Serratus Plane Block for the Prevention of Chronic Pain After Breast Cancer 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

UNKNOWN

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-03-31

Brief Summary

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This study compare the "Serratus block plane" (SPB) and the local infiltration of the tissue in the prevention of acute and chronic pain after breast cancer surgery.

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Detailed Description

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Chronic pain after breast surgery may be severe, often requiring the use of morphine. The incidence of chronic pain varies from 27 to 50% depending on definitions.

The infiltration of tissues by a local anesthetic is a simple, fast and low risk technique but of limited effectiveness.

Serratus the flat block, performed under ultrasound guidance, is minimally invasive and easy to perform. It allows anesthesia and analgesia to an extended part of the anterolateral chest wall and the axilla. This regional anesthesia technique provides good analgesia during and after breast surgery, but remains to be evaluated; beyond perioperative analgesia, the benefit-risk, post operative rehabilitation, and the impact on ambulatory and on chronic pain are fundamental objectives.

Conditions

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Breast/Surgery Postoperative Complication Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SPB

Serratus Plane Bloc with Ropivacaine 2mg/ml (0,3ml/kg) and tissue infiltration with placebo made once, by the anesthetist in the operating theater before surgical incision

Group Type EXPERIMENTAL

serratus plane bloc : Ropivacaine 2mg/ml (0,3ml/kg)

Intervention Type PROCEDURE

tissue infiltration : placebo

Intervention Type PROCEDURE

tissue infiltration

tissue infiltration with Ropivacaine 2mg/ml (0,3ml/kg) and Serratus Plane Bloc with placebo made once, by the anesthetist in the operating theater before surgical incision

Group Type ACTIVE_COMPARATOR

tissue infiltration : Ropivacaine 2mg/ml (0,3ml/kg)

Intervention Type PROCEDURE

serratus plane bloc : placebo

Intervention Type PROCEDURE

Interventions

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serratus plane bloc : Ropivacaine 2mg/ml (0,3ml/kg)

Intervention Type PROCEDURE

tissue infiltration : Ropivacaine 2mg/ml (0,3ml/kg)

Intervention Type PROCEDURE

serratus plane bloc : placebo

Intervention Type PROCEDURE

tissue infiltration : placebo

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Women scheduled for elective breast neoplasm surgery
* Of ASA classification 1, 2 or 3
* Patients who provide written informed consent

Exclusion Criteria

* Minor patients
* Patients refusing to sign the consent
* Patients included in another protocol within 3 months
* Pregnant or lactating patients
* Patients with history of allergy to local anesthetics (Ropivacaine)
* Patients with contraindication to regional anesthesia (coagulopathy, local infection ...)
* Patients with history of prior breast surgery (excluding diagnostic biopsy)
* Patients with history of chronic pain
* Patients with a history of psychiatric disorder

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No