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

November 16, 2016 updated by: Dr Claude-Charles Balick-Weber, Maison de Santé Prostestante de Bordeaux Bagatelle
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.

Study Overview

Status

Completed

Conditions

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 the investigators hospital in every day's practice, an association of the serratus block and the PIF block is made, 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 analgesia of the lateral part of the breast.

This technique was previously described. The authors evoked the possibility of the association of serratus and PIF blocks and described this technique with a patient, but to the investigators knowledge no evaluation of the efficacy of this procedure was made.

The objective of the 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 a current practice in this type of surgery.

Study Type

Observational

Enrollment (Actual)

9

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary goal of the study is to evaluate the postoperative morphine consumption until 72 hours after the surgery.
Time Frame: 3 days
3 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain levels on a numeric pain rating scale were recorded at rest and with arm mobilization during the first 72 hours.
Time Frame: 3 days
3 days
level of comfort during the first 72 hours was recorded (the 4 levels-scale used was: excellent, good, medium and bad).
Time Frame: 3 days
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maison de Santé Prostestante de Bordeaux Bagatelle

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

November 10, 2016

First Submitted That Met QC Criteria

November 10, 2016

First Posted (Estimate)

November 15, 2016

Study Record Updates

Last Update Posted (Estimate)

November 17, 2016

Last Update Submitted That Met QC Criteria

November 16, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Evaluation of a breast biblock

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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