Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06534775
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
PABLOS 20 - Chronic Pain After Sternotomy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
PABLOS 20 - Chronic Pain After Sternotomy Prospective Non-interventional Study
Status:
RECRUITING
Status Verified Date:
2024-08
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:
PABLOS2
Brief Summary:
The PABLOS study NCT05345639 recently realised at the University Hospital of Angers looked at the place of loco-regional anesthesia LRA in the optimization of analgesia and the early post-operative recovery of patients operated from cardiac surgery by sternotomy
All randomized patients n253 were followed for 30 days as part of PABLOS monitoring with the aim of optimizing acute care
However sternotomy surgery causes chronic pain with neuropathic components Indeed numerous recent studies suggest that cardiac surgery by median sternotomy is associated with the development of chronic sternal pain with an incidence of 11 to 56 one year after surgery Most patients with chronic post-sternotomies pain report mild pain 1 to 3 on the Numerical Scale however up to 18 report moderate to severe pain 4 to 10 on the EN
It therefore seems important to the investigator to evaluate the prevalence of chronic post-sternotomies pain within our PABLOS cohort and to know whether performing a post-operative LRA limits their occurrence
All randomized patients n253 were followed for 30 days as part of PABLOS monitoring with the aim of optimizing acute care
However sternotomy surgery causes chronic pain with neuropathic components Indeed numerous recent studies suggest that cardiac surgery by median sternotomy is associated with the development of chronic sternal pain with an incidence of 11 to 56 one year after surgery Most patients with chronic post-sternotomies pain report mild pain 1 to 3 on the Numerical Scale however up to 18 report moderate to severe pain 4 to 10 on the EN
It therefore seems important to the investigator to evaluate the prevalence of chronic post-sternotomies pain within our PABLOS cohort and to know whether performing a post-operative LRA limits their occurrence
Detailed Description:
PABLOS 20 is a non-interventional cohort study with prospective data collection by telephone questionnary with three groups from a single-center superiority interventional study Patients remained blinded for the duration of the study
The patients in the cohort come from the precedent PABLOS study NCT05345639 They receive oral and written information and confirm orally their non-opposition to participating in the PABLOS 20 study
The specific procedures of the PABLOS 20 study are the collection using a telephone questionnary of the score of the numerical scale from 0 to 10 of pain at rest and with effort of the DN4 proportion of chronic pain with a neuropathic component of the EQ-5D-5L scale quality of life and of consumption of painkillers
The patients in the cohort come from the precedent PABLOS study NCT05345639 They receive oral and written information and confirm orally their non-opposition to participating in the PABLOS 20 study
The specific procedures of the PABLOS 20 study are the collection using a telephone questionnary of the score of the numerical scale from 0 to 10 of pain at rest and with effort of the DN4 proportion of chronic pain with a neuropathic component of the EQ-5D-5L scale quality of life and of consumption of painkillers
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