Magnesium Sulfate in Combination With Dexmedetomidine As Adjuvants to Levobupivacaine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-30

Study Completion Date

2021-10-22

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.

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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.

Conditions

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Spermatic Cord Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Prospective randomized double blinded clinical study on humans

Study Groups

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cotrol group

Group Type PLACEBO_COMPARATOR

Control Test

Intervention Type 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.

dexmedetomidine group

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type 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.

magnesium sulphate group

Group Type ACTIVE_COMPARATOR

magnesium sulphate

Intervention Type 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

dexmedetomidine and magnesium sulphate group

Group Type ACTIVE_COMPARATOR

Dexmedetomidine and magnesium sulphate

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes