Magnesium Sulfate in Combination With Dexmedetomidine As Adjuvants to Levobupivacaine

Spermatic Cord Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04498351
• Other study ID #: N-19-2020
• Status: Completed
• Phase: Early Phase 1
• Start date: June 30, 2020
• Est. completion date: October 22, 2021

Study information

• Verified date: March 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: October 22, 2021
• Est. primary completion date: September 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Spermatic Cord Block

Intervention

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.
• 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.
• 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.
• 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

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Cairo University.	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from injection of LA to the first postoperative analgesic request	(duration of the block).	UP TO 1 HOURE
Secondary	heart rate	beat/min	up to 24 hours
Secondary	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
Secondary	perform SCAB	The mean time needed to perform SCAB	UP TO 1 HOURE
Secondary	total nalbuphine consumption	total nalbuphine consumption	up to 24 hours
Secondary	Incidence of complications	complications	up to 24 hours
Secondary	mean arterial blood pressure	mmHg	up to 24 hours