Serratus Plane Block for the Prevention of Chronic Pain After Breast Cancer Surgery

July 19, 2016 updated by: Céline Boudart, Erasme University Hospital
This study compare the "Serratus block plane" (SPB) and the local infiltration of the tissue in the prevention of acute and chronic pain after breast cancer surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Chronic pain after breast surgery may be severe, often requiring the use of morphine. The incidence of chronic pain varies from 27 to 50% depending on definitions.

The infiltration of tissues by a local anesthetic is a simple, fast and low risk technique but of limited effectiveness.

Serratus the flat block, performed under ultrasound guidance, is minimally invasive and easy to perform. It allows anesthesia and analgesia to an extended part of the anterolateral chest wall and the axilla. This regional anesthesia technique provides good analgesia during and after breast surgery, but remains to be evaluated; beyond perioperative analgesia, the benefit-risk, post operative rehabilitation, and the impact on ambulatory and on chronic pain are fundamental objectives.

Study Type

Interventional

Enrollment (Anticipated)

110

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.

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:

  • Women scheduled for elective breast neoplasm surgery
  • Of ASA classification 1, 2 or 3
  • Patients who provide written informed consent

Exclusion Criteria:

  • Minor patients
  • Patients refusing to sign the consent
  • Patients included in another protocol within 3 months
  • Pregnant or lactating patients
  • Patients with history of allergy to local anesthetics (Ropivacaine)
  • Patients with contraindication to regional anesthesia (coagulopathy, local infection ...)
  • Patients with history of prior breast surgery (excluding diagnostic biopsy)
  • Patients with history of chronic pain
  • Patients with a history of psychiatric 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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SPB
Serratus Plane Bloc with Ropivacaine 2mg/ml (0,3ml/kg) and tissue infiltration with placebo made once, by the anesthetist in the operating theater before surgical incision
Procedure: serratus plane bloc : Ropivacaine 2mg/ml (0,3ml/kg)
Procedure: tissue infiltration : placebo
Active Comparator: tissue infiltration
tissue infiltration with Ropivacaine 2mg/ml (0,3ml/kg) and Serratus Plane Bloc with placebo made once, by the anesthetist in the operating theater before surgical incision
Procedure: tissue infiltration : Ropivacaine 2mg/ml (0,3ml/kg)
Procedure: serratus plane bloc : placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative chronic pain assessed using the DN4 questionnaire
Time Frame: 3 months postoperative
DN4 questionnaire
3 months postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative acute pain
Time Frame: day 1, day 2, day 3 postoperative
Visual analogue scale (V.A.S.)
day 1, day 2, day 3 postoperative
morphine consumption
Time Frame: day 1, day 2, day 3 postoperative
day 1, day 2, day 3 postoperative

Other Outcome Measures

Outcome Measure
Time Frame
length of stay in the Postoperative Acute Care Unit
Time Frame: through study completion
through study completion
length of stay in hospital
Time Frame: through study completion
through study completion

Collaborators and Investigators

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

Sponsor

Erasme University Hospital

Investigators

  • Study Director: Luc Van Obbergh, MD PhD, Erasme Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

March 1, 2018

Study Registration Dates

First Submitted

June 30, 2016

First Submitted That Met QC Criteria

July 19, 2016

First Posted (Estimate)

July 20, 2016

Study Record Updates

Last Update Posted (Estimate)

July 20, 2016

Last Update Submitted That Met QC Criteria

July 19, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B406201628750

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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