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

Free University of Brussels (ULB)

Status: Unknown

Conditions: Postoperative Complication; Chronic Pain; Breast/Surgery

Treatments: Procedure: serratus plane bloc : placebo; Procedure: tissue infiltration : placebo; Procedure: tissue infiltration : Ropivacaine 2mg/ml (0,3ml/kg); Procedure: serratus plane bloc : Ropivacaine 2mg/ml (0,3ml/kg)

Study type: Interventional

Funder types: Other

Identifiers

NCT02838173

B406201628750

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 110 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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110 participants in 2 patient groups

SPB

Experimental group

Description:

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

Treatment:

Procedure: tissue infiltration : placebo

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

tissue infiltration

Active Comparator group

Description:

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

Treatment:

Procedure: serratus plane bloc : placebo

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