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

Study Overview
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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.

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.

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

Conditions
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Breast/Surgery, Postoperative Complication, Chronic Pain

Intervention / Treatment
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* Procedure: serratus plane bloc : Ropivacaine 2mg/ml (0,3ml/kg)
* Procedure: tissue infiltration : Ropivacaine 2mg/ml (0,3ml/kg)
* Procedure: serratus plane bloc : placebo
* Procedure: tissue infiltration : placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPB<br>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 | Procedure: serratus plane bloc : Ropivacaine 2mg/ml (0,3ml/kg)<br> <br> Procedure: tissue infiltration : placebo<br> <br> |
| Active Comparator: tissue infiltration<br>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 | Procedure: tissue infiltration : Ropivacaine 2mg/ml (0,3ml/kg)<br> <br> Procedure: serratus plane bloc : placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative chronic pain assessed using the DN4 questionnaire | DN4 questionnaire | 3 months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative acute pain | Visual analogue scale (V.A.S.) | day 1, day 2, day 3 postoperative | 
| morphine consumption |  | day 1, day 2, day 3 postoperative |