Magnesium Sulfate in Combination With Dexmedetomidine As Adjuvants to Levobupivacaine

Study Overview
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Brief Summary
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Using the spermatic cord block has been of great advantage, as it has been cost saving, efficient technique whether used inon its own or combination with a sedative or . Furthermore, it provides minimal cardiac risks, early case ambulation, satisfactory postoperative pain control, as well as a reduced hospital stay and cost. one of the major drawbacks of spermatic cord block is being a single injection technique, leading to a short postoperative analgesia duration. So, to overcome this flaw some adjuvants were proven to prolong the analgesia duration as Dexmetedomidine (Dex), and magnesium.

Detailed Description
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The technique of the spermatic cord block was first described in the 1960s by Earle AS.Using the spermatic cord block has been of great advantage, as it has been cost saving, efficient technique whether used inon its own or combination with a sedative or . Furthermore, it provides minimal cardiac risks, early case ambulation, satisfactory postoperative pain control, as well as a reduced hospital stay and cost. one of the major drawbacks of spermatic cord block is being a single injection technique, leading to a short postoperative analgesia duration. So, to overcome this flaw some adjuvants were proven to prolong the analgesia duration as Dexmetedomidine (Dex), and magnesium.

Official Title
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Evaluation of Magnesium Sulfate in Combination With Dexmedetomidine As Adjuvants to Levobupivacaine for Augmenting Analgesia and Anesthesia in Ultrasound Guided Spermatic Cord Block For Testicular Sperm Extraction Surgery

Conditions
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Spermatic Cord Block

Intervention / Treatment
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* Drug: Control Test
* Drug: Dexmedetomidine
* Drug: Dexmedetomidine and magnesium sulphate
* Drug: magnesium sulphate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged from 18 to 60 years. ASA I-II. Undergoing Testicular Sperm Extraction Surgery. BMI from 18.5 to 30 kg/m2 Exclusion Criteria: Patient refusal Contraindications to regional anesthesia (bleeding disorders e.g. INR>1.5, PC<70%, platelet count<100 × 109, use of any anti-coagulants, local infection, etc.). Known allergy to local anesthetics. ASA III-IV. Patients aged less than 18 or more than 60. Body mass index >35. Patients with difficulty in evaluating their level of pain.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Following skin sterilization and local anesthetic infiltration of the superficial tissues, an echogenic 22-G block needle is inserted in-plane to the ultrasound beam in a cranial-to-caudal direction the spermatic cord in short axis and directed towards the deferent duct, contralateral to the testicular artery. The needle tip was advanced to become contact with the deferent. Correct location of the needle tip was confirmed by injecting 0.5-1 ml to see the local anesthetic spreading around the deferent duct. A total of 18ml levobupivacaine 0.5% are then injected into the spermatic cord block . The procedure is repeated on the contralateral side.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: cotrol group<br> | Drug: Control Test<br>* Spermatic cord block by18ml levobupivacaine 0.5% plus 2 ml normal saline in total volume of 20 ml. The procedure is repeated on the contralateral side.<br>|
| Active Comparator: dexmedetomidine group<br> | Drug: Dexmedetomidine<br>* Spermatic cord block by total of 18ml levobupivacaine 0.5% plus 1 μg/kg dexmedetomidine in 2 ml in total volume of 20 ml The procedure is repeated on the contralateral side.<br>|
| Active Comparator: magnesium sulphate group<br> | Drug: magnesium sulphate<br>* Spermatic cord block by total of 18ml levobupivacaine 0.5% plus 100 mg magnesium sulphate in 2 ml in total volume of 20 ml<br>|
| Active Comparator: dexmedetomidine and magnesium sulphate group<br> | Drug: Dexmedetomidine and magnesium sulphate<br>* Spermatic cord block by total of 18ml levobupivacaine 0.5% plus 1 μg/kg dexmedetomidine and 100 mg magnesium sulphate in 2 ml in total volume of 20 ml . The procedure is repeated on the contralateral side.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from injection of LA to the first postoperative analgesic request | (duration of the block). | UP TO 1 HOURE | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate | beat/min | up to 24 hours | 
| VAS | 0 No Pain 1-3 Mild Pain (nagging, annoying, interfering little with ADLs) 4-6 Moderate Pain (interferes significantly with ADLs) 7-10 Severe Pain (disabling; unable to perform ADLs) | up to 24 hours | 
| perform SCAB | The mean time needed to perform SCAB | UP TO 1 HOURE | 
| total nalbuphine consumption | total nalbuphine consumption | up to 24 hours | 
| Incidence of complications | complications | up to 24 hours | 
| mean arterial blood pressure | mmHg | up to 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexmedetomidine, Spermatic Cord Block, Magnesium Sulfate