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Prospective Comparison of Single-Injection Serratus Anterior Plane Block With Ropivacaine Versus Local Infiltration of Anaesthetic After Breast Surgery (SAPLIA)

Primary Purpose

Mastectomy; Lymphedema

Status
Recruiting
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
SAPB
Local Injection Anesthesia
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mastectomy; Lymphedema

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-80 years.
  • Provision of signed informed consent prior to any study-specific procedure.
  • Patients who come to preoperative anesthesia consultation for their scheduled unilat-eral mastectomy.

Exclusion Criteria:

  • Age >80 years
  • History of chronic pain or drug treatment abuse
  • Depression, psychiatric morbidity or mal-adaptive coping behavior
  • Neuropathy
  • Severe anxiety or other mental ailment, taking drugs affecting their capacity to assess pain
  • Chronic or acute skin infection of the lateral thorax
  • Hypersensitivity to ropivacaine
  • Severe hepatic or renal disease
  • Refuse to participate to the study
  • Pregnancy

Sites / Locations

  • UZ BrusselRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Local infiltration anesthesia

Serratus anterior plane block

Arm Description

Patients will receive local infiltration anesthesia with ropivacaine placed by surgeon.

Patients receive a SAPB with ropivacaine placed by anesthesiologist.

Outcomes

Primary Outcome Measures

The use of opioids in the postoperative period
Patients receive a patient controlled intravenous anesthesia pump with morphine. We will be able to analyze the total amount of opioid requested by the patient.

Secondary Outcome Measures

Numerical Pain Rating Scale
Patients will be asked at 4 different time points the amount of pain they are feeling on a scale of 0 to 10. 0 meaning no pain and 10 meaning the worst pain imaginable.
Degree of arm mobilization
How much can the arm be mobilized of the patients? 3 groups: 1: restricted, 2: fair mobilization and 3. free mobilization

Full Information

First Posted
February 11, 2021
Last Updated
May 10, 2023
Sponsor
Universitair Ziekenhuis Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT04756791
Brief Title
Prospective Comparison of Single-Injection Serratus Anterior Plane Block With Ropivacaine Versus Local Infiltration of Anaesthetic After Breast Surgery
Acronym
SAPLIA
Official Title
Prospective Comparison of Single-Injection Serratus Anterior Plane Block With Ropivacaine Versus Local Infiltration of Anaesthetic After Breast Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitair Ziekenhuis Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate whether a serratus anterior plane block (SAPB) is more effective than a local infiltration anesthesia (LIA) with an equal dose and same anesthetic performed by the surgeon, as an adjuvant to treat postoperative pain after unilateral mastectomy.
Detailed Description
To evaluate whether a serratus anterior plane block (SAPB) is more effective than a local infiltration anesthesia (LIA) with an equal dose and same anesthetic performed by the surgeon, as an adjuvant to treat postoperative pain after unilateral mastectomy. Primary endpoint: the use of opioid's in the postoperative period. Secondary endpoint: Numerical Pain Rating Scale (NPRS) score recorded at the 2nd, 8th, 16th, 24th hour after surgery. 0 means no pain and 10 is the worst pain imaginable. In addition at the same time, we will look to the degree of arm mobilization where there will be 3 possible groups: 1. restricted, 2. fair mobilization and 3. free mobilization. There are 2 treatment arms: 1st arm is the standard therapy, namely the local infiltration anesthesia. 2nd arm is the experimental arm, namely the SAPB. Patients are randomised into each arm after screening.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Local infiltration anesthesia
Arm Type
Active Comparator
Arm Description
Patients will receive local infiltration anesthesia with ropivacaine placed by surgeon.
Arm Title
Serratus anterior plane block
Arm Type
Experimental
Arm Description
Patients receive a SAPB with ropivacaine placed by anesthesiologist.
Intervention Type
Procedure
Intervention Name(s)
SAPB
Intervention Description
local anesthetic is injected between the serratus anterior and latissimus dorsi muscles.
Intervention Type
Procedure
Intervention Name(s)
Local Injection Anesthesia
Intervention Description
Anesthesia is injected directly into the tissue that is will be numbing.
Primary Outcome Measure Information:
Title
The use of opioids in the postoperative period
Description
Patients receive a patient controlled intravenous anesthesia pump with morphine. We will be able to analyze the total amount of opioid requested by the patient.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Numerical Pain Rating Scale
Description
Patients will be asked at 4 different time points the amount of pain they are feeling on a scale of 0 to 10. 0 meaning no pain and 10 meaning the worst pain imaginable.
Time Frame
24 hours
Title
Degree of arm mobilization
Description
How much can the arm be mobilized of the patients? 3 groups: 1: restricted, 2: fair mobilization and 3. free mobilization
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-80 years. Provision of signed informed consent prior to any study-specific procedure. Patients who come to preoperative anesthesia consultation for their scheduled unilat-eral mastectomy. Exclusion Criteria: Age >80 years History of chronic pain or drug treatment abuse Depression, psychiatric morbidity or mal-adaptive coping behavior Neuropathy Severe anxiety or other mental ailment, taking drugs affecting their capacity to assess pain Chronic or acute skin infection of the lateral thorax Hypersensitivity to ropivacaine Severe hepatic or renal disease Refuse to participate to the study Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Evelien Vandeurzen
Phone
192 92 37
Email
evelien.vandeurzen@uzbrussel.be
Facility Information:
Facility Name
UZ Brussel
City
Jette
State/Province
Brussel
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evelien Vandeurzen, Master
Phone
024749237
Email
evelien.vandeurzen@uzbrussel.be
First Name & Middle Initial & Last Name & Degree
Philippe Kinnaer, MD
First Name & Middle Initial & Last Name & Degree
Brecht Bockstael, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Prospective Comparison of Single-Injection Serratus Anterior Plane Block With Ropivacaine Versus Local Infiltration of Anaesthetic After Breast Surgery

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