Pectoral Nerve Block for Analgesia After Breast Augmentation

NCT02682186 | Completed Phase 3

• 2 other identifiers: 958322015-002368-17
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 3

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.

Conditions

Ambulatory Plastic Surgery; Esthetic Prosthetic Breast Expansion

Keywords

Prosthetic breast surgery; Locoregional anesthesia; Pectoral nerve block; Pain; Postoperative analgesia

Outcome Measures

Primary Outcomes (1)

• Maximal value of pain intensity according to the numerical scale within the six first hours

  up to First six postoperative hours

Secondary Outcomes (2)

• Maximal value of the pain at day 1 and until day 5

  Five days

• Morphinics side effects such as nausea / vomiting, constipation, pruritus; analgesic consumption, surgical complication, satisfaction questionaire

  Five days

Study Arms (2)

Control group (1)

NO INTERVENTION

The PECS Blocks are not (1) performed.

PECS group (2)

EXPERIMENTAL

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%

Interventions

Ropivacaine after dilution with sodium chloride 0.9% DRUG

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.

PECS group (2)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (3)

CHU Nîmes

Nîmes, Nîmes, 30029, France

Location

UH Montpellier - Hôpital Gui de Chauliac

Montpellier, 34295, France

Location

UH Montpellier

Montpellier, 34295, France

Location

Related Publications (1)

• Aarab Y, Ramin S, Odonnat T, Garnier O, Boissin A, Molinari N, Marin G, Perrigault PF, Cuvillon P, Chanques G. Pectoral Nerve Blocks for Breast Augmentation Surgery: A Randomized, Double-blind, Dual-centered Controlled Trial. Anesthesiology. 2021 Sep 1;135(3):442-453. doi: 10.1097/ALN.0000000000003855.

  PMID: 34195767 RESULT

MeSH Terms

Conditions

Pain

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Gérald GC CHANQUES, MD, PhD

  Montpellier University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: February 15, 2016
• Study Start: February 1, 2016
• Primary Completion: October 3, 2019
• Study Completion: July 1, 2020
• Last Updated: June 12, 2026

Record last verified: 2020-07

Locations

FR (3)