Trial · NCT06446960
The Role of Peripheral Afferents in Modulating Post-stroke Central Pain
NCT06446960, Phase 3, Completed, Institut National de la Santé Et de la Recherche Médicale, France
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Role of Peripheral Afferents in Modulating Post-stroke Central Pain. Trials, record NCT06446960. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06446960
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Role of Peripheral Afferents in Modulating Post-stroke Central Pain
- NCT number
- NCT06446960
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 33 participants, actual
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
- Conditions
- Stroke
- Interventions
- Lidocaine 20mg/ml, Levobupivacaine Hydrochloride 1.25 MG/ML, Sodium Chloride 0.9% Inj
- First posted
- 2024-06-06
- Last updated
- 2026-10-19
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To evaluate the efficacy of two peripheral nerve blocks performed 14 days apart on spontaneous neuropathic pain after stroke. The active treatments used for the blocks will be either lidocaine 20mg/ml or levobupivacaine 1.25mg/ml or placebo (saline) | 24 months | The evolution in neuropathic pain intensity assessed on an 11-point pain intensity scale (0 = no pain: 10: maximum imaginable pain), expressed as a difference in pain intensity between the value obtained before each block and that obtained 45 minutes after, corresponding to the maximum expected effect. The values obtained before and after each block will first be analysed individually and then combined for the two successive blocks for each patient and the comparison will be between the three treatment arms, lidocaine 20mg/ml, levobupivacaine 1.25mg/ml or placebo Rationale for the choice of the main criterion : Pain intensity will be assessed on a numerical scale that corresponds to the usual validated measurement criterion and the choice of 45 minutes corresponds to the maximum effect of local anaesthetics |
| Secondary | - To evaluate the time course and duration of the effectiveness of the nerve blocks on spontaneous pain on a pain intensity scale completed daily by the patient on a self-evaluation booklet up to 14 days after each block. | 24 months | \- Comparison of the duration (in days) of efficacy of lidocaine 20 mg/ml levobupivacaine 1.25 mg/ml and placebo blocks on spontaneous and exertional pain assessed by an 11-point pain intensity scale (0 to 10) completed daily by the patient on a self-report diary, up to 14 days after each block. |
| Secondary | - Evaluate the effectiveness of blocks on exercise pain | 24 months | \- Comparison of the efficacy of levobupicacaine 1.25 mg/ml, lidocaine 20 mg/ml and placebo on spontaneous and exertional pain assessed by an 11-point pain intensity scale (0 to 10) at 45 minutes and then at 5 hours after the block and then daily on a self-evaluation booklet, up to 14 days after each block |
| Secondary | - Directly compare the efficacy of active blocks, i.e. lidocaine and levobupivacaine, on spontaneous and provoked pain (allodynia) | 24 months | * Comparison of the efficacy of lidocaine, levobupivacaine and placebo blocks on the intensity of rubbing pain if present (dynamic mechanical allodynia) assessed before treatment with a brush and then at 45 minutes and at 5 hours after each block. * Comparison of the efficacy of lidocaine, levobupivacaine and placebo blocks on spontaneous and provoked pain area (mechanical allodynia if present) assessed by a tracing (and then plotted on a graph allowing measurement of area in cm2) before treatment and then at 45 minutes and at 5 hours after each block using a method used in our previous studies |
| Secondary | - Evaluate the effectiveness of each block on provoked pain (mechanical allodynia), mechanical, hot and cold pain thresholds and pain area | 24 months | \- Comparison of the efficacy of lidocaine, levobupivacaine and placebo blocks on mechanical pain and detection thresholds assessed by Semmes Weinstein monofilaments (calibrated from 0.057 g to 300 g) as well as on thermal pain and detection thresholds assessed by a thermotest before the treatment and at 45 minutes and at 5 hours after each block |
| Secondary | - Evaluate the effectiveness of each block on the dimensions of neuropathic pain assessed by the NPSI questionnaire | 24 months | \- Comparison of the efficacy of lidocaine, levobupivacaine and placebo blocks on dimensions of neuropathic pain assessed by the NPSI questionnaire before treatment and at 45 minutes, and at 5 hours and 2 weeks after each block |
| Secondary | - To evaluate the effectiveness of the blocks on the overall clinical impression, the percentage of relief as well as the satisfaction with the treatment | 24 months | Evaluation of adverse effects of lidocaine, levobupivacaine and placebo blocks after the blocks and up to 14 days after each block. * Efficacy of lidocaine, levobupivacaine and placebo blocks on patient (PGIC) and examiner (CGIC) clinical global impression at 45 minutes, and at 5 hours and 2 weeks after each block. * Proportion of responders to lidocaine, levobupivicaine and placebo treatments assessed at 45 minutes, ad at 5 hours and 2 weeks after each block. |
| Secondary | - Assessing the adverse effects of each treatment | 24 months | \- Evaluation of adverse effects of lidocaine, levobupivacaine and placebo blocks after the blocks and up to 14 days after each block |
| Secondary | - Assessing the maintenance of blinding by a blinding questionnaire at the end of the study | 24 months | \- Blinding assessment by a blinding questionnaire at the end of the study for each patient |
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/NCT06446960
GET https://conductscience.org/api/trials/v1/NCT06446960/registered