Magnesium Sulfate in Combination With Dexmedetomidine As Adjuvants to Levobupivacaine

NCT04498351 | Completed Early Phase 1 DMC

• 1 other identifier: N-19-2020
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Spermatic Cord Block

Keywords

Spermatic Cord Block; Magnesium Sulfate; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• Time from injection of LA to the first postoperative analgesic request

  (duration of the block).

  UP TO 1 HOURE

Secondary Outcomes (6)

• heart rate

  up to 24 hours

• VAS

  up to 24 hours

• perform SCAB

  UP TO 1 HOURE

• total nalbuphine consumption

  up to 24 hours

• Incidence of complications

  up to 24 hours

Study Arms (4)

cotrol group

PLACEBO COMPARATOR

Drug: Control Test

dexmedetomidine group

ACTIVE COMPARATOR

Drug: Dexmedetomidine

magnesium sulphate group

ACTIVE COMPARATOR

Drug: magnesium sulphate

dexmedetomidine and magnesium sulphate group

ACTIVE COMPARATOR

Drug: Dexmedetomidine and magnesium sulphate

Interventions

Control Test DRUG

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.

cotrol group

Dexmedetomidine DRUG

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 group

Dexmedetomidine and magnesium sulphate DRUG

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.

dexmedetomidine and magnesium sulphate group

magnesium sulphate DRUG

Spermatic cord block by total of 18ml levobupivacaine 0.5% plus 100 mg magnesium sulphate in 2 ml in total volume of 20 ml

magnesium sulphate group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: the operation only in male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged from 18 to 60 years.
• ASA I-II.
• Undergoing Testicular Sperm Extraction Surgery.
• BMI from 18.5 to 30 kg/m2

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine, Cairo University.

Cairo, 11451, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• mohamad abdulfatah, MD

  lecture

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Prospective randomized double blinded clinical study on humans
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, Pain management and Surgical ICU

Model Details: 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.

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: August 4, 2020
• Study Start: June 30, 2020
• Primary Completion: September 20, 2021
• Study Completion: October 22, 2021
• Last Updated: April 1, 2022

Record last verified: 2022-03

Locations

EG (1)