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PECS I Block for Breast Subpectoral Implant Surgery

U

University Hospital, Lille

Status

Completed

Conditions

Pain, Postoperative

Treatments

Drug: Ropivacaine (PECS bloc)
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02849236
2016-000157-12 (EudraCT Number)
2015_17

Details and patient eligibility

About

Breast augmentation surgery can cause important postoperative pain, especially when bilateral subpectoral implants are used. The investigators hypothesized that a technique of regional analgesia, the pectoral nerve block type I (or "PECS I block") would reduce pain within the first twenty-four hours and, in turn, morphine consumption and associated side effects. This is a randomized, controlled, double-blind study which compares intra and postoperative analgesia with or without PECS I block in breast surgery.

Enrollment

56 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Every female who will benefit of a bilateral subpectoral breast augmentation
  • Age more than 18 years
  • Social insured

Exclusion criteria

  • refusal of the patient
  • Age less than 18 years
  • Inability to consent
  • History of thoracic surgery or breast implants
  • Pregnancy
  • Inability to use a patient controlled analgesia
  • Contraindication of the use of opioids or local anesthetics
  • Pathology of hemostasis, infection
  • Can not use a PCA
  • Patients under long-term opioids (WHO pain ladder 2 and 3)
  • Patient presenting neuropathic pain during the preoperative period (score greater than or equal to 4 to the DN4 questionnaire, or taking anti-epileptic or antidepressant treatments for neuropathic pain)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

56 participants in 2 patient groups, including a placebo group

Control group
Placebo Comparator group
Description:
PECS block performed with Saline solution instead of local anesthetic
Treatment:
Drug: Placebo
PECS group
Experimental group
Description:
PECS block performed with Ropivacaine 3.75mg/mL
Treatment:
Drug: Ropivacaine (PECS bloc)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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