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

This study has been completed.
University Hospital, Limoges
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM) Identifier:
First received: August 17, 2012
Last updated: August 31, 2015
Last verified: July 2015
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.

Condition Intervention
Procedure: PECBLOCK under echoguidance

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Pectoral Nerve Block (PECBLOCK) for the Treatment of Pain After Breast Cancer Surgery.

Resource links provided by NLM:

Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Other Outcome Measures:
  • 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.

  • Assess any complication from PECBLOCK [ Time Frame: first 24 hours post surgery ]
    Cardiovascular collapse, anaphylactic shock, hematoma, bleeding..?

Enrollment: 128
Study Start Date: January 2014
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01670448

Canada, Quebec
Montreal, Quebec, Canada, H2W 1T8
University Hospital, Limoges
Limoges, France, 87042
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
University Hospital, Limoges
Principal Investigator: Jérôme Cros, MD CHU Limoges
Principal Investigator: Pierre Beaulieu, MD CHUM
  More Information

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM) Identifier: NCT01670448     History of Changes
Other Study ID Numbers: CE12.231
Study First Received: August 17, 2012
Last Updated: August 31, 2015

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Postoperative pain
Chronic pain prevention
Regional anesthesia
Mastectomy processed this record on May 23, 2017