Evaluation of a Breast Double Block Analgesia for the Mastectomy With Radical Axillary Lymphadenectomy Surgery

Mastectomy Clinical Trial

Official title:

Evaluation of a Breast Double Block Analgesia for the Mastectomy With Radical Axillary Lymphadenectomy Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03177733
• Other study ID #: Evaluation of breast biblock 2
• Status: Completed
• Start date: June 20, 2017
• Est. completion date: July 1, 2018

Study information

• Verified date: November 2018
• Source: Maison de Santé Prostestante de Bordeaux Bagatelle
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 1, 2018
• Est. primary completion date: June 1, 2018
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• total mastectomy surgery with a complete axillary lymph nodes removal

Exclusion Criteria:

• age under 18

• contraindication to the surgery

• refusal of the protocol by the patient

Related Conditions & MeSH terms

• Mastectomy

Intervention

Procedure:
• Evaluation of a breast double block
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. The objective is to analyze this technique through a collection form that evaluates the satisfaction and post-operative morphine consumption of women receiving this association 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.

Locations

Country	Name	City	State
France	Maison de Santé Protestante de Bordeaux-Bagatelle	Talence	Aquitaine

Sponsors (1)

Lead Sponsor	Collaborator
Maison de Santé Prostestante de Bordeaux Bagatelle

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative morphine consumption until 72 hours after the surgery.	The primary goal of the study is to evaluate the postoperative morphine consumption until 72 hours after the surgery.	3 days
Secondary	Pain levels during the first 72 hours.	Pain levels on a numeric pain rating scale were recorded at rest and with arm mobilization during the first 72 hours.	3 days
Secondary	Level of comfort during the first 72 hours	level of comfort during the first 72 hours was recorded (the 4 levels-scale used was: excellent, good, medium and bad).	3 days