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

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.

Study Overview

• Status: Withdrawn
• Conditions: Mastectomy; Lymphedema
• Intervention / Treatment: Procedure: Local Injection Anesthesia; Procedure: SAPB

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.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Brussels Capital
    • Jette, Brussels Capital, Belgium, 1090
      • UZ Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Local infiltration anesthesia; Patients will receive local infiltration anesthesia with ropivacaine placed by surgeon.	Procedure: Local Injection Anesthesia; Anesthesia is injected directly into the tissue that is will be numbing.
Experimental: Serratus anterior plane block; Patients receive a SAPB with ropivacaine placed by anesthesiologist.	Procedure: SAPB; local anesthetic is injected between the serratus anterior and latissimus dorsi muscles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours
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	24 hours

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: February 11, 2021
• First Submitted That Met QC Criteria: February 11, 2021
• First Posted (Actual): February 16, 2021

Study Record Updates

• Last Update Posted (Estimated): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Hemic and Lymphatic Diseases; Lymphedema; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: SAPLIA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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