Magnesium Sulphate to Bupivicaine in Serratus Anterior Plane Block in Modified Radical Mastectomy

Study Overview
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Brief Summary
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Modified radical mastectomy may be associated with severe post-operative pain, leading to chronic pain syndrome which usually requires optimal perioperative pain management.

Detailed Description
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Patients will be randomly into two equal groups (40 patients each) according to the adjuvant added to the local anesthetic (bupivacaine) in the serratus anterior plane block using a computer-generated random numbers concealed in sealed opaque envelopes. Group B: The patients will receive 20 ml of 0.5% bupivacaine plus 5 ml 0.9% normal saline with total volume 25 ml. Group BM: The patients will receive 20 ml of 0.5% bupivacaine plus 150 mg magnesium sulphate in 0.9% normal saline with a total volume of 25 ml.

Official Title
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Effectiveness of Adding Magnesium Sulphate to Bupivicaine in Ultrasound Guided Serratus Anterior Plane Block in Patients Undergoing Modified Radical Mastectomy

Conditions
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Cancer Breast, Chronic Pain Syndrome

Intervention / Treatment
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* Drug: magnesium sulphate
* Drug: bupivicaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult female patients American Society Of Anesthesiologists (ASA) class I or II scheduled for elective unilateral modified radical mastectomy Exclusion Criteria patient refusal bilateral breast surgery coagulation disorders body mass index> 35 allergy to local anaesthetics or magnesium sulphate severe respiratory or cardiac disorders pre-existing neurological deficits liver or renal insufficiency

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group BM<br>The patients will receive 20 ml of 0.5% bupivacaine plus 150 mg magnesium sulphate in 0.9% normal saline with a total volume of 25 ml. | Drug: magnesium sulphate<br>* assess the pain intensity of magnesium sulphate as an adjuvant to bupivacaine in serratus anterior plane block for modified radical mastectomy<br>Drug: bupivicaine<br>* assess the pain intensity of magnesium sulphate as an adjuvant to bupivacaine in serratus anterior plane block for modified radical mastectomy<br>|
| Active Comparator: Group B<br>The patients will receive 20 ml of 0.5% bupivacaine plus 5 ml 0.9% normal saline with total volume 25 ml | Drug: bupivicaine<br>* assess the pain intensity of magnesium sulphate as an adjuvant to bupivacaine in serratus anterior plane block for modified radical mastectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of the pain intensity | Pain assessment by visual analogue scale | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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serratus anterior plane block, magnesium sulphate