Determining the effective dose of bupivacaine for labor pain relief
A Trial to Determine the Optimal Bupivacaine Dose for Initiation of Labor Epidural Pain Relief with a Lidocaine Test Dose
This study is testing how much bupivacaine is needed to effectively relieve pain for women in labor after they receive a test dose of lidocaine.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Sex | Female |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06146842 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include pregnant women at term with no major co-morbidities who desire epidural labor analgesia.
Not a fit: Patients with significant medical conditions or contraindications to epidural techniques will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could optimize pain management during labor, leading to improved comfort for patients.
How similar studies have performed: Other studies have successfully utilized similar methodologies to determine effective analgesic doses, suggesting this approach is promising.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.