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Double-blind Study to Assess effectIveness of Pectoral Nerves Block After Breast Surgery on Piritramide Consumption

NCT02655965 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2021-01-27

No results posted yet for this study

Summary

The aims of this study is to compare the effectiveness of pecs block associated to a general anesthesia in terms of Piritramide consumption compared with a general anaesthesia alone and the chronic pain incidence in patients that undergoing either a lumpectomy or a mastectomy associated with axillary dissection This is a double-blind, placebo controlled study that will randomise breast cancer subjects in 1:1 ratio to receive a "pecs block" of Ropivacaine 3.5 mg/ml and Clonidine 5 µg/ml (arm A) versus placebo (arm B).

Conditions

  • Locoregional Analgesia in Breast Surgery

Interventions

DRUG

Ropivacaine

Ropivacaine 3.5 mg/ml

DRUG

Clonidine

Clonidine 5µg/ml

DRUG

Sodium Chloride

Sodium Chloride 0.9 %

Sponsors & Collaborators

  • Jules Bordet Institute

    lead OTHER

Principal Investigators

  • Maurice Sosnowski, MD · Jules Bordet Institute

  • Kathleen Wiams, MD · Jules Bordet Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2019-11-30
Completion
2021-01-20

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02655965 on ClinicalTrials.gov