Dose of bupivacaine needed for pain relief in labor with lidocaine test dose

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 interventional Phase 4 study uses a biased-coin up-down method to estimate the ED90 dose of bupivacaine for epidural analgesia during labor, comparing dural puncture epidural (DPE) and epidural plus local infiltration (EPL) techniques in women undergoing labor with induction or augmentation. Participants receive a lidocaine test dose per standard practice before epidural analgesia. Primary outcome is the dose of bupivacaine achieving initial comfort in 90% of patients with adequate precision. The study is conducted at Brigham and Women's Hospital, with no listed collaborators. Safety monitoring and standard obstetric analgesia protocols will be followed.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

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

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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.