PECBLOCK for the Treatment of Pain After Breast Surgery

Pain Clinical Trial

— PECBLOC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01670448
• Other study ID #: CE12.231
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Pain

Intervention

Procedure:
• PECBLOCK under echoguidance
Performance of block under echography

Locations

Country	Name	City	State
Canada	CHUM	Montreal	Quebec
France	University Hospital, Limoges	Limoges

Sponsors (2)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)	University Hospital, Limoges

Countries where clinical trial is conducted

Canada,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total sufentanil consumption during surgery	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)
Other	Assess any complication from PECBLOCK	Cardiovascular collapse, anaphylactic shock, hematoma, bleeding..?	first 24 hours post surgery
Primary	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	Total morphine consumption in the recovery room	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))