PECBLOCK for the Treatment of Pain After Breast Surgery

NCT ID: NCT01670448

Last Updated: 2019-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PECBLOCK performed with bupivacaine

Active drug given through PECBLOCK in these patients.

Group Type ACTIVE_COMPARATOR

PECBLOCK under echoguidance

Intervention Type PROCEDURE

Performance of block under echography

PECBLOCK performed with NaCl 0.9%

Placebo drug given through PECBLOCK in these patients

Group Type PLACEBO_COMPARATOR

PECBLOCK under echoguidance

Intervention Type PROCEDURE

Performance of block under echography

Interventions

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PECBLOCK under echoguidance

Performance of block under echography

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Limoges

OTHER

Sponsor Role collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jérôme Cros, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Limoges

Pierre Beaulieu, MD

Role: PRINCIPAL_INVESTIGATOR

CHUM

Locations

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CHUM

Montreal, Quebec, Canada

Site Status

University Hospital, Limoges

Limoges, , France

Site Status

Countries

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Canada France

References

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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.

Reference Type DERIVED
PMID: 29672368 (View on PubMed)

Other Identifiers

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CE12.231

Identifier Type: -

Identifier Source: org_study_id

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