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

NCT06302257 | Recruiting Phase 4

• 1 other identifier: 0532-23-HMO
• Study Type: interventional
• Target: 303
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Labor Pain

Keywords

Pain; Labor; Analgesia; Local anesthetic; Epidural; Randomized controlled trial; Lidocaine; Chloroprocaine; Visual analogue scale

Outcome Measures

Primary Outcomes (1)

• VAS pain score / modified Bromage motor block score

  Pain (VAS 1-100) where the anchors of the VAS score are 1=no pain, 100=worst imaginable pain, until the first epidural top-up. We use 1 as the lowest anchor for no pain because 0 is not divisible mathematically. Modified Bromage motor block score where the scores are determined as follows: 1 = unable to move legs or feet; 2 = unable to flex knees, free movement of feet; 3 = just able to flex knees with free movement of feet; 4 = free movement of legs and feet; 5 = able to perform partial knee-bend movements while standing. VAS and Bromage will also be reported individually.

  At baseline and every 10 minutes for the first 30 minutes and then every 15 minutes there on after for 165 minutes (or until delivery).

Secondary Outcomes (5)

• Segmental sympathectomy

  At baseline and every 10 minutes for the first 30 minutes and then every 15 minutes there on after for 165 minutes (or until delivery).

• Sensory assessment to cold sensation

  At baseline and every 10 minutes for the first 30 minutes and then every 15 minutes there on after for 165 minutes.

• Anesthesia requirement.

  Measured at the end of delivery

• Pushing ability in labor.

  Measured at the end of delivery

• Maternal Blood pressure

  At baseline and every 10 minutes for the first 30 minutes and then every 15 minutes there on after for 165 minutes (or until delivery).

Study Arms (3)

lidocaine alone

ACTIVE COMPARATOR

Bolus: 20mL 0.27% lidocaine (based on our Stage 1a ED50-MLAC data), administered as incremental test dose over 5 minutes, plus 100mcg fentanyl. Maintenance: 100mL bags of lidocaine 0.27% + 2mcg/mL fentanyl, administered as PCEA using the following protocol: 5mL continuous dose, 10mL patient bolus dose, 10min lockout time, 50mL total dose per hour).

Drug: Lidocaine

Chlorprocaine only

ACTIVE COMPARATOR

Bolus: 20mL 0.28% lidocaine (based on our Stage 1a ED50-MLAC data), administered as incremental test dose over 5 minutes, plus 100mcg fentanyl. Maintenance: 100mL bags of chloroprocaine 0.28% + 2mcg/mL fentanyl, administered as PCEA using the following protocol: 5mL continuous dose, 10mL patient bolus dose, 10min lockout time, 50mL total dose per hour).

Drug: Chlorprocaine

Lidocaine-chlorprocaine combination

EXPERIMENTAL

Bolus: 10mL 0.1% lidocaine + 10mL 0.1% chloroprocaine (based on our Stage 1a ED50-MLAC data), administered as an incremental test dose over 5 minutes, plus 100mcg fentanyl. Maintenance: 100mL bags of 0.1% lidocaine + 0.1% chloroprocaine + 2mcg/mL fentanyl, administered as PCEA using the following protocol: 5mL continuous dose, 10mL patient bolus dose, 10min lockout time, 50mL total dose per hour).

Drug: Lidocaine-chlorprocaine combination

Interventions

Chlorprocaine DRUG

Study participants will receive chloroprocaine alone, together with standard epidural fentanyl (2mcg/mL in the epidural mixture).

Chlorprocaine only

Lidocaine DRUG

Study participants will receive lidocaine alone - together with standard epidural fentanyl (2mcg/mL in the epidural mixture).

lidocaine alone

Lidocaine-chlorprocaine combination DRUG

study participants randomized to this study arm will receive a a 50:50 mixture of lidocaine and chloroprocaine (based on the ED50s of each drug from Stage 1A and on the synergistic interactions from Stage 1B) - together with standard epidural fentanyl (2mcg/mL in the epidural mixture).

Lidocaine-chlorprocaine combination

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Only women in labor
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Narcotic administration in the previous 3 hours
• Previous uterine surgery
• Pre-eclampsia
• Inability to adequately understand the consent

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (3)

Hadassah Hebrew University Medical Center, POB 12000

Jerusalem, 91120, Israel

RECRUITING

Hadassah Mount Scopus

Jerusalem, 9765422, Israel

RECRUITING

Kaplan Medical Center

Rehovot, Israel

NOT YET RECRUITING

MeSH Terms

Conditions

Labor Pain; Pain; Agnosia

Interventions

chloroprocaine; Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Yehuda Ginosar, MS

CONTACT

0507874388; ginosar@mail.huji.ac.il

Atara Davis

CONTACT

+972533321329; ataratdavis@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, Hebrew University, Director, Obstetric Anesthesia Unit and Director, Anesthesia Research Institute, Hadassah Ein Karem Medical Center, Jerusalem, Israel.

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 8, 2024
• Study Start: March 12, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The IPD will be shared at the time of the major publication.
• Access Criteria: It will be released as a supplementary file with the major publication.

Locations

IL (3)