PECBLOCK for the Treatment of Pain After Breast Surgery

Not Applicable

Completed

• Conditions: Cancer; Pain
• Interventions: Procedure: PECBLOCK under echoguidance

• Registration Number: NCT01670448
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Brief Summary

Pain after breast cancer surgery could be severe and about 1/3 of patients will develop chronic pain. The PECBLOCK is the injection of local anesthetics between the two pectoral muscles to block pectoral nerves and intercostal nerves innervating the breast. The aim of this study is to evaluate the efficacy of the PECBLOCK performed under echoguidance in minor and major breast surgery. The prevention of chronic pain following surgery will also be evaluated.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-17
• Study First Submitted QC: 2012-08-20
• Study First Posted: 2012-08-22
• Study Start: 2014-01
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-07
• Last Update Submitted: 2019-10-02
• Last Update Posted: 2019-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 128

Inclusion Criteria

• women aged 18-85 yrs old
• patients ASA status I-IV

Exclusion Criteria

• refusal of the PECBLOCK
• allergy to a drug used in the protocol (local anesthetic)
• patients with chronic pain before the surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PECBLOCK performed with bupivacaine	PECBLOCK under echoguidance	Active drug given through PECBLOCK in these patients.
PECBLOCK performed with NaCl 0.9%	PECBLOCK under echoguidance	Placebo drug given through PECBLOCK in these patients

Primary Outcome Measures

Name	Time	Method
Pain score at rest in the recovery room	30 min after entering the recovery room or just before morphine administration if needed	Using a 0-10 verbal numerical scale where 0 is no pain and 10 the worst pain imaginable

Secondary Outcome Measures

Name	Time	Method
Total morphine consumption in the recovery room	in the recovery room before discharge (after 1 h on average))	When surgery is over and the patient is brought to the recovery room, the total morphine consumption in mg used in the recovery (for pain less than 4/10) is recorded

Trial Locations

Locations (2)

University Hospital, Limoges; 🇫🇷 Limoges, France

CHUM; 🇨🇦 Montreal, Quebec, Canada