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

Primary Purpose

Breast/Surgery, Postoperative Complication, Chronic Pain

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

serratus plane bloc : Ropivacaine 2mg/ml (0,3ml/kg)

tissue infiltration : Ropivacaine 2mg/ml (0,3ml/kg)

serratus plane bloc : placebo

tissue infiltration : placebo

About this trial

This is an interventional prevention trial for Breast/Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SPB

tissue infiltration

Arm Description

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

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

Outcomes

Primary Outcome Measures

postoperative chronic pain assessed using the DN4 questionnaire

DN4 questionnaire

Secondary Outcome Measures

postoperative acute pain

Visual analogue scale (V.A.S.)

morphine consumption

Full Information

NCT ID

NCT02838173

First Posted

June 30, 2016

Last Updated

July 19, 2016

Sponsor

Erasme University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02838173

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Unknown status

Study Start Date

July 2016 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Erasme University Hospital

4. Oversight

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast/Surgery, Postoperative Complication, Chronic Pain

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SPB

Arm Type

Experimental

Arm Description

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

Arm Title

tissue infiltration

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

serratus plane bloc : Ropivacaine 2mg/ml (0,3ml/kg)

Intervention Type

Procedure

Intervention Name(s)

tissue infiltration : Ropivacaine 2mg/ml (0,3ml/kg)

Intervention Type

Procedure

Intervention Name(s)

serratus plane bloc : placebo

Intervention Type

Procedure

Intervention Name(s)

tissue infiltration : placebo

Primary Outcome Measure Information:

Title

postoperative chronic pain assessed using the DN4 questionnaire

Description

DN4 questionnaire

Time Frame

3 months postoperative

Secondary Outcome Measure Information:

Title

postoperative acute pain

Description

Visual analogue scale (V.A.S.)

Time Frame

day 1, day 2, day 3 postoperative

Title

morphine consumption

Time Frame

day 1, day 2, day 3 postoperative

Other Pre-specified Outcome Measures:

Title

length of stay in the Postoperative Acute Care Unit

Time Frame

through study completion

Title

length of stay in hospital

Time Frame

through study completion

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Céline Boudart, MD

Phone

3225553919

cboudart@ulb.ac.be

First Name & Middle Initial & Last Name or Official Title & Degree

Wendy Villareal Fernandez, MD

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Luc Van Obbergh, MD PhD

Organizational Affiliation

Erasme hospital

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

23923989

Citation

Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.

Results Reference

background

PubMed Identifier

23811426

Citation

Andreae MH, Andreae DA. Regional anaesthesia to prevent chronic pain after surgery: a Cochrane systematic review and meta-analysis. Br J Anaesth. 2013 Nov;111(5):711-20. doi: 10.1093/bja/aet213. Epub 2013 Jun 28.

Results Reference

background

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

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