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

Universitair Ziekenhuis Brussel

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Mastectomy; Lymphedema

Interventions

SAPBPROCEDURE

local anesthetic is injected between the serratus anterior and latissimus dorsi muscles.

Local Injection AnesthesiaPROCEDURE

Anesthesia is injected directly into the tissue that is will be numbing.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

UZ Brussel

Jette, Brussels Capital, Belgium

Outcomes

Primary Outcomes

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.

Time frame: 24 hours

Secondary Outcomes

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.

Time frame: 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

Time frame: 24 hours

Data from ClinicalTrials.gov

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