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

NCT03177733 | Completed

• 1 other identifier: Evaluation of breast biblock 2
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Mastectomy

Keywords

breast surgery; acute pain; regional anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pain levels during the first 72 hours.

  3 days

• Level of comfort during the first 72 hours

  3 days

Interventions

Evaluation of a breast double block PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• total mastectomy surgery with a complete axillary lymph nodes removal

You may not qualify if:

• age under 18
• contraindication to the surgery
• refusal of the protocol by the patient

Sponsors & Collaborators

• Maison de Santé Prostestante de Bordeaux Bagatelle: lead

Study Sites (1)

Maison de Santé Protestante de Bordeaux-Bagatelle

Talence, Aquitaine, 33401, France

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Claude-charles Balick-weber

  Maison de Santé Protestante de Bordeaux-Bagatelle

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: June 6, 2017
• Study Start: June 20, 2017
• Primary Completion: June 1, 2018
• Study Completion: July 1, 2018
• Last Updated: November 28, 2018

Record last verified: 2018-11

Locations

FR (1)