Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06602349
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
EFFICACY of USUAL MANAGEMENT of CHRONIC IDIOPATHIC ANO-PERINEAL PAIN by USING LOCAL ANESTHETIC INFILTRATION
Sponsor:
None
Organization:
None
Study Overview
Official Title:
EFFICACY of USUAL MANAGEMENT of CHRONIC IDIOPATHIC ANO-PERINEAL PAIN by USING LOCAL ANESTHETIC INFILTRATION a RANDOMIZED DOUBLE-BLIND SALINE-CONTROLLED TRIAL
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPHI-DACI
Brief Summary:
The goal of this clinical trial is to evaluate the efficacy of a posterior perineal block performed under neurostimulation at 1 month after local anesthetic infiltration in the treatment of chronic idiopathic ano-perineal pain
The main questions aims to answer are
1 The efficacy of a posterior perineal block performed under neurostimulation on pain 1 month after local anesthetic infiltration in the treatment of chronic idiopathic ano-perineal pain
2 The rate of maintenance at 3 months of a positive response to the first infiltration
3 The pain-free rate at 1 month after the first infiltration
4 Evolution of quality of life and pain impact between inclusion and one month after the first infiltration
5 Changes in anxiety and depressive disorders associated with pain between inclusion and one month after the first infiltration
6 The evolution of symptoms related to central sensitization both somatic and emotional between inclusion and one month after the first infiltration
Participants will
be managed with a posterior perineal block of lidocaine or saline solution under neurostimulation
complete a questionnaire on pain anxiety and depression at inclusion and one month after injection of the research product lidocaine or saline solution
Researchers will compare between the two treatment arms lidocaine versus saline solution to see the rate of patients with a reduction of at least 3 points on a visual analog pain scale between inclusion and 1 month after the first injection
The main questions aims to answer are
1 The efficacy of a posterior perineal block performed under neurostimulation on pain 1 month after local anesthetic infiltration in the treatment of chronic idiopathic ano-perineal pain
2 The rate of maintenance at 3 months of a positive response to the first infiltration
3 The pain-free rate at 1 month after the first infiltration
4 Evolution of quality of life and pain impact between inclusion and one month after the first infiltration
5 Changes in anxiety and depressive disorders associated with pain between inclusion and one month after the first infiltration
6 The evolution of symptoms related to central sensitization both somatic and emotional between inclusion and one month after the first infiltration
Participants will
be managed with a posterior perineal block of lidocaine or saline solution under neurostimulation
complete a questionnaire on pain anxiety and depression at inclusion and one month after injection of the research product lidocaine or saline solution
Researchers will compare between the two treatment arms lidocaine versus saline solution to see the rate of patients with a reduction of at least 3 points on a visual analog pain scale between inclusion and 1 month after the first injection
Detailed Description:
Chronic idiopathic ano-perineal pain CICA is defined as anoperineal pain involving the anal region that has been present for more than 3 months and for which no cause has been identified on clinical examination or further investigations MRI The mechanisms underlying this pain are multiple but involve the pudendal nerve in the majority of cases
Therapeutic management of CDAD is based on 3 treatment strategies of progressively increasing aggressiveness drug treatment infiltrations and decompressive surgery
Drug treatment is based on the empirical use of neuropathic pain medications with proven efficacy in other areas shingles diabetes etc Patients are generally considered to be non-responders to drug treatment after failure decrease in VAS scale lt 3 of at least one antidepressant and one antiepileptic whose dosages have been brought up to the maximum possible or in whom a side effect has prevented the dose from being increased to its authorized maximum
Therapeutic infiltrations most often involve the pudendal nerve ITNP Infiltration of the posterior branches of the sacrococcygeal roots is sometimes associated to create a posterior perineal block PPB There is no consensus or recommendation on which molecules to use
In most studies a combination of local anesthetics and corticosteroids was used However Labat et al published the only randomized controlled trial comparing lidocaine infiltration of the pudendal nerve with or without methylprednisolone Results were not significantly different 14 vs 11
According to the literature short-term pain relief up to 3 months was achieved in less than half of patients 11 to 39 and at 1 year pain relief was still present in only around 10 68 to 122 of patients The only recognized risk factor for failure appears to be the duration of pain greater than 1 year Other risk factors have been described in the literature but only in one study and not in the others such as gender male or female age over or under 70 duration of pain over or under 1 year and whether the pain is bilateral or not
Currently in our department patients are treated with lidocaine BPP under neurostimulation Given the poor results in terms of efficacy and the strong psychological component in chronic pain pathologies investigators propose in this study to compare our usual management against placebo Indeed no type of infiltration has ever been compared to a placebo
-Main objective evaluate the efficacy of BPP performed under neurostimulation on pain at 1 month after local anesthetic infiltration in the treatment of SCID
Primary endpoint
Comparison between the two treatment arms lidocaine versus saline solution of the rate of patients with a reduction of at least 3 points on a visual analog pain scale VAS between inclusion and 1 month after the first injection
-Secondary objectives
Compare between the two treatment arms
1 3-month maintenance rate of positive response to first infiltration
2 Pain-free rate at 1 month after first infiltration
3 Evolution of quality of life and pain impact between inclusion and one month after the first infiltration
4 Change in anxiety and depressive disorders associated with pain between inclusion and one month after the first infiltration
5 The evolution of symptoms related to central sensitization both somatic and emotional between inclusion and one month after the first infiltration
At the end of the interventional phase patients will be managed according to the department39s usual procedures Accepting patients will be included in a follow-up cohort for one year
Secondary endpoints
1 Maintenance of positive response at 3 months defined as a reduction of at least 3 VAS points compared with inclusion 3 months after infiltration
2 Percentage of patients with a VAS score equal to 0 at 1 month after the first infiltration
3 Delta of the score on question 9 of the modified Concise Pain Questionnaire CPQ French version of the Brief Pain Inventory concerning the impact of pain
4 Delta of scores A anxiety dimension and D depression dimension on the HAD scale
5 Delta of the score for part A of the French version of the CSI central sensitization score
Research procedures Placebo arm Infiltration by injections of 6mL saline per injection site left ischial-anal fossa right ischial-anal fossa coccyx
Treatment arm Infiltration by injections of 6mL lidocaine 10 mgmL per injection site left ischio-anal fossa right ischio-anal fossa coccyx
-Practical research procedure Pre-inclusion visit D0-min 1 week Eligible patients will be identified during the proctology consultation They will be given an information note about the study and will have at least 1 week to think about it before the next consultation
Inclusion visit and 1st infiltration D0
Verification of inclusionnon-inclusion criteria
Patient and physician sign consent form
Completion of scales and questionnaires EVA HAD QCD CSI
Randomization
Infiltration according to randomization arm
Collection of adverse events AEs and serious adverse events SAEs Visit 1 D01month
Collection of adverse events AEs and serious adverse events SAEs
Completion of scales and questionnaires EVA HAD QCD CSI In the event of a negative response decrease in VAS of less than 3 points patients will be managed according to the department39s routine
Telephone call patients with a positive response will be called two months later ie 3 months after infiltration for a telephone evaluation of VAS In the event of a VAS increase of more than 2 points a proctology consultation will be proposed
Adverse events AEs and serious adverse events SAEs will also be recorded during the telephone call
End-of-study visit
In the event of a negative response decrease in VAS of less than 3 points Visit 1 1 month 3 days will correspond to the end-of-study visit
If the patient has a positive response the end-of-study visit will correspond to the telephone visit 3 months - 1 week after infiltration
Number of patients This is a pilot study in which investigators plan to include 30 patients per arm for a total of 60 patients
Statistical method The rate of successful patients at M1 between the two randomization arms will be analyzed using logistic regression with treatment success or failure as the explanatory variable and randomization arm and duration of pain stratification factor as the explanatory variables
Provisional timetable Duration of inclusion period 60 months Duration of participation of each subject 3 months Total study duration 63 months
Therapeutic management of CDAD is based on 3 treatment strategies of progressively increasing aggressiveness drug treatment infiltrations and decompressive surgery
Drug treatment is based on the empirical use of neuropathic pain medications with proven efficacy in other areas shingles diabetes etc Patients are generally considered to be non-responders to drug treatment after failure decrease in VAS scale lt 3 of at least one antidepressant and one antiepileptic whose dosages have been brought up to the maximum possible or in whom a side effect has prevented the dose from being increased to its authorized maximum
Therapeutic infiltrations most often involve the pudendal nerve ITNP Infiltration of the posterior branches of the sacrococcygeal roots is sometimes associated to create a posterior perineal block PPB There is no consensus or recommendation on which molecules to use
In most studies a combination of local anesthetics and corticosteroids was used However Labat et al published the only randomized controlled trial comparing lidocaine infiltration of the pudendal nerve with or without methylprednisolone Results were not significantly different 14 vs 11
According to the literature short-term pain relief up to 3 months was achieved in less than half of patients 11 to 39 and at 1 year pain relief was still present in only around 10 68 to 122 of patients The only recognized risk factor for failure appears to be the duration of pain greater than 1 year Other risk factors have been described in the literature but only in one study and not in the others such as gender male or female age over or under 70 duration of pain over or under 1 year and whether the pain is bilateral or not
Currently in our department patients are treated with lidocaine BPP under neurostimulation Given the poor results in terms of efficacy and the strong psychological component in chronic pain pathologies investigators propose in this study to compare our usual management against placebo Indeed no type of infiltration has ever been compared to a placebo
-Main objective evaluate the efficacy of BPP performed under neurostimulation on pain at 1 month after local anesthetic infiltration in the treatment of SCID
Primary endpoint
Comparison between the two treatment arms lidocaine versus saline solution of the rate of patients with a reduction of at least 3 points on a visual analog pain scale VAS between inclusion and 1 month after the first injection
-Secondary objectives
Compare between the two treatment arms
1 3-month maintenance rate of positive response to first infiltration
2 Pain-free rate at 1 month after first infiltration
3 Evolution of quality of life and pain impact between inclusion and one month after the first infiltration
4 Change in anxiety and depressive disorders associated with pain between inclusion and one month after the first infiltration
5 The evolution of symptoms related to central sensitization both somatic and emotional between inclusion and one month after the first infiltration
At the end of the interventional phase patients will be managed according to the department39s usual procedures Accepting patients will be included in a follow-up cohort for one year
Secondary endpoints
1 Maintenance of positive response at 3 months defined as a reduction of at least 3 VAS points compared with inclusion 3 months after infiltration
2 Percentage of patients with a VAS score equal to 0 at 1 month after the first infiltration
3 Delta of the score on question 9 of the modified Concise Pain Questionnaire CPQ French version of the Brief Pain Inventory concerning the impact of pain
4 Delta of scores A anxiety dimension and D depression dimension on the HAD scale
5 Delta of the score for part A of the French version of the CSI central sensitization score
Research procedures Placebo arm Infiltration by injections of 6mL saline per injection site left ischial-anal fossa right ischial-anal fossa coccyx
Treatment arm Infiltration by injections of 6mL lidocaine 10 mgmL per injection site left ischio-anal fossa right ischio-anal fossa coccyx
-Practical research procedure Pre-inclusion visit D0-min 1 week Eligible patients will be identified during the proctology consultation They will be given an information note about the study and will have at least 1 week to think about it before the next consultation
Inclusion visit and 1st infiltration D0
Verification of inclusionnon-inclusion criteria
Patient and physician sign consent form
Completion of scales and questionnaires EVA HAD QCD CSI
Randomization
Infiltration according to randomization arm
Collection of adverse events AEs and serious adverse events SAEs Visit 1 D01month
Collection of adverse events AEs and serious adverse events SAEs
Completion of scales and questionnaires EVA HAD QCD CSI In the event of a negative response decrease in VAS of less than 3 points patients will be managed according to the department39s routine
Telephone call patients with a positive response will be called two months later ie 3 months after infiltration for a telephone evaluation of VAS In the event of a VAS increase of more than 2 points a proctology consultation will be proposed
Adverse events AEs and serious adverse events SAEs will also be recorded during the telephone call
End-of-study visit
In the event of a negative response decrease in VAS of less than 3 points Visit 1 1 month 3 days will correspond to the end-of-study visit
If the patient has a positive response the end-of-study visit will correspond to the telephone visit 3 months - 1 week after infiltration
Number of patients This is a pilot study in which investigators plan to include 30 patients per arm for a total of 60 patients
Statistical method The rate of successful patients at M1 between the two randomization arms will be analyzed using logistic regression with treatment success or failure as the explanatory variable and randomization arm and duration of pain stratification factor as the explanatory variables
Provisional timetable Duration of inclusion period 60 months Duration of participation of each subject 3 months Total study duration 63 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None