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Large-scale Prospective Double-blind Randomized Controlled Trial of Pecs II Block for Breast Surgery

NCT02544282 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2016-07-13

No results posted yet for this study

Summary

In this prospective trial, Stage 1-3 patients having mastectomies or isolated lumpectomy with axillary node dissection will be randomly assigned to general anesthesia with opioids combined with a Pecs II block or to general anesthesia with opioids combined with a placebo Pecs II block. Participants will be followed postoperatively during their entire hospital stay to determine the effectiveness of Pecs II block and opioids versus placebo Pecs II block and opioids as postoperative pain treatment.

Conditions

  • Pain, Postoperative
  • Postoperative Nausea and Vomiting

Interventions

DRUG

Levobupivacaine

Pecs II Block

DRUG

NaCl 0.9%

Placebo Pecs II block

DRUG

Sevoflurane

General Anesthesia

DRUG

Propofol

General Anesthesia

DRUG

Sufentanil

General Anesthesia

DRUG

Atracurium

General Anesthesia

DRUG

Paracetamol

Pain Relief

DRUG

Tramadol

Pain Relief

DRUG

Piritramide

Pain Relief

Sponsors & Collaborators

  • GZA Ziekenhuizen Campus Sint-Augustinus

    lead OTHER

Principal Investigators

  • Barbara JB Versyck, MD · GZA Ziekenhuizen Campus Sint-Augustinus

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs

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 NCT02544282 on ClinicalTrials.gov