Efficacy and Safety of Dexmedetomidine Added to Modified Pectoral's Block

Study Overview
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Brief Summary
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The Pecs block (pectoral nerves block) is an easy and reliable superficial block inspired by the infraclavicular block approach and the intercostal abdominis plane blocks . Many additives were used in combination with local anesthetics in Pecs block to prolong the postoperative analgesia (fentanyl, dexmedetomidine).

Detailed Description
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60 patients 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 interfascial 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 interfascial 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 Female

Intervention / Treatment
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* Drug: Dexmedetomidine Injection [Precedex]
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I - II patients weight 50- 100 kg age 18-60 years Exclusion Criteria: History of bleeding diathesis Relevant drug allergy Opioid dependence Sepsis Those with psychiatric illnesses that would interfere with perception and assessment of pain will be excluded from the study

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group I (Bupivacaine group)<br>ultrasound guided modified Pec's block with 30 mL of 0.25% bupivacaine divided into 10 ml injected between the pectoralis muscles and 20 ml between the Pectoralis minor muscle and the serratus muscle | Drug: Bupivacaine<br> <br> |
| Active Comparator: Dexmedetomidine Injection [Precedex]<br>ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine plus Dexmedetomidine Injection [Precedex] (1 µg/kg) divided into 20 ml injected between the pectoralis muscles and 10 ml injected between the Pectoralis minor muscle and the serratus muscle. | Drug: Dexmedetomidine Injection [Precedex]<br>* ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine (markyrene R sigma -Tec, Egypt) plus (1 µg/kg) Dexmedetomidine Injection [Precedex]<br>* Other names: [Precedex];Drug: Bupivacaine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| I.V patient controlled analgesia (PCA) morphine consumption | the total dose of I.V patient controlled analgesia (PCA) morphine consumption in the first 48 hours postoperative | 48 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain relief | by visual analogue scale measurement | 48 hour |