ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01670448
Recruitment Status : Completed
First Posted : August 22, 2012
Last Update Posted : September 1, 2015
Sponsor:
Collaborator:
University Hospital, Limoges
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cancer Pain Procedure: PECBLOCK under echoguidance Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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.
Study Start Date : January 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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 :
  1. 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:
  1. 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.

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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01670448


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

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT01670448     History of Changes
Other Study ID Numbers: CE12.231
First Posted: August 22, 2012    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: July 2015

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Postoperative pain
Chronic pain prevention
Regional anesthesia
Mastectomy