Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05876390
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-11-09
First Post:
2023-03-24
Brief Title:
Impact of Regional Anesthesia on Chronic Post-operative Pain
Sponsor:
Niguarda Hospital
Organization:
Niguarda Hospital
Study Overview
Official Title:
Impact of Loco-regional Anesthesia Techniques on Chronic Post-surgery in Breast Oncological Surgery a Prospective Multicenter Observational Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-11
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:
IRACPoP
Brief Summary:
Approximately 55000 cases of breast cancer are diagnosed in Italy every year and the first-line therapy for carcinoma in situ stage I II and IIIA is surgical removal of the tumour The incidence of chronic pain after breast cancer surgery is confirmed around 30 This study aims to evaluate the impact of loco-regional anesthesia techniques in the context of multimodal analgesia in the prevention of chronic pain post-oncological breast surgery
Detailed Description:
Approximately 55000 cases of breast cancer are diagnosed in Italy every year and the first-line therapy for carcinoma in situ stage I II and IIIA is surgical removal of the tumour The incidence of chronic pain after breast cancer surgery is confirmed around 30Persistent postsurgical pain defined in the ICD-11 as pain that develops or increases in intensity after a surgical procedure or tissue damage and persists beyond the healing process for at least 3 months after the initial event and is considered a complication of surgery
Several pharmacological and non-pharmacological interventions have been proposed for the prevention of the development of this complication of surgical interventions including the intraoperative use of local anesthesia techniques in the context of multimodal analgesia
The purpose of this multicenter prospective observational study is to evaluate through the propensity score methodology how much the use of loco-regional anesthesia techniques can improve the outcome in terms of the development of chronic post-surgical pain of patients undergoing to oncological breast surgery
Several pharmacological and non-pharmacological interventions have been proposed for the prevention of the development of this complication of surgical interventions including the intraoperative use of local anesthesia techniques in the context of multimodal analgesia
The purpose of this multicenter prospective observational study is to evaluate through the propensity score methodology how much the use of loco-regional anesthesia techniques can improve the outcome in terms of the development of chronic post-surgical pain of patients undergoing to oncological breast surgery
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