Magnesium Sulfate in Combination With Dexmedetomidine As Adjuvants to Levobupivacaine

Early Phase 1

Completed

• Conditions: Spermatic Cord Block
• Interventions: Drug: Control Test; Drug: Dexmedetomidine and magnesium sulphate; Drug: magnesium sulphate; Drug: Dexmedetomidine

• Registration Number: NCT04498351
• Lead Sponsor: Cairo University

Brief Summary

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

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 Timeline

• Study Start: 2020-06-30
• Study First Submitted: 2020-07-28
• Study First Submitted QC: 2020-07-31
• Study First Posted: 2020-08-04
• Primary Completion: 2021-09-20
• Study Completion: 2021-10-22
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-19
• Last Update Posted: 2022-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cotrol group	Control Test	-
dexmedetomidine and magnesium sulphate group	Dexmedetomidine and magnesium sulphate	-
magnesium sulphate group	magnesium sulphate	-
dexmedetomidine group	Dexmedetomidine	-

Primary Outcome Measures

Name	Time	Method
Time from injection of LA to the first postoperative analgesic request	UP TO 1 HOURE	(duration of the block).

Secondary Outcome Measures

Name	Time	Method
perform SCAB	UP TO 1 HOURE	The mean time needed to perform SCAB
Incidence of complications	up to 24 hours	complications
total nalbuphine consumption	up to 24 hours	total nalbuphine consumption
mean arterial blood pressure	up to 24 hours	mmHg
heart rate	up to 24 hours	beat/min
VAS	up to 24 hours	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)

Trial Locations

Locations (1)

Faculty of Medicine, Cairo University.; 🇪🇬 Cairo, Egypt