PECBLOCK for the Treatment of Pain After Breast Surgery

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) (Other)
• Overall Status: Completed
• CT.gov ID: NCT01670448
• Collaborator: University Hospital, Limoges (Other)
• Enrollment: 128
• Locations: 2
• Arms: 2
• Duration (Months): 17
• Patients Per Site: 64
• Patients Per Site Per Month: 3.8

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Jan 1, 2014
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pain score at rest in the recovery room [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 [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 [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 [first 24 hours post surgery]

   Cardiovascular collapse, anaphylactic shock, hematoma, bleeding..?

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1	CHUM	Montreal	Quebec	Canada	H2W 1T8
2	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
• ClinicalTrials.gov Identifier: NCT01670448
• Other Study ID Numbers: CE12.231
• First Posted: Aug 22, 2012
• Last Update Posted: Oct 3, 2019
• Last Verified: Jul 1, 2015

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

Study Results

No Results Posted as of Oct 3, 2019