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RecruitingAccepts healthy volunteersPhase 4

ED90 of Bupivacaine After Lidocaine Test Dose With DPE and EPL

Brigham and Women's Hospital · NCT06146842

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Any age listed · Women only
Healthy volunteers
Accepted
Study type
Interventional · Phase 4
Target enrollment
120
US sites recruiting
1
Study start
December 1, 2023
Record last updated
July 13, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

The primary objective of our study is to use a biased coin up-down allocation methodology to estimate the dose of bupivacaine required after the lidocaine test dose to achieve initial effective comfort in 90% of patients (post test-dose ED90) via the epidural (DPE or EPL) technique in women undergoing labor induction or augmentation; the investigators hypothesize that the investigators will be able to determine the post test-dose ED90 of bupivacaine for each technique with adequate precision to inform the optimal doses to study in a subsequent randomized trial comparing the analgesic effects of DPE vs. EPL. The investigators also hypothesize that the post test-dose ED90 of bupivacaine is lower with a DPE technique than with a conventional epidural technique.

Being studied: Bupivacaine Hydrochloride

Conditions: Labor Pain

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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 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

  • 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 (e.g., thrombocytopenia, antiplatelet meds).
  • History of hypersensitivity or idiosyncratic reaction to an amide local anesthetic agent
  • Evidence of anticipated fetal complications (i.e., fetal anomalies, IUGR (Intrauterine Growth Restriction), oligohydramnios, polyhydramnios)

Recruiting US locations

  • Brigham and Women's Hospital

    Boston, MA 02115

    Site contact: Ayumi Maeda, MD PhD · 617-732-8216 · amaeda@bwh.harvard.edu

Study contacts (from the official record)

  • Lawrence Tsen, MD · 617-732-8216 · ltsen@bwh.harvard.edu
  • Ayumi Maeda, MD · amaeda@bwh.harvard.edu
All healthy volunteers studies in Massachusetts →
ED90 of Bupivacaine After Lidocaine Test Dose With DPE and EPL (NCT06146842) | Bored Studies