Serratus Plane Block For Breast Reduction Surgery

Study Overview
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Brief Summary
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Serratus plane block was first described in 2013 by Blanco and designed to primarily block the thoracic intercostal nerves. And this block provides sufficient analgesia lateral anterior and posterior part of thoracic wall.Increased use of ultrasound guidance for regional anesthesia in recent years has led to definition of thoracic wall PECs blocks by Blanco. The Serratus plain block (SPB), providing wider analgesia, with easier application and less adverse effects than neuroaxial blocks, has been defined after these blocks and has taken its place in the literature.In spite of the insufficient randomized clinical trials in the literature, SPB has been reported for many cases such as thoracoscopy, shoulder arthroscopy, breast surgery and axillary lymph node dissections, and the results are promising. The aim of this study is to determine effectiveness of ultrasound guided bilateral serratus plane block in patients undergoing breast reduction surgery. Main outcome measures: The primary endpoint is postoperative opioid consumption. Secondary endpoints are visual analogue pain scores, opioid related side effects.

Official Title
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The Effects of Bilateral Serratus Plane Block on Postoperative Opioid Consumption After Breast Reduction Surgery

Conditions
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Pain Management

Intervention / Treatment
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* Drug: Bupivacaine
* Drug: Saline


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 breast reduction surgery Exclusion Criteria: chronic pain bleeding disorders renal or hepatic insufficiency patients on chronic non-steroidal anti-inflammatory medications emergency cases

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: ultrasound guided serratus plane block<br>Bilateral ultrasound guided serratus plane block with 30 ml %0,25 bupivacaine | Drug: Bupivacaine<br>* 30 ml %0,25 bupivacaine bilaterally<br>|
| Placebo Comparator: ultrasound guided sham block<br>Bilateral ultrasound guided sham block with 2 ml saline subcutaneously | Drug: Saline<br>* 2 ml saline subcutaneously bilaterally<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 8thhour | 
| 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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Postoperative Analgesia, Ultrasound guided serratus plane block