The Analgesic Efficacy of the Pectoral Block After Mastectomy

Vaud University Hospital Center

Status: Completed

Conditions: Analgesia

Treatments: Procedure: General anaesthesia; Procedure: PEC block + General anaesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT02916381

CER 2016-01413

Details and patient eligibility

About

Unilateral mastectomy is associated with moderate to severe postoperative pain. A new regional anaesthetic technique has been recently described, call the PEC block. This technique consists of injecting local anaesthetic between different muscles of the chest in order to relieve postoperative pain. The investigators aim to verify that this technique has a clinical relevant postoperative analgesic effect. For that purpose, the investigators will randomise 50 patients scheduled to undergo unilateral mastectomy into two groups: one group will receive a PEC block after the induction of the general anaesthesia under ultrasound guidance, while the other group will not have this regional procedure.

Enrollment: 50 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ASA physical status I-III
• Age ≥ 18
• Patients undergoing unilateral mastectomy

Exclusion criteria

• Contraindications to regional block
• Pregnancy
• Inability to give informed consent
• History of alcohol or drug dependence/abuse
• History of long term opioid intake or chronic pain disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

PEC block

Experimental group

Description:

Ultrasound-guided PEC block after induction of general anaesthesia.

Treatment:

Procedure: PEC block + General anaesthesia

Control

Sham Comparator group

Description:

No ultrasound-guided PEC block; only general anaesthesia will be provided.

Treatment:

Procedure: General anaesthesia