PECS I Block for Breast Subpectoral Implant Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-16

Study Completion Date

2020-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Control group

PECS block performed with Saline solution instead of local anesthetic

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

20 mL saline 0.9%

PECS group

PECS block performed with Ropivacaine 3.75mg/mL

Group Type EXPERIMENTAL

Ropivacaine (PECS bloc)

Intervention Type DRUG

Ropivacaine 3.75mg/mL

Injection of a local anesthetic between pectoral major and pectoral minor muscles

Interventions

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Ropivacaine (PECS bloc)

Ropivacaine 3.75mg/mL

Injection of a local anesthetic between pectoral major and pectoral minor muscles

Intervention Type DRUG

Placebo

20 mL saline 0.9%

Intervention Type DRUG

Other Intervention Names

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ropivacaine saline

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No