ED90 of Epidural Bupivacaine With Lidocaine for the Initiation of Labor Analgesia
Brigham and Women's Hospital · NCT05543694
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
- Ages 18–50 · Women only
- Healthy volunteers
- Accepted
- Study type
- Interventional · Phase 4
- Target enrollment
- 120
- US sites recruiting
- 1
- Study start
- October 1, 2022
- Record last updated
- July 13, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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 after receiving a lidocaine "test dose"
Being studied: Bupivacaine Hydrochloride
Conditions: Labor Pain; Analgesia
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 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
Recruiting US locations
Brigham and Women's Hospital
Boston, MA 02115
Site contact: Lawrence C Tsen, MD · 617-732-8216 · ltsen@zeus.bwh.harvard.edu
Study contacts (from the official record)
- Lawrence C Tsen, MD · 617-732-8216 · ltsen@bwh.harvard.edu
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