Pectoral Nerve Block for Analgesia After Breast Augmentation

Phase 3

Completed

• Conditions: Ambulatory Plastic Surgery; Esthetic Prosthetic Breast Expansion
• Interventions: Drug: Ropivacaine after dilution with sodium chloride 0.9%

• Registration Number: NCT02682186
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

Breast augmentation is among the most popular surgical procedures performed in the world with approximately 1,773,584 performed in 2013. This surgical intervention generates important pains during postsurgical recovery. A multimodal analgesia, based on the recommendations is proposed to the patients .The pectoral nerve block is an innovative technique of locoregional anesthesia that has already been successfully used in breast surgery. Its realization is fast, simple, and it would be superior compared with a paravertebral block within the framework of mastectomy. The interest of this technique has never been assessed in esthetic breast surgery. The aim of this study is to evaluate the analgesic efficacy of the association of " Pecs blocks 1 and 2 " on pain intensity after breast augmentation surgery.

Detailed Description

The investigators hypothesized that the "Pecs blocks 1 and 2" will provide a decrease of the maximal pain of the first 6 post-operative hours after prosthetic breast expansion. The pain will be assessed according to a numerical scale. This prospective, randomized, double blind study will include 92 patients successively during two years, randomized into two arms : Pecs group and Control group, which will respectively have the block, and no block. The rest of the anesthesic and surgical care will be identical.

An intervention team (which will be different from the anesthesic team), will be alone with the patient for 15 minutes, and will realize or not the Pecs blocks according to the previous randomisation so that all caregivers taking in charge the patients as well as research observers will be blinded.

Study Timeline

• Study Start: 2016-02-01
• Study First Submitted: 2016-02-04
• Study First Submitted QC: 2016-02-12
• Study First Posted: 2016-02-15
• Primary Completion: 2019-10-03
• Status Verified: 2020-07
• Study Completion: 2020-07-01
• Last Update Submitted: 2020-07-09
• Last Update Posted: 2020-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 74

Inclusion Criteria

• Affiliated to a national insurance scheme
• Having signed the informed consent for this study
• Score of American Society of Anesthesiology ( ASA) 1-3
• Be hospitalized in the ambulatory care unit (UCA) or plastic surgery service for a scheduled esthetic prosthetic breast expansion surgery.

Exclusion Criteria

• Protected minor or major patients or in the incapacity to give his consent according to the article L1121-8 of the Code of the Health Public.
• Pregnant or breast-feeding women according to French law.
• Vulnerable people.
• Patients participating in another research
• Allergy with local anesthetics.
• Severe coagulopathy.
• Chronic painful Patients (long-term treatment by analgesics)
• Contraindication to use analgesics of the protocol.
• Change of breast prostheses

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PECS group (2)	Ropivacaine after dilution with sodium chloride 0.9%	The PECS Blocks are performed (2): A single injection of Ropivacaine after dilution with sodium chloride 0.9% per fascial plane and per side.

Primary Outcome Measures

Name	Time	Method
Maximal value of pain intensity according to the numerical scale within the six first hours	up to First six postoperative hours

Secondary Outcome Measures

Name	Time	Method
Maximal value of the pain at day 1 and until day 5	Five days	Value of pain according to a Numeric scale , recorded at day 1 in the hospital, and until day five by phone interview.
Morphinics side effects such as nausea / vomiting, constipation, pruritus; analgesic consumption, surgical complication, satisfaction questionaire	Five days	Any of side effect

Trial Locations

Locations (3)

UH Montpellier - Hôpital Gui de Chauliac; 🇫🇷 Montpellier, France

UH Montpellier; 🇫🇷 Montpellier, France

CHU Nîmes; 🇫🇷 Nîmes, France