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

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.

Study Overview

• Status: Completed
• Conditions: Mastectomy
• Intervention / Treatment: Procedure: Evaluation of a breast double block

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.

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• France
  • Aquitaine
    • Talence, Aquitaine, France, 33401
      • Maison de Santé Protestante de Bordeaux-Bagatelle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

All patients included in the study have had a total mastectomy surgery with a complete axillary lymph nodes removal.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Maison de Santé Prostestante de Bordeaux Bagatelle
• Investigators: Principal Investigator: Claude-charles Balick-weber, Maison de Santé Protestante de Bordeaux-Bagatelle

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 20, 2017
• Primary Completion (ACTUAL): June 1, 2018
• Study Completion (ACTUAL): July 1, 2018

Study Registration Dates

• First Submitted: June 2, 2017
• First Submitted That Met QC Criteria: June 2, 2017
• First Posted (ACTUAL): June 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 28, 2018
• Last Update Submitted That Met QC Criteria: November 27, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: acute pain; regional anesthesia; breast surgery
• Other Study ID Numbers: Evaluation of breast biblock 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No