Analgesic Efficacy of Ultrasound Guided Erector Spinae Block for Modified Radical Mastectomy

Study Overview
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Brief Summary
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To compare the analgesic efficacy of dexmedetomidine and magnesium sulphate as adjuvants to levobupivacaine in erector spinae plane block in modified radical mastectomy surgery for acute and chronic pain management.

Detailed Description
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3 groups. Group (C) / (I):20 patient (control group) : Patients will receive 20 ml 0.25% levobupivacaine into the interfascial plane below erector spinae muscle at level of T5. Group (D)/ (II) :20 patient (Dexmetonidine group) : Patient will receive 20ml 0.25% levobupivacaineas above + 1μ/kg dexmedetomidine. Group (M) / (III) : 20 patient (magnesium slphate group) : Patient will receive 20ml 0.25% levobupivacaineas above + 0.7 mg/kg MgSo4 . The patient, the anesthesiologist who administered the drugs, and the data collector will be blinded to the study drugs.

Official Title
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Analgesic Efficacy of Magnesium Sulphate as an Adjuvant to Levo-bupivacine in Ultrasound Guided Erector Spinae Plan Block for Modified Radical Mastectomy

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Procedure: ultrasound guided erector spinae plan block using bupivacaine for modified radical mastectomy
* Procedure: ultrasound guided erector spinae plan block with bupivacaine and Dexmetonidine for modified radical mastectomy
* Procedure: ultrasound guided erector spinae plan block with bupivacaine and magnesium slphate for modified radical mastectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female patient American society of anesthesiologists (ASA) I and II physical status age from 25 to 70 years old scheduled for either left or right modified radical mastectomy (MRM). Exclusion Criteria: infection of the skin at or near site of needle puncture coagulopathy drug hypersensitivity or allergy to the studied drugs central or peripheral neuropathy significant organ dysfunction cardiac dysrrhythmias obesity (BMI>35kg/m2) recently use analgesic drugs

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group (C) (control group):<br>Patient will receive 20 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5. | Procedure: ultrasound guided erector spinae plan block using bupivacaine for modified radical mastectomy<br>* Ultrasound guided Erector spinae plane (ESP) block will be given with patient in sitting position depending on surgical site (left or right) ESP block will be given using high frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to thoracic fifth spinous process, then Trapezius muscle, Rhomboidus major muscle, and erector spinae muscle<br>|
| Active Comparator: Group (D) (Dexmetonidine group):<br>Patient will receive 20ml 0.25% levobupivacaine + 1μ/kg dexmedetomidine into interfascial plane below erector spinae muscle at level of T5.. | Procedure: ultrasound guided erector spinae plan block with bupivacaine and Dexmetonidine for modified radical mastectomy<br>* Ultrasound guided Erector spinae plane (ESP) block will be given with patient in sitting position depending on surgical site (left or right) ESP block will be given using high frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to thoracic fifth spinous process, then Trapezius muscle, Rhomboidus major muscle, and erector spinae muscle<br>|
| Active Comparator: Group (M) (magnesium slphate group):<br>Patient will receive 20ml 0.25% levobupivacaine + 0.7 mg/kg MgSo4 into interfascial plane below erector spinae muscle at level of T5.. | Procedure: ultrasound guided erector spinae plan block with bupivacaine and magnesium slphate for modified radical mastectomy<br>* Ultrasound guided Erector spinae plane (ESP) block will be given with patient in sitting position depending on surgical site (left or right) ESP block will be given using high frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to thoracic fifth spinous process, then Trapezius muscle, Rhomboidus major muscle, and erector spinae muscle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgesia requirement | first request for analgesia and total analgesia requirements | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| chronic pain assessment | Assessment of chronic pain at 1-3 and 6 month post-operatively using LANSS pain score. a score of 12 or more is suggestive of neuropathic pain. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erector Spinae Block, magnesium sulphate, dexmedetomidine