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

Phase 4

Recruiting

• Conditions: Mastectomy; Lymphedema
• Interventions: Procedure: SAPB; Procedure: Local Injection Anesthesia

• Registration Number: NCT04756791
• Lead Sponsor: Universitair Ziekenhuis Brussel

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.

Study Timeline

• Study First Submitted: 2021-02-11
• Study First Submitted QC: 2021-02-11
• Study First Posted: 2021-02-16
• Study Start: 2021-06-16
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-10
• Last Update Posted: 2023-05-11
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Serratus anterior plane block	SAPB	Patients receive a SAPB with ropivacaine placed by anesthesiologist.
Local infiltration anesthesia	Local Injection Anesthesia	Patients will receive local infiltration anesthesia with ropivacaine placed by surgeon.

Primary Outcome Measures

Name	Time	Method
The use of opioids in the postoperative period	24 hours	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

Name	Time	Method
Numerical Pain Rating Scale	24 hours	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	24 hours	How much can the arm be mobilized of the patients? 3 groups: 1: restricted, 2: fair mobilization and 3. free mobilization

Trial Locations

Locations (1)

UZ Brussel; 🇧🇪 Jette, Brussel, Belgium