PECBLOCK for the Treatment of Pain After Breast Surgery

Phase 1

• Conditions: Pain; MedDRA version: 18.0 Level: SOC Classification code 10022117 Term: Injury, poisoning and procedural complications System Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-002764-12-FR
• Lead Sponsor: niversity Hospital, Limoges

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-25
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 128

Inclusion Criteria

- women aged 18-85 years old
- patients ASA status I-III
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 96
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32

Exclusion Criteria

- refusal of the PECBLOCK
- allergy to a drug used in the protocol (local anesthetic)
- patients with chronic pain before the surgery

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Estimate the analgesic efficiency of the pectoral block;<br> Secondary Objective: - Estimate the scores of pain at the rest and at the mobilization for the post-operative period. <br> - To compare the consumption of morphine at the post-operative period. <br> - To compare the consumption of sufentanil during the surgery<br> - To compare the consumption of morphine in the service. <br> - To compare the incidence accumulated by nausea and vomitings.<br> ;Primary end point(s): Pain score at rest in the recovery room ;Timepoint(s) of evaluation of this end point: 30 min after entering the recovery room or just before morphine administration if needed.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Total morphine consumption in the recovery room. ;Timepoint(s) of evaluation of this end point: In the recovery room before discharge (after 1 h on average)