Magnesium Sulfate in Combination With Dexmedetomidine As Adjuvants to Levobupivacaine

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

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.

Study Overview

• Status: Completed
• Conditions: Spermatic Cord Block
• Intervention / Treatment: Drug: Control Test; Drug: Dexmedetomidine; Drug: magnesium sulphate; Drug: Dexmedetomidine and magnesium sulphate

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11451
    • Faculty of Medicine, Cairo University.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: cotrol group	Drug: Control Test; 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.
Active Comparator: dexmedetomidine group	Drug: Dexmedetomidine; 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.
Active Comparator: magnesium sulphate group	Drug: magnesium sulphate; Spermatic cord block by total of 18ml levobupivacaine 0.5% plus 100 mg magnesium sulphate in 2 ml in total volume of 20 ml
Active Comparator: dexmedetomidine and magnesium sulphate group	Drug: Dexmedetomidine and magnesium sulphate; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: mohamad abdulfatah, MD, lecture

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2020
• Primary Completion (Actual): September 20, 2021
• Study Completion (Actual): October 22, 2021

Study Registration Dates

• First Submitted: July 28, 2020
• First Submitted That Met QC Criteria: July 31, 2020
• First Posted (Actual): August 4, 2020

Study Record Updates

• Last Update Posted (Actual): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 19, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Dexmedetomidine; Magnesium Sulfate; Spermatic Cord Block
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Membrane Transport Modulators; Hypnotics and Sedatives; Anticonvulsants; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Dexmedetomidine; Magnesium Sulfate
• Other Study ID Numbers: N-19-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: still working

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No