Pectoral Nerve Block for Analgesia After Breast Augmentation

NCT ID: NCT02682186

Last Updated: 2020-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-01
• Study Completion Date: 2020-07-01

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.

Conditions

Ambulatory Plastic Surgery; Esthetic Prosthetic Breast Expansion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control group (1)

The PECS Blocks are not (1) performed.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Ropivacaine after dilution with sodium chloride 0.9%

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gérald GC CHANQUES, MD, PhD

Role: STUDY_CHAIR

Montpellier University Hospital

Locations

UH Montpellier - Hôpital Gui de Chauliac

Montpellier, , France

UH Montpellier

Montpellier, , France

CHU Nîmes

Nîmes, , France

Countries

France

Other Identifiers

2015-002368-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

95832

Identifier Type: -

Identifier Source: org_study_id