Pectoral Nerve Block for Analgesia After Breast Augmentation (PECS B&BS)

Effects of the Pectoral Blocks in the Prosthetic Breast Expansion Surgery : Prospective, Randomized, Double Blind Study.

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.

Study Overview

• Status: Completed
• Conditions: Ambulatory Plastic Surgery; Esthetic Prosthetic Breast Expansion
• Intervention / Treatment: Drug: Ropivacaine after dilution with sodium chloride 0.9%

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 Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • UH Montpellier
  • Montpellier, France, 34295
    • UH Montpellier - Hôpital Gui de Chauliac
  • Nîmes, France, 30029
    • CHU Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group (1); The PECS Blocks are not (1) performed.
Experimental: PECS group (2); The PECS Blocks are performed (2): A single injection of Ropivacaine after dilution with sodium chloride 0.9% per fascial plane and per side.	Drug: Ropivacaine after dilution with sodium chloride 0.9%; After the anesthesic induction, the interventional team composed by at least a senior anaesthesiologist and a nurse anesthestic, will survey the patient and perform the Pecs blocks, whereas the anesthetic team is outside the room. Realization of Pecs blocks 1 and 2 : the patient is in supine position with placing the upper limb in abduction position, a 100 mm needle is inserted under ultrasound using a linear US probe of high frequency after sheathing. In the other group, sterilization, sheating and US are performed but the needle is not inserted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximal value of pain intensity according to the numerical scale within the six first hours	up to First six postoperative hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Chair: Gérald GC CHANQUES, MD, PhD, Montpellier University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): October 3, 2019
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: February 4, 2016
• First Submitted That Met QC Criteria: February 12, 2016
• First Posted (Estimate): February 15, 2016

Study Record Updates

• Last Update Posted (Actual): July 10, 2020
• Last Update Submitted That Met QC Criteria: July 9, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Pain; Postoperative analgesia; Pectoral nerve block; Prosthetic breast surgery; Locoregional anesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 95832; 2015-002368-17 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided