The Analgesic Efficacy of the Pectoral Block After Mastectomy

Not Applicable

Completed

• Conditions: Analgesia
• Interventions: Procedure: General anaesthesia; Procedure: PEC block + General anaesthesia

• Registration Number: NCT02916381
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-26
• Study First Submitted QC: 2016-09-26
• Study First Posted: 2016-09-27
• Study Start: 2017-01
• Primary Completion: 2018-10
• Study Completion: 2019-04
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-07
• Last Update Posted: 2019-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	General anaesthesia	No ultrasound-guided PEC block; only general anaesthesia will be provided.
PEC block	PEC block + General anaesthesia	Ultrasound-guided PEC block after induction of general anaesthesia.

Primary Outcome Measures

Name	Time	Method
Intravenous morphine consumption during the first 24 postoperative hours (mg)	Postoperative day 1

Secondary Outcome Measures

Name	Time	Method
Intravenous morphine consumption on postoperative day 2 (mg)	Postoperative day 2
Intravenous morphine consumption in phase 1 recovery (mg)	2 postoperative hours
Pain scores at rest on postoperative day 1 (visual analogue scale, 0 - 10)	Postoperative day 1	Visual analogue scale, 0 - 10)
Pain scores at rest on postoperative day 2 (visual analogue scale, 0 - 10)	Postoperative day 2	Visual analogue scale, 0 - 10)
Postoperative nausea and vomiting (yes/no)	Postoperative day 2
Pruritus (yes/no)	Postoperative day 2
Pain scores at rest in phase 1 recovery (visual analogue scale, 0 - 10)	2 postoperative hours	(visual analogue scale, 0 - 10)

Trial Locations

Locations (1)

Lausanne University Hospital; 🇨🇭 Lausanne, Vaud, Switzerland