Pain-Selective Epidural Analgesia for Labor Mobility
Official title: Pain Selective Anesthesia for Labor Mobility (PSALM Study): a Randomized Controlled Trial of Combined Lidocaine - Chlorprocaine for Labor Epidural Analgesia
Run by Hadassah Medical Organization · NCT06302257 · Data updated 2026-11-12
This study tests a new epidural approach to block only labor pain so mothers can ambulate and push normally during labor.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 40 Years |
| Sex | Women only |
| Enrollment | 303 (estimated) |
| Sponsor | Hadassah Medical Organization Academic / other |
| Locations | 3 sites (Jerusalem and 2 other locations) |
| Status | Recruiting |
| Started | March 12, 2024 |
| Main results expected | March 1, 2028 |
| Study ends | March 1, 2028 |
| Registry record updated | September 25, 2026 |
| Trial ID | NCT06302257 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant women in early active labor (cervical dilation <5 cm), nulliparous, aged 18-40, singleton vertex pregnancies, BMI <110 kg, gestational age >36 weeks, ASA II, at Hadassah-associated centers.
✕Probably not a fit
Patients who do not respond to the specific nociceptor-targeted approach or who have contraindications to local anesthetics may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled trial evaluates a novel method for pain-selective local anesthesia during labor using TRPV1-targeted delivery to nociceptors. By combining membrane-impermeable anesthetics with TRPV1 agonists, the approach aims to block pain fibers while avoiding motor, sensory, or blood pressure side effects. The intervention arms include chlorprocaine, lidocaine, and a lidocaine-chlorprocaine combination, delivered via an epidural route in women in early active labor. Eligible participants are nulliparous, 18-40 years old, with singleton, vertex pregnancies at 36 weeks or more, and specific health criteria. The trial seeks to determine whether this method provides effective pain relief with preserved ability to ambulate and push.
Why it matters
Potential benefit: If successful, patients could experience effective labor pain relief without motor weakness or hypotension, supporting mobility and pushing.
How similar studies have gone: Previous preclinical and early-phase work on nociceptor-selective anesthesia suggests potential, but this approach is novel in the labor epidural context and is being tested in humans.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Nulliparity * Early active labor, cervical dilatation less than 5 cm, * Age between 18 to 40, * American Society of Anesthesiologists physical status class II * Body weight less than 110 kg, * Gestational age greater than 36 completed weeks, * Singleton pregnancy * Vertex presentation. Exclusion Criteria: * Narcotic administration in the previous 3 hours * Previous uterine surgery * Pre-eclampsia * Inability to adequately understand the consent
Where it's running
-
Hadassah Hebrew University Medical Center, POB 12000
Jerusalem, Israel Recruiting -
Hadassah Mount Scopus
Jerusalem, Israel Recruiting -
Kaplan Medical Center
Rehovot, Israel Not yet recruiting
Study contacts
- Study coordinator: Yehuda Ginosar, MS
- Email: ginosar@mail.huji.ac.il
- Phone: 0507874388
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.