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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Mastectomy; Lymphedema

Intervention / Treatment
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* Procedure: SAPB
* Procedure: Local Injection Anesthesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |