Combined PECS II and Transeversus Thoracic Plane Blocks Vs Serratus Anterior Plane Block in Modified Radical Mastectomy

Study Overview
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Brief Summary
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The aim of this study is to evaluate the analgesic efficacy of combined ultrasound (US)-guided pectoral nerve (PECS) block II and transversus thoracic plane (TTP) block versus US-guided serratus anterior plane (SAP) block in female patients undergoing modified radical mastectomy.

Official Title
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Analgesic Efficacy of Combined Ultrasound-Guided PECS II and Transeversus Thoracic Plane Blocks Versus Ultrasound-Guided Serratus Anterior Plane Block in Modified Radical Mastectomy: A Prospective Randomized Study

Conditions
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Ultrasound-Guided, Transeversus Thoracic Plane Blocks, Pectoral Nerve (PECS) Block, Serratus Anterior Plane Block, Modified Radical Mastectomy

Intervention / Treatment
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* Procedure: Pectoral nerve (PECS) block -transversus thoracic plane (TTP) block
* Procedure: Serratus anterior plane (SAP) block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients Aged 21-60 years ASA physical status I, II Scheduled for unilateral modified radical mastectomy Exclusion Criteria: Patient refusal. Known hypersensitivity to local anesthetics. Body mass index > 35 kg /m2. Uncooperative or psychiatric patients. Infection at the injection site. Coagulation disorder.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 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 |
| --- | --- |
| Experimental: Group I (pectoral nerve (PECS) block -transversus thoracic plane (TTP) block group)<br>Patients will receive unilateral US-guided PECS II block and TTP block on the side of the operation after induction of general anesthesia. | Procedure: Pectoral nerve (PECS) block -transversus thoracic plane (TTP) block<br>* Patients will receive unilateral US-guided PECS II block and TTP block on the side of the operation after induction of general anesthesia.<br>|
| Experimental: Group II (serratus anterior plane (SAP) block group)<br>Patients will receive US-guided SAP block after induction of general anesthesia. | Procedure: Serratus anterior plane (SAP) block<br>* Patients will receive US-guided SAP block after induction of general anesthesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total amount rescue analgesic consumption (morphine) in the first 24 hours postoperatively. | Rescue analgesia in the form of morphine (3mg IV) will be given if the VAS is ≥ 40, repeated with lock out interval of 5 min guided with the occurrence of complications till the VAS is decreased to less than 40. | First 24 hours postoperatively. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The degree of postoperative pain | Postoperative pain will be assessed by Visual Analog scale (VAS) on admission to Post-Anesthesia Care unit (PACU) and at 30 minutes and then 1,2,4,6,12,18 and 24 hours postoperative. VAS (0-100; where 0 represents no pain and 100 represents the worst pain). | First 24 hours postoperatively. | 
| Time to first rescue analgesia request. | Rescue analgesia in the form of morphine (3mg IV) will be given if the VAS is ≥ 40, repeated with lock out interval of 5 min guided with the occurrence of complications till the VAS is decreased to less than 40. | First 24 hours postoperatively. | 
| Intraoperative fentanyl consumption. | Additional boluses of fentanyl 0.5 µg /kg will be administered in case of inadequate analgesia that defined as increase of heart rate (HR) and /or mean arterial blood pressure (MAP) more than 20 % from baseline | Intraoperative |