PECBLOCK for the Treatment of Pain After Breast Surgery (PECBLOC)

October 2, 2019 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

The Pectoral Nerve Block (PECBLOCK) for the Treatment of Pain After Breast Cancer Surgery.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2W 1T8
        • CHUM
  • France
      • Limoges, France, 87042
        • University Hospital, Limoges

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PECBLOCK performed with bupivacaine
Active drug given through PECBLOCK in these patients.
Procedure: PECBLOCK under echoguidance
Performance of block under echography
Placebo Comparator: PECBLOCK performed with NaCl 0.9%
Placebo drug given through PECBLOCK in these patients
Procedure: PECBLOCK under echoguidance
Performance of block under echography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score at rest in the recovery room
Time Frame: 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
30 min after entering the recovery room or just before morphine administration if needed

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total morphine consumption in the recovery room
Time Frame: 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
in the recovery room before discharge (after 1 h on average))

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total sufentanil consumption during surgery
Time Frame: at the end of surgery (1-2 h on average)
When surgery is over, 1-2 h on average depending if it is a tumorectomy or a mastectomy, the total sufentanil consumption in micrograms during surgery is recorded.
at the end of surgery (1-2 h on average)
Assess any complication from PECBLOCK
Time Frame: first 24 hours post surgery
Cardiovascular collapse, anaphylactic shock, hematoma, bleeding..?
first 24 hours post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborators

University Hospital, Limoges

Investigators

  • Principal Investigator: Jérôme Cros, MD, CHU Limoges
  • Principal Investigator: Pierre Beaulieu, MD, CHUM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

August 17, 2012

First Submitted That Met QC Criteria

August 20, 2012

First Posted (Estimate)

August 22, 2012

Study Record Updates

Last Update Posted (Actual)

October 3, 2019

Last Update Submitted That Met QC Criteria

October 2, 2019

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CE12.231

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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