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Magnesium Sulfate in Combination With Dexmedetomidine As Adjuvants to Levobupivacaine

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04498351
Enrollment
130
Registered
2020-08-04
Start date
2020-06-30
Completion date
2021-10-22
Last updated
2022-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spermatic Cord Block

Keywords

Spermatic Cord Block, Magnesium Sulfate, Dexmedetomidine

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.

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.

Interventions

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.

DRUGDexmedetomidine

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.

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.

DRUGmagnesium 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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

Prospective randomized double blinded clinical study on humans

Intervention model description

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.

Eligibility

Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Time from injection of LA to the first postoperative analgesic requestUP TO 1 HOURE(duration of the block).

Secondary

MeasureTime frameDescription
VASup to 24 hours0 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)
perform SCABUP TO 1 HOUREThe mean time needed to perform SCAB
heart rateup to 24 hoursbeat/min
Incidence of complicationsup to 24 hourscomplications
mean arterial blood pressureup to 24 hoursmmHg
total nalbuphine consumptionup to 24 hourstotal nalbuphine consumption

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026