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Pain Selective Anesthesia for Labor Mobility (PSALM Study): a Randomized Controlled Trial of Combined Lidocaine - Chlorprocaine for Labor Epidural Analgesia

Study acronym: PSALM
StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 7 more changesShow less
    • Enrollment target: 60 to 303
    • Primary and study completion dates: Mar 1, 2025 to Mar 1, 2028
    • Study sites: 1 to 3
    • Start date changed from estimate of Mar 1, 2024 to Mar 12, 2024
    • Secondary endpoints: details revised at 5 of 5 entries
    • Study description expanded, about 579 words
    • Study title expanded, about 9 words
  2. Minor Secondary endpoints: details revised at 5 of 5 entriesv2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The current "gold standard" epidural analgesia for labor is associated with unwanted side effects, such as motor block (affecting ambulation and the ability to push) and sympathetic blockade (causing maternal hypotension). Here, using direct clinical application of preclinical findings, the investigator assess a novel method for prolonged pain-selective anesthesia during labor avoiding motor block, sympathetic block or other neural side effects. The approach is based on the pain-selective anesthesia the investigator developed in preclinical models, where the exclusive presence of TRPV1 channels on pain fibers (nociceptors) was exploited. The investigator used polarized, membrane-impermeable local anesthetics, together with the co-administration of direct TRPV1 agonists to open TRPV1 channels, so allowing these impermeable local anesthetics to gain selective access to nociceptors. Early preclinical studies used capsaicin as the TRPV1 agonist and QX-314 as the polarized local anesthetic, but neither of these drugs are appropriate for clinical use. Here the investigators use lidocaine as the TRPV1 activator and chloroprocaine as the polarized local anesthetic and hypothesize that this co-administration will elicit pain-selective (nociceptor-specific) anesthesia for labor without side effects. Positive findings in this study will be the first evidence in humans of pain-selective local anesthesia and will be the harbinger for future studies of systemic and regional administration of these drugs for pain-selective local anesthesia for chronic and other pain states.
Trial Details
NCT Number NCT06302257
Lead Sponsor Hadassah Medical Organization
Conditions
(from sponsor)
Labor Pain
Related terms Agnosia, Labor Pain, Pain
Enrollment 303 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov