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Completed

NCT Number: NCT04498351

Magnesium Sulfate in Combination With Dexmedetomidine As Adjuvants to Levobupivacaine

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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Key information

Conditions

Spermatic Cord Block

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Faculty of Medicine, Cairo University.

Cairo, 11451, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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 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.

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

Primary outcomes

  1. Time from injection of LA to the first postoperative analgesic request

    Time frame: UP TO 1 HOURE

    (duration of the block).

Secondary outcomes

  1. heart rate

    Time frame: up to 24 hours

    beat/min

  2. VAS

    Time frame: 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)

  3. perform SCAB

    Time frame: UP TO 1 HOURE

    The mean time needed to perform SCAB

  4. total nalbuphine consumption

    Time frame: up to 24 hours

    total nalbuphine consumption

  5. Incidence of complications

    Time frame: up to 24 hours

    complications

  6. mean arterial blood pressure

    Time frame: up to 24 hours

    mmHg

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 4, 2020
Registry last updated
Apr 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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