Trial · NCT06302257
Pain Selective Anesthesia for Labor Mobility (PSALM Study): a Randomized Controlled Trial of Combined Lidocaine - Chlorprocaine for Labor Epidural Analgesia
NCT06302257, Phase 4, Recruiting, Hadassah Medical Organization
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pain Selective Anesthesia for Labor Mobility (PSALM Study): a Randomized Controlled Trial of Combined Lidocaine - Chlorprocaine for Labor Epidural Analgesia. Trials, record NCT06302257. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06302257
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pain Selective Anesthesia for Labor Mobility (PSALM Study): a Randomized Controlled Trial of Combined Lidocaine - Chlorprocaine for Labor Epidural Analgesia
- NCT number
- NCT06302257
- Status
- Recruiting
- Phases
- Phase 4
- Enrollment
- 303 participants, estimated
- Lead sponsor
- Hadassah Medical Organization
- Conditions
- Labor Pain
- Interventions
- Chlorprocaine, Lidocaine, Lidocaine-chlorprocaine combination
- First posted
- 2024-03-08
- Last updated
- 2026-09-25
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | VAS pain score / modified Bromage motor block score | 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). | 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. |
| Secondary | 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). | Thermal imaging of the feet and hands using a FlirC3 thermal camera. Measuring the proximal and distal temperatures. |
| Secondary | 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. | Using an ice cube to test the patient perception of cold sensation on the L2 and T10. Both right and left side perception will be recorded. Recorded from three options - perception of cold, perception of touch, or no perception. |
| Secondary | Anesthesia requirement. | Measured at the end of delivery | From the epidural PCEA pump we will record the frequency of epidural PCA self- administered doses, the need for any rescue supplemental boluses, the numbers of failed attempted self-administered boluses (requests were not allowed because the button was pressed within the 10-minute lockout time), the total dose administered, and the total dose / time of labor. For the first 30 minutes after placing the epidural catheter, up until the first epidural top-up |
| Secondary | Pushing ability in labor. | Measured at the end of delivery | This will be assessed by the midwife, who is blinded to the study group. As occasionally the delivery of the fetus is impaired by the large size or malrotation of the fetus, this score is assessed not on the successful vaginal delivery, but rather on the strength of pushing and the ability to sense the need to push. * In the second stage of labor: rate the ability to sense the urge to push: 0-100 (0= complete inability and 100=best imaginable). * In the second stage of labor: rate the ability push (strength): 0-100 (0= complete inability and 100=best imaginable). For the first 30 minutes after placing the epidural catheter, up until the first epidural top-up |
| Secondary | 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). | Assessment of maternal blood pressure will be measured after placing the epidural catheter. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06302257
GET https://conductscience.org/api/trials/v1/NCT06302257/registered