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OpenTrials
Completed

NCT Number: NCT03177733

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Maison de Santé Protestante de Bordeaux-Bagatelle

Talence, Aquitaine, 33401, France

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. postoperative morphine consumption until 72 hours after the surgery.

    Time frame: 3 days

    The primary goal of the study is to evaluate the postoperative morphine consumption until 72 hours after the surgery.

Secondary outcomes

  1. Pain levels during the first 72 hours.

    Time frame: 3 days

    Pain levels on a numeric pain rating scale were recorded at rest and with arm mobilization during the first 72 hours.

  2. Level of comfort during the first 72 hours

    Time frame: 3 days

    level of comfort during the first 72 hours was recorded (the 4 levels-scale used was: excellent, good, medium and bad).

Sponsors and collaborators

Lead sponsor

Maison de Santé Prostestante de Bordeaux Bagatelle

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 6, 2017
Registry last updated
Nov 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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