Clinical trial NCT02682186: Pectoral Nerve Block for Analgesia After Breast Augmentation
Official title: Effects of the Pectoral Blocks in the Prosthetic Breast Expansion Surgery : Prospective, Randomized, Double Blind Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ambulatory Plastic Surgery
Esthetic Prosthetic Breast Expansion
Keywords: Prosthetic breast surgery
Locoregional anesthesia
Pectoral nerve block
Pain
Postoperative analgesia
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-02-15
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximal value of pain intensity according to the numerical scale within the six first hours
timeFrame: up to First six postoperative hours
Secondary outcomes:
measure: Maximal value of the pain at day 1 and until day 5
timeFrame: Five days
measure: Morphinics side effects such as nausea / vomiting, constipation, pruritus; analgesic consumption, surgical complication, satisfaction questionaire
timeFrame: Five days
Other outcomes:
Locations:
city: Montpellier
country: France
facility: UH Montpellier - Hôpital Gui de Chauliac
city: Montpellier
country: France
facility: UH Montpellier
city: Nîmes
country: France
facility: CHU Nîmes
Study officials:
affiliation: Montpellier University Hospital
name: Gérald GC CHANQUES, MD, PhD
role: STUDY_CHAIR
References: