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OpenTrials
Completed

NCT Number: NCT02963857

Evaluation of a Breast Biblock 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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

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 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.

Who can participate

Healthy volunteers accepted: No

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

Primary outcomes

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

    Time frame: 3 days

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Maison de Santé Prostestante de Bordeaux Bagatelle

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Nov 15, 2016
Registry last updated
Nov 17, 2016

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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