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CompletedNCT04498351Updated Apr 1, 2022

Magnesium Sulfate in Combination With Dexmedetomidine As Adjuvants to Levobupivacaine

An Early Phase 1 interventional study of Control Test and Dexmedetomidine in Spermatic Cord Block, sponsored by Cairo University. Completed at 1 site in Egypt. Open to male participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-01.

Sponsored by Cairo University · Early Phase 1, Interventional, and Diagnostic

Phase
Early Phase 1
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Spermatic Cord Block

Keywords

  • Spermatic Cord Block
  • Magnesium Sulfate
  • Dexmedetomidine
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,907 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Early Phase 1
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
130 participants (actual)

Study arms

  • Placebo comparator
    cotrol group

    Drug: Control Test

  • Active comparator
    dexmedetomidine group

    Drug: Dexmedetomidine

  • Active comparator
    magnesium sulphate group

    Drug: magnesium sulphate

  • Active comparator
    dexmedetomidine and magnesium sulphate group

    Drug: Dexmedetomidine and magnesium sulphate

Interventions

  • DrugControl 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.

  • 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.

  • DrugDexmedetomidine and magnesium sulphate

    Drug pages: Dexmedetomidine · Magnesium Sulfate

    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.

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

06

What researchers measure

Primary outcomes

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

    (duration of the block).

    Time frame: UP TO 1 HOURE

Secondary outcomes

  1. heart rate

    beat/min

    Time frame: up to 24 hours

  2. 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)

    Time frame: up to 24 hours

  3. perform SCAB

    The mean time needed to perform SCAB

    Time frame: UP TO 1 HOURE

  4. total nalbuphine consumption

    total nalbuphine consumption

    Time frame: up to 24 hours

  5. Incidence of complications

    complications

    Time frame: up to 24 hours

  6. mean arterial blood pressure

    mmHg

    Time frame: up to 24 hours

07

Study locations

1 site
  • Faculty of Medicine, Cairo University.
    Cairo, 11451, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided — still working

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2020 to primary completion in Sep 2021, 14 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 28, 2020
First posted
Aug 4, 2020
StartActual
Jun 30, 2020
Primary completionActual
Sep 20, 2021
CompletionActual
Oct 22, 2021
Last update
Apr 1, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04498351
Lead sponsor
Cairo University
Responsible party
Amr Samir Wahdan (Lecturer of Anesthesia, Pain management and Surgical ICU, Cairo University) — Principal investigator
First posted
Aug 4, 2020
Start date
Jun 30, 2020
Primary completion
Sep 20, 2021
Completion
Oct 22, 2021
Last update
Apr 1, 2022

Study contacts

mohamad abdulfatah, MD
principal investigator · lecture

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Dexmedetomidine · Magnesium Sulfate

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