PECBLOCK for the Treatment of Pain After Breast Surgery
PECBLOC
The Pectoral Nerve Block (PECBLOCK) for the Treatment of Pain After Breast Cancer Surgery.
1 other identifier
interventional
128
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable cancer
Started Jan 2014
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2012
CompletedFirst Posted
Study publicly available on registry
August 22, 2012
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedOctober 3, 2019
July 1, 2015
1.4 years
August 17, 2012
October 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain score at rest in the recovery room
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 Outcomes (1)
Total morphine consumption in the recovery room
in the recovery room before discharge (after 1 h on average))
Other Outcomes (2)
Total sufentanil consumption during surgery
at the end of surgery (1-2 h on average)
Assess any complication from PECBLOCK
first 24 hours post surgery
Study Arms (2)
PECBLOCK performed with bupivacaine
ACTIVE COMPARATORActive drug given through PECBLOCK in these patients.
PECBLOCK performed with NaCl 0.9%
PLACEBO COMPARATORPlacebo drug given through PECBLOCK in these patients
Interventions
Performance of block under echography
Eligibility Criteria
You may qualify if:
- women aged 18-85 yrs old
- patients ASA status I-IV
You may not qualify if:
- refusal of the PECBLOCK
- allergy to a drug used in the protocol (local anesthetic)
- patients with chronic pain before the surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CHUM
Montreal, Quebec, H2W 1T8, Canada
University Hospital, Limoges
Limoges, 87042, France
Related Publications (1)
Cros J, Senges P, Kaprelian S, Desroches J, Gagnon C, Labrunie A, Marin B, Crepin S, Nathan N, Beaulieu P. Pectoral I Block Does Not Improve Postoperative Analgesia After Breast Cancer Surgery: A Randomized, Double-Blind, Dual-Centered Controlled Trial. Reg Anesth Pain Med. 2018 Aug;43(6):596-604. doi: 10.1097/AAP.0000000000000779.
PMID: 29672368DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jérôme Cros, MD
CHU Limoges
- PRINCIPAL INVESTIGATOR
Pierre Beaulieu, MD
CHUM
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2012
First Posted
August 22, 2012
Study Start
January 1, 2014
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
October 3, 2019
Record last verified: 2015-07