NCT05543694 ED90 of Epidural Bupivacaine With Lidocaine for the Initiation of Labor Analgesia
| NCT ID | NCT05543694 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Brigham and Women's Hospital |
| Condition | Labor Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2022-10-01 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 120 participants in total. It began in 2022-10-01 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 after receiving a lidocaine "test dose"
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05543694 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Labor Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05543694 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05543694 currently recruiting?
Yes, NCT05543694 is actively recruiting participants. Contact the research team at ltsen@bwh.harvard.edu for enrollment information.
Where is the NCT05543694 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05543694 clinical trial?
NCT05543694 is sponsored by Brigham and Women's Hospital. The trial plans to enroll 120 participants.