Superficial Serratus Plane Block for Modified Radical Mastectomy and Axillary Lymph Node Disection

Study Overview
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Brief Summary
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Breast cancer is the most common type of cancer in women. Mastectomy and axillary lymph node disection are commonly performed as part of the cancer management. This surgery can cause significant postoperative pain. The serratus plane block (SPB) has been described for analgesia of the hemithorax and reported for many cases such as thoracoscopy, shoulder arthroscopy, breast surgery and axillary lymph node dissections. Serratus plane block may be a viable alternative to current regional anaesthetic techniques such as thoracic paravertebral and central neuraxial blockade. The aim of this study is to determine effectiveness of ultrasound guided superficial serratus plane block in patients undergoing modified radical mastectomy and axillary lymph node dissection surgery.

Official Title
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Analgesic Efficiency of Superficial Serratus Plane Block for Modified Radical Mastectomy and Axillary Lymph Node Disection: Randomized Controlled Study

Conditions
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Postoperative Analgesia, Pain, Postoperative, Opioid Consumption

Intervention / Treatment
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* Drug: Bupivacaine
* Drug: Saline
* Device: Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologist's physiologic state I-III patients undergoing Modified Radical Mastectomy and Axillary Lymph Node Disection Exclusion Criteria: chronic pain, bleeding disorders, renal or hepatic insufficiency,patients on chronic non-steroidal anti-inflammatory medications

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Group SPB<br>Ultrasound guided serratus plane block with 30 ml %0,25 bupivacaine | Drug: Bupivacaine<br>* 30 ml %0,25 bupivacaine<br>Device: Ultrasound<br>* Ultrasound guided block<br>|
| Active Comparator: Group Control<br>Ultrasound guided sham block with 2 ml saline subcutaneously | Drug: Saline<br>* 2 ml saline subcutaneously<br>Device: Ultrasound<br>* Ultrasound guided block<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Consumption | First 24 hours total fentanyl consumption with patient controlled analgesia | First 24 hours total opioid consumption | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog pain score | Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at first hour postoperatively. | postoperative first hour | 
| Visual analog pain score | Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at second hour postoperatively. | postoperative second hour | 
| Visual analog pain score | Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 4th hour postoperatively. | postoperative 4th hour | 
| Visual analog pain score | Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 8th hour postoperatively. | postoperative 8th hour | 
| Visual analog pain score | Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 12th hour postoperatively. | postoperative 12th hour | 
| Visual analog pain score | Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 24th hour postoperatively. | postoperative 24th hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Superficial Serratus Plane Block, Modified Radical Mastectomy, Axillary Lymph Node Disection, bupivacaine