Comparing the Perioperative Analgesic Effect of Two Different Volumes of Local Anesthetic Solution in Erector Spinae Plane Block in Patients Undergoing Modified Radical Mastectomy

Study Overview
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Brief Summary
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The aim of this study is to compare and evaluate the analgesic effects of ultrasound-guided Erector Spinae Plane block using low volumes and high concentrations versus high volumes and low concentrations in patients undergoing MRM.

Detailed Description
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Multiple regional techniques have been developed in recent years for postoperative analgesia of breast surgery including ESPB aiming to be effective and associated with less complications when compared to the gold standard techniques (thoracic epidural analgesia or paravertebral block).. Ultrasound guided erector spinae plane (ESPB) block was described in 2016 as a novel regional anesthetic technique for acute and chronic thoracic pain, it has been used as a regional anesthetic technique for breast surgery based on case reports and case series. It is a paraspinal fascial plane block that involves injection of local anesthetic deep in the erector spinae muscle and superficial to the tips of the thoracic transverse processes. The site of injection is distant from the pleura, major blood vessels, and spinal cord; hence, performing the ESPB has relatively few contraindications. The injected local anesthetic drug blocks the ventral and dorsal rami of spinal nerves on the paravertebral area . Multiple studies have reported improved efficiency of interfascial blocks by increasing the volume of injection promoting better spread of local anesthesia. According to the authors best knowledge there is no studies comparing different volumes and concentration in ESPB in patients undergoing MRM This study aims to see the effect of fixing the drug mass of anaesthetic given in both groups, while altering the concentration of the anesthetic and total volume administered. One group will receive a lower concentration and higher volume, while the other will receive a higher concentration and lower volume.

Official Title
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Comparing the Perioperative Analgesic Effect of Two Different Volumes of Local Anesthetic Solution in Erector Spinae Plane Block in Patients Undergoing Modified Radical Mastectomy A Randomized Comparative Study

Conditions
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Comparing of 2 Different Volumes in ESPB in Patients Undergoing MRM

Intervention / Treatment
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* Drug: Group 1(low concentration-high volume bupivacaine US guided Erector Spinae Plane block)
* Drug: Group 2(high concentration-low volumecbupivacaine US guided Erector Spinae Plane block)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age starting from 18 to 60 years. Genders eligible for study: female sex. ASA II-III. Patients undergoing modified radical mastectomy. Body mass index (BMI) from 18.5 to 30 kg/m2. Exclusion Criteria: Patient refusal Known allergy to local anesthetics Bleeding disorders; platelets count <50,000, prothrombin concentration <60% or any coagulopathy disorder. Use of any anti-coagulants Inability to provide informed consent ASA IV Neurological disorders Patient with psychiatric disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: We hypothesize that high volume low concentration ultrasound-guided Erector Spinae Plane block is going to be more effective than low volume high concentration in patients undergoing MRM. Many authors advocate increasing the volume of injection in fascial plane blocks to allow better spread of local anesthetic according to multiple studies
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Patients will preoperatively receive low concentration-high volume U/S ESP block, and then the patient will be transferred to the operating room one syringe of 30ml bupivacaine 0.25% {15 ml bupivacaine 0.5% and 15ml normal saline}, for each patient. | Drug: Group 1(low concentration-high volume bupivacaine US guided Erector Spinae Plane block)<br>* Patients will preoperatively receive low concentration-high volume ultasound guided Erector Spinae Plane block, and then the patient will be transferred to the operating room ) one syringe of 30ml bupivacaine 0.25% {15 ml bupivacaine 0.5% and 15ml normal saline} for each patient<br>* Other names: Erector Spinae Plane Block with high volume-low concentration bupivacaine 0.25%;|
| Active Comparator: Group 2<br>Patients will preoperatively receive high concentration-low volume U/S ESP block block, and then the patient will be transferred to the operating room one syringe of 15 ml bupivacaine 0.5% {15 ml bupivacaine 0.5% }, for each patien). | Drug: Group 2(high concentration-low volumecbupivacaine US guided Erector Spinae Plane block)<br>* Patients will preoperatively receive high concentration-low volume ultasound guided Erector Spinae Plane block, and then the patient will be transferred to the operating room (one syringe of 15 ml bupivacaine 0.5% {15 ml bupivacaine 0.5% } for each patien).<br>* Other names: Erector Spinae Plane Block with low volume-high concentration bupivacaine 0.25%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total dose of morphine needed postoperatively | Total dose of morphine needed postoperatively | Through Study Completion Up to 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first rescue analgesia, starting after extubation | Time to first rescue analgesia, starting after extubation | Through Study Completion over the first 24 hours postoperative | 
| Duration of surgery | Duration of surgery | Through Study Completion 24 hours postoperative | 
| Blood loss, | Blood loss, | Through Study Completion,an average of 1day | 
| Total dose of fentanyl required intraoperative (including induction dose) | Total dose of fentanyl required intraoperative (including induction dose) | Through study completion,an average of 1day | 
| Pain score at 15, 30, 45 and 60 min., 3,6,12 and 24 h after surgery | Pain score at 15, 30, 45 and 60 min., 3,6,12 and 24 h after surgery | through study completion,an average of 1day | 
| Need for blood transfusion | Need for blood transfusion | Through Study Completion over the first 24 hours postoperative |