Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-31 @ 10:28 AM
Study NCT ID:
NCT03177733
Status:
COMPLETED
Last Update Posted:
2018-11-28
First Post:
2017-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Breast Double Block Analgesia for the Mastectomy With Radical Axillary Lymphadenectomy Surgery
Sponsor:
Maison de Santé Prostestante de Bordeaux Bagatelle
Organization:
Study Overview
Official Title:
Evaluation of a Breast Double Block Analgesia for the Mastectomy With Radical Axillary Lymphadenectomy Surgery
Status:
COMPLETED
Status Verified Date:
2018-11
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:
None
Brief Summary:
This study evaluates the efficacy of the the pecto-intercostal fascial plane block (PIF block) for the anesthesia of the intercostal nerves anterior branches and assesses the association of the serratus block with a PIF block for the breast surgery.
To obtain a correct prospective clinical trial completion we have to begin a new series of inclusion.
To obtain a correct prospective clinical trial completion we have to begin a new series of inclusion.
Detailed Description:
Breast surgery is one of the most painful post-operative surgery. This surgery is well known to induce postoperative chronic pain. The paravertebral block, because of its efficacy and less invasive nature than epidural analgesia, is quickly becoming the reference technique for pain management of major breast surgery.
Peripheral regional anesthesia for the breast surgery appeared in the past few years. Among these techniques are the PEC block, Serratus block and more recently the pecto-intercostal fascial plane block (PIF block).
Currently in our hospital in every day's practice, we made an association of the serratus block and the PIF block, which allows for a complete block of both the laterals branches of intercostal nerves (with the serratus block) and of anterior branches of intercostal nerves (with the PIF block). Therefore, this association of blocks may lead to a complete analgesia of the breast, while the serratus block alone only allows for an analgesia of the lateral part of the breast.
This technique was described by Fajardo et al. They evoked the possibility of the association serratus and PIF blocks and described this technique with a patient, but to our knowledge no evaluation of the efficacy of this procedure was made.
The objective of your study is to analyze this technique through a collection form that evaluates the satisfaction and post-operative morphine consumption of women receiving this association of blocks before a general anesthesia for a unilateral mastectomy with homolateral total lymphadenectomy.
This is a purely observational study that assesses our current practice in this type of surgery.
we already included a patient series but the clinical trial registration was made to late to do it correctly. To obtain a correct prospective clinicaltrials registration completion we have to begin a new series of inclusion.
Peripheral regional anesthesia for the breast surgery appeared in the past few years. Among these techniques are the PEC block, Serratus block and more recently the pecto-intercostal fascial plane block (PIF block).
Currently in our hospital in every day's practice, we made an association of the serratus block and the PIF block, which allows for a complete block of both the laterals branches of intercostal nerves (with the serratus block) and of anterior branches of intercostal nerves (with the PIF block). Therefore, this association of blocks may lead to a complete analgesia of the breast, while the serratus block alone only allows for an analgesia of the lateral part of the breast.
This technique was described by Fajardo et al. They evoked the possibility of the association serratus and PIF blocks and described this technique with a patient, but to our knowledge no evaluation of the efficacy of this procedure was made.
The objective of your study is to analyze this technique through a collection form that evaluates the satisfaction and post-operative morphine consumption of women receiving this association of blocks before a general anesthesia for a unilateral mastectomy with homolateral total lymphadenectomy.
This is a purely observational study that assesses our current practice in this type of surgery.
we already included a patient series but the clinical trial registration was made to late to do it correctly. To obtain a correct prospective clinicaltrials registration completion we have to begin a new series of inclusion.
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?: