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

RecruitingPhase 4Ages 18 Years - 40 YearsFemaleHadassah Medical Organization
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In plain words

What the trial is, and whether it could suit you

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 p

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Chlorprocaine
  • Lidocaine
  • Lidocaine-chlorprocaine combination
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Where

3 sites
Hadassah Hebrew University Medical Center, POB 12000
Jerusalem, Israel
Hadassah Mount Scopus
Jerusalem, Israel
Kaplan Medical Center
Rehovot, Israel
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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