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

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University Hospital Center (CHU)

Status and phase

Completed
Phase 3

Conditions

Ambulatory Plastic Surgery
Esthetic Prosthetic Breast Expansion

Treatments

Drug: Ropivacaine after dilution with sodium chloride 0.9%

Study type

Interventional

Funder types

Other

Identifiers

NCT02682186
95832
2015-002368-17 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

74 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

74 participants in 2 patient groups

Control group (1)
No Intervention group
Description:
The PECS Blocks are not (1) performed.
PECS group (2)
Experimental group
Description:
The PECS Blocks are performed (2): A single injection of Ropivacaine after dilution with sodium chloride 0.9% per fascial plane and per side.
Treatment:
Drug: Ropivacaine after dilution with sodium chloride 0.9%

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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