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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02963857
• Other study ID #: Evaluation of a breast biblock
• Status: Completed
• Phase: N/A
• First received: November 10, 2016
• Last updated: November 16, 2016
• Start date: March 2016
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: Maison de Santé Prostestante de Bordeaux Bagatelle
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Pain
• Anesthesia
• Mastectomy, Segmental

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Maison de Santé Prostestante de Bordeaux Bagatelle

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary goal of the study is to evaluate the postoperative morphine consumption until 72 hours after the surgery.		3 days	No
Secondary	Pain levels on a numeric pain rating scale were recorded at rest and with arm mobilization during the first 72 hours.		3 days	No
Secondary	level of comfort during the first 72 hours was recorded (the 4 levels-scale used was: excellent, good, medium and bad).		3 days	No