Erector Spina Plane Block vs Serratus Anterior Plane Block for Postoperative Mastectomy Pain

Study Overview
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Brief Summary
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The aim of this study is to compare the efficiency of serratus anterior plane block and erector spina plane block on analgesic consumption, postoperative pain and patient's satisfaction and recovery quality in patients undergoing mastectomy.

Detailed Description
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Mastectomy may cause severe postoperative pain. There are several analgesic methods for postoperative pain management. Serratus anterior plane (SAP) block is an interfascial plane block which is performed into the fascial plane of serratus anterior muscle. It provides effective analgesia in anterior, posterior and lateral dermatomes of thorax. There are several studies about its analgesic efficacy for mastectomy pain. The erector spina plane (ESP) block is another novel plan block which provides analgesia at multi-dermatomal area of the anterior, posterior, and lateral thoracic and abdominal walls. There are some studies about its effectiveness for postoperative mastectomy pain management. However, according to our best knowledge, there is no literature comparing the efficacy of ESP block and SAP block patients undergoing mastectomy.

Official Title
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Comparison of Erector Spina Plane Block and Serratus Anterior Plane Block in Patients Undergoing Mastectomy

Conditions
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Mastectomy, Pain, Postoperative, Recovery Period, Anesthesia

Intervention / Treatment
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* Procedure: serratus anterior plane block
* Procedure: erector spina plane block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American society of score anesthesiologist I-II-III Elective modified radical mastectomy 18-65 years old Exclusion Criteria: neurological disease coagulopathy disease or using anticoagulants non-cooperative allergic to one of the drugs used in the study recurrent breast cancer body mass index is above 35

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: serratus anterior plane block<br>The serratus anterior plane block will be performed under ultrasound guidance in the preoperative term. Tramadol will be administered via patient controlled analgesia (PCA) device at 20 mg bolus dose with 10 min. lockout time without basal infusion dose. | Procedure: serratus anterior plane block<br>* ultrasound guided serratus anterior plane block will be done with % 0.25 bupivacaine.<br>|
| Active Comparator: erector spina plane block<br>The erector spina plane block will be performed under ultrasound guidance in the preoperative term. Tramadol will be administered via PCA device at 20 mg bolus dose with 10 min. lockout time without basal infusion dose. | Procedure: erector spina plane block<br>* ultrasound guided erector spina plane block will be done with % 0.25 bupivacaine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic consumption | Tramadol dose will be calculated as milligram | From at the end of surgery (at postoperative 0th hour) to postoperative 24th hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain intensity | Numeric rating scale which is 0 to 10 will be recorded.In this scale, 0 is no pain, 10 is the worst pain. | At 0,2,4,6,12,24th hours after surgery | 
| Quality of recovery | Quality of recovery (QoR-40) questionaire will be recorded. The QoR-40 is a questionaire which measures of five dimensions of health: patient support, comfort, emotions, physical independence, and pain on a five-point likert scale. QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery) | At postoperative 24th hours | 
| The number of patients with perioperative side effects | The number of patients with perioperative side effects(emesis, nausea, local anesthetic toxicity, pneumothorax, local hematoma) will be recorded | From 30 minute before surgery to postoperative 24th hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain Management, Quality of Healthcare