Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06446960
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-01-30
Brief Title:
The Role of Peripheral Afferents in Modulating Post-stroke Central Pain
Sponsor:
Institut National de la Santé Et de la Recherche Médicale France
Organization:
Institut National de la Santé Et de la Recherche Médicale France
Study Overview
Official Title:
The Role of Peripheral Afferents in Modulating Post-stroke Central Pain
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APEDOC
Brief Summary:
Central post-stroke pain CPP is extremely difficult to relieve and responds very poorly to analgesics targeting neuropathic pain probably because the mechanisms underlying this pain remain poorly understood
Stroke pain is traditionally considered to be of central origin and related to changes in the spinal cord andor brain nociceptive systems However a recent study in a small cohort of patients has suggested that the peripheral nervous system PNS may have a role in the initiation and persistence of APD
The main objective of this prospective randomised controlled bicentric study Raymond Poincaré and Ambroise Paré in double blind and parallel groups against placebo 3 arms will be 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 20 mgml or levobupivacaine 125 mgml or placebo saline
Stroke pain is traditionally considered to be of central origin and related to changes in the spinal cord andor brain nociceptive systems However a recent study in a small cohort of patients has suggested that the peripheral nervous system PNS may have a role in the initiation and persistence of APD
The main objective of this prospective randomised controlled bicentric study Raymond Poincaré and Ambroise Paré in double blind and parallel groups against placebo 3 arms will be 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 20 mgml or levobupivacaine 125 mgml or placebo saline
Detailed Description:
The primary endpoint will be the change in neuropathic pain intensity assessed on an 11-point pain intensity scale 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 Secondary endpoints will include exertional pain pain quality relief clinical global impression pain assessment on a patient diary for a fortnight after each block and adverse events
Patients will be randomised to receive one of 3 study treatments lidocaine 2 levobupivacaine 125 mgml or placebo The treatment protocol will involve 2 perineural blocks performed 14 days apart Assessment will continue for up to 2 weeks after each block ie up to one month after the start of treatment An evaluation of pain will be carried out before the block and after each block at 45 minutes and at 5 hours and then daily by the patient on a self-evaluation booklet for the 14 days following each block
Randomisation will be centralised on a server from a list drawn up in advance by computer rogramme balanced by blocks of variable size Allocation between the 3 arms will be done according to a balanced 111 distribution Treatments will be numbered from 1 to n and allocated to patients in the chronological order of their inclusion in the trial
Patients will be randomised on the day of treatment using a centralised computerised randomisation procedure to receive one of the 3 study treatments lidocaine 20 mgml levobupivacaine 125 mgml or saline No matching by age or duration of pain is planned as randomisation usually results in groups matched at baseline on these criteria The treatment will be administered over two visits performed 14 days apart by a qualified anaesthetist using the peri-nervous route according to current ecommendations see above Only one randomisation will be performed at baseline so that a patient on active treatment cannot receive placebo at a later date and vice versa see figure 1
The investigators plan to randomise 10 patients per group and a total of 30 patients to achieve 90 power with a two sided α risk005 Given the estimated premature discontinuation rate the investigators consider it necessary to include 12 patients per group for a total of 36 patients
This study opens the way to new therapeutic avenues for these patients who often fail all treatments
Patients will be randomised to receive one of 3 study treatments lidocaine 2 levobupivacaine 125 mgml or placebo The treatment protocol will involve 2 perineural blocks performed 14 days apart Assessment will continue for up to 2 weeks after each block ie up to one month after the start of treatment An evaluation of pain will be carried out before the block and after each block at 45 minutes and at 5 hours and then daily by the patient on a self-evaluation booklet for the 14 days following each block
Randomisation will be centralised on a server from a list drawn up in advance by computer rogramme balanced by blocks of variable size Allocation between the 3 arms will be done according to a balanced 111 distribution Treatments will be numbered from 1 to n and allocated to patients in the chronological order of their inclusion in the trial
Patients will be randomised on the day of treatment using a centralised computerised randomisation procedure to receive one of the 3 study treatments lidocaine 20 mgml levobupivacaine 125 mgml or saline No matching by age or duration of pain is planned as randomisation usually results in groups matched at baseline on these criteria The treatment will be administered over two visits performed 14 days apart by a qualified anaesthetist using the peri-nervous route according to current ecommendations see above Only one randomisation will be performed at baseline so that a patient on active treatment cannot receive placebo at a later date and vice versa see figure 1
The investigators plan to randomise 10 patients per group and a total of 30 patients to achieve 90 power with a two sided α risk005 Given the estimated premature discontinuation rate the investigators consider it necessary to include 12 patients per group for a total of 36 patients
This study opens the way to new therapeutic avenues for these patients who often fail all treatments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-504676-17-00 | OTHER | N EU CT | None |