Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-03-04 @ 3:20 PM
Study NCT ID:
NCT03832920
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2019-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analgesia Nociception Index (ANI) After Unilateral Radical Mastectomy as an Evaluation of Paravertebral Block Failure
Sponsor:
Institut de Cancérologie de Lorraine
Organization:
Study Overview
Official Title:
Analgesia Nociception Index (ANI) After Unilateral Radical Mastectomy as an Evaluation of Paravertebral Block Failure
Status:
COMPLETED
Status Verified Date:
2023-06
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:
ANIBPV
Brief Summary:
Paravertebral Block (PVB) combined with general anesthesia (GA) is a conventional pain treatment for breast surgery but sometimes failures can occurs. The efficacy of this block has to be evaluated. Also, for the intra-operative analgesic evaluation of this block, it is necessary to measure intra-operative analgesia index. A monitor of nociception for patients under GA, the PhysiodolorisTM device, offers an index for measuring nociceptive inputs during surgery in anesthetized patients : the ANI index (based on the single R-R interval analysis). The purpose of this observational and prospective study is to assess the variations of this ANI index during breast surgery with or without axillary node dissection with a PVB. This will allow us to quantify the analgesic effect of a PVB during GA for unilateral radical breast surgery with or without axillary node dissection.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: