Regional Anesthesia for Modified Radical Mastectomy With Axillary Lymph Node Dissection

Study Overview
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Brief Summary
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local and regional anesthesia have been introduced with the goal of reducing the side effects associated with general anesthesia and IV opioid analgesia.our hypothesis is that ultrasound-guided interscalene brachial plexus block and erector spinae plane block will provide efficient surgical anesthesia and postoperative analgesia after modified radical mastectomy.

Detailed Description
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inadequate analgesia after modified radical mastectomy with axillary lymph node dissection may occur with most of regional anesthesia. pain in the axilla and upper limb is related to ineffective block of medial and lateral pectoral nerves as long thoracic and thoracodorsal nerves, leading to inadequate analgesia.The aim of this study is to evaluate the efficacy and safety of ultrasound-guided interscalene brachial plexus block and erector spinae plane block for providing surgical anesthesia and postoperative analgesia after modified radical mastectomy.

Official Title
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Feasibility of Combined Ultrasound Guided Interscalene Brachial Plexus Block and Erector Spinae Plane Block for Anesthesia in Modified Radical Mastectomy With Axillary Lymph Node Dissection: Pilot Study

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: regional anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients aged 40-85 years old American Society of Anesthesiologists' physical status III and IV Planned for modified radical mastectomy with axillary lymph node dissection Exclusion Criteria: Patient refusal Neurological or psychiatric disorders Local infection at injection site Spine or chest wall deformity Allergy or any contraindication to any of the study drugs Opioid or alcoholic addiction Chronic pain of any cause Uncooperative patients.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: regional anesthesia<br>combination of erector spinae plane block (ESPB) and interscalene block(IB).the ESPB will be performed using linear ultrasound transducer (Philips® cx 50 extreme edition, USA) and we will inject 20 ml solution(10 ml 0.5% bupivacaine, 5 ml 2% lidocaine, and 5 ml normal saline). the IB will be performed using the same ultrasound machine and injecting the same solution | Other: regional anesthesia<br>* combination of erector spinae plane block and interscalene block for anesthesia in modified radical mastectomy surgeries with axillary lymph node dissection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of the regional blocks | completion of the surgery without need of general anesthesia. | from the start to the end of the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of the blocks | Time to first request of rescue analgesia postoperative | 24- hours in the postoperative period | 
| Patients' satisfaction | degree of patients' satisfaction | 24-hours postoperative | 
| Any adverse events | postoperative nausea and vomiting, local anesthetic toxicity, desaturation, bradypnea,hypotension, bradycardia or somnolence | 24-hours postoperative |