Clinical trial NCT04498351: Magnesium Sulfate in Combination With Dexmedetomidine As Adjuvants to Levobupivacaine
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Spermatic Cord Block
Keywords: Spermatic Cord Block
Magnesium Sulfate
Dexmedetomidine
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 130
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time from injection of LA to the first postoperative analgesic request
timeFrame: UP TO 1 HOURE
Secondary outcomes:
measure: heart rate
timeFrame: up to 24 hours
measure: VAS
timeFrame: up to 24 hours
measure: perform SCAB
timeFrame: UP TO 1 HOURE
measure: total nalbuphine consumption
timeFrame: up to 24 hours
measure: Incidence of complications
timeFrame: up to 24 hours
measure: mean arterial blood pressure
timeFrame: up to 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine, Cairo University.
Study officials:
affiliation: lecture
name: mohamad abdulfatah, MD
role: PRINCIPAL_INVESTIGATOR
References: