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PECBLOCK for the Treatment of Pain After Breast Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor:
Collaborator:
University Hospital, Limoges
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01670448
First received: August 17, 2012
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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
Cancer
Pain
Procedure: PECBLOCK under echoguidance

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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)) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Cardiovascular collapse, anaphylactic shock, hematoma, bleeding..?


Estimated Enrollment: 142
Study Start Date: January 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01670448

Contacts
Contact: Jérome Cros, MD (33) 555-05-6300 jeromemcros@yahoo.fr
Contact: Pierre Beaulieu, MD, PhD (1) 514-890-800 ext 14570 pierre.beaulieu@umontreal.ca

Locations
Canada, Quebec
CHUM Recruiting
Montreal, Quebec, Canada, H2W 1T8
Principal Investigator: Pierre Beaulieu, MD, PhD         
France
University Hospital, Limoges Recruiting
Limoges, France, 87042
Contact: Jérome Cros, MD    (33) 555-05-6300    jeromemcros@yahoo.fr   
Principal Investigator: Jérome Cros, MD         
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
  More Information

No publications provided

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT01670448     History of Changes
Other Study ID Numbers: CHUMPECBLOC
Study First Received: August 17, 2012
Last Updated: July 16, 2014
Health Authority: Canada: Ethics Review Committee
France: Committee for the Protection of Personnes

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

ClinicalTrials.gov processed this record on November 25, 2014