The Analgesic Efficacy of the Pectoral Block After Mastectomy

June 7, 2019 updated by: Eric Albrecht, Centre Hospitalier Universitaire Vaudois
Unilateral mastectomy is associated with moderate to severe postoperative pain. A new regional anaesthetic technique has been recently described, call the PEC block. This technique consists of injecting local anaesthetic between different muscles of the chest in order to relieve postoperative pain. The investigators aim to verify that this technique has a clinical relevant postoperative analgesic effect. For that purpose, the investigators will randomise 50 patients scheduled to undergo unilateral mastectomy into two groups: one group will receive a PEC block after the induction of the general anaesthesia under ultrasound guidance, while the other group will not have this regional procedure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • Lausanne University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • ASA physical status I-III
  • Age ≥ 18
  • Patients undergoing unilateral mastectomy

Exclusion Criteria:

  • Contraindications to regional block
  • Pregnancy
  • Inability to give informed consent
  • History of alcohol or drug dependence/abuse
  • History of long term opioid intake or chronic pain disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PEC block
Ultrasound-guided PEC block after induction of general anaesthesia.
Procedure: PEC block + General anaesthesia
Patients will receive an ultrasound-guided PEC block after the induction of general anaesthesia.
Sham Comparator: Control
No ultrasound-guided PEC block; only general anaesthesia will be provided.
Procedure: General anaesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intravenous morphine consumption during the first 24 postoperative hours (mg)
Time Frame: Postoperative day 1
Postoperative day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intravenous morphine consumption on postoperative day 2 (mg)
Time Frame: Postoperative day 2
Postoperative day 2
Intravenous morphine consumption in phase 1 recovery (mg)
Time Frame: 2 postoperative hours
2 postoperative hours
Pain scores at rest in phase 1 recovery (visual analogue scale, 0 - 10)
Time Frame: 2 postoperative hours
(visual analogue scale, 0 - 10)
2 postoperative hours
Pain scores at rest on postoperative day 1 (visual analogue scale, 0 - 10)
Time Frame: Postoperative day 1
Visual analogue scale, 0 - 10)
Postoperative day 1
Pain scores at rest on postoperative day 2 (visual analogue scale, 0 - 10)
Time Frame: Postoperative day 2
Visual analogue scale, 0 - 10)
Postoperative day 2
Postoperative nausea and vomiting (yes/no)
Time Frame: Postoperative day 1
Postoperative day 1
Postoperative nausea and vomiting (yes/no)
Time Frame: Postoperative day 2
Postoperative day 2
Pruritus (yes/no)
Time Frame: Postoperative day 1
Postoperative day 1
Pruritus (yes/no)
Time Frame: Postoperative day 2
Postoperative day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Vaudois

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

April 1, 2019

Study Registration Dates

First Submitted

September 26, 2016

First Submitted That Met QC Criteria

September 26, 2016

First Posted (Estimate)

September 27, 2016

Study Record Updates

Last Update Posted (Actual)

June 10, 2019

Last Update Submitted That Met QC Criteria

June 7, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CER 2016-01413

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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