's running

• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Lawrence Tsen, MD
• Email: ltsen@bwh.harvard.edu
• Phone: 617-732-8216

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• TENS for pain relief during active labor

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• PIEB versus CEI for epidural labor pain relief

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.