Efficacy and Safety of Dexmedetomidine Added to Modified Pectoral's Block in Breast Cancer Patients

Study Overview
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Brief Summary
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To Evaluate the effect of addition of Dexmedetomedine to ultrasound guided modified Pecs block on post operative analgesia & stress response in patient undergoing modified radical mastectomy.

Detailed Description
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60 patients (age ≥29 years) who scheduled for modified radical mastectomy surgery under general anesthesia. Group I (Bupivacaine group): patients underwent modified radical mastectomy were given preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine divided into 10 ml injected between the pectoralis muscles on the interfasial plane, and 20 ml injected between the Pectoralis minor muscle and the serratus muscle.Group II (Bupivacaine + Dexmedetomidine group) : preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine plus Dexmedetomidine (1 µg/kg) divided into 20 ml injected between the pectoralis muscles on the interfasial plane , and 10 ml injected between the Pectoralis minor muscle and the serratus muscle.

Official Title
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Efficacy and Safety of Dexmedetomidine Added to Modified Pectoral's Block in Patient Undergoing Breast Cancer Surgery :A Comparative Study

Conditions
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Breast Cancer Patients

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I - II patients weight 50- 100 kg) Exclusion Criteria: a history of bleeding diathesis, relevant drug allergy opioid dependence, sepsis, those with psychiatric illnesses

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dexmetedomedine<br>preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine plus Dexmedetomidine (1 µg/kg) | Drug: Dexmedetomidine<br>* preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine plus Dexmedetomidine (1 µg/kg)<br>|
| Placebo Comparator: control<br>preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine | Drug: placebo<br>* preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine<br>* Other names: control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morphine consumption mg/day | by Patient-controlled analgesia (PCA) device | 48 HOURS | 
| Visual Analog Scale (VAS), scored from 0-10 | pain measurement | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| first request of analgesia | time of the first request of analgesia postoperative if the VAS ≥ 3 | 48 hours | 
| level of stress hormones | cortisol level | 48 hours | 
| Adverse Events | Nausea Vomiting Bradycardia Hypotension Arrhythmia Pneumothorax Vascular injury Nausea Vomiting Bradycardia Hypotension Arrhythmia Pneumothorax Vascular injury Nausea,Vomiting,Arrhythmia.Hypotension,Pneumothorax,Vascular injury andItching | 48 hours |