Spermatic Cord BlockEarly Phase 1NCT04498351
Magnesium Sulfate in Combination With Dexmedetomidine As Adjuvants to Levobupivacaine
A Early Phase 1 study testing Dexmedetomidine, Dexmedetomidine and magnesium sulphate and magnesium sulphate in people with Spermatic Cord Block, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Spermatic Cord Block
- What is being tested?
- Dexmedetomidine, Dexmedetomidine and magnesium sulphate and magnesium sulphate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2020to 22 Oct 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged from 18 to 60 years.
- ASA I-II.
- Undergoing Testicular Sperm Extraction Surgery.
- BMI from 18.5 to 30 kg/m2
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Spermatic Cord Block
- Being tested
- Control Test, Dexmedetomidine, Dexmedetomidine and magnesium sulphate, magnesium sulphate
- Keywords
- Spermatic Cord Block, Magnesium Sulfate, Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control TestDrug
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.
DexmedetomidineDrug
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 sulphateDrug
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 sulphateDrug
Spermatic cord block by total of 18ml levobupivacaine 0.5% plus 100 mg magnesium sulphate in 2 ml in total volume of 20 ml
| Study group | Role | What they receive |
|---|---|---|
| cotrol group | Placebo comparator | Not described Receives: Drug: Control Test |
| dexmedetomidine group | Active comparator | Not described Receives: Drug: Dexmedetomidine |
| magnesium sulphate group | Active comparator | Not described Receives: Drug: magnesium sulphate |
| dexmedetomidine and magnesium sulphate group | Active comparator | Not described Receives: Drug: Dexmedetomidine and magnesium sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from injection of LA to the first postoperative analgesic request
(duration of the block).
Measured: UP TO 1 HOURE
Secondary outcomes (6)
heart rate
beat/min
Measured: up to 24 hours
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)
Measured: up to 24 hours
perform SCAB
The mean time needed to perform SCAB
Measured: UP TO 1 HOURE
total nalbuphine consumption
total nalbuphine consumption
Measured: up to 24 hours
Incidence of complications
complications
Measured: up to 24 hours
mean arterial blood pressure
mmHg
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start30 Jun 2020
- Primary completion20 Sep 2021
- Study completion22 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spermatic Cord BlockStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Samir Wahdan, Cairo University
- Investigators
- mohamad abdulfatah, MD, Principal investigator, lecture
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498351
- Sponsor's protocol ID
- N-19-2020
- Status last verified
- Mar 2022
- First submitted
- 28 Jul 2020
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: still working
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04498351
- Acronym / sponsor ID
- N-19-2020
- Conditions
- Spermatic Cord Block
- Keywords
- Spermatic Cord Block, Magnesium Sulfate, Dexmedetomidine
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 22 Oct 2021 (actual)
- First posted
- 4 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| cotrol group | Placebo comparator | Drug: Control Test |
| dexmedetomidine group | Active comparator | Drug: Dexmedetomidine |
| magnesium sulphate group | Active comparator | Drug: magnesium sulphate |
| dexmedetomidine and magnesium sulphate group | Active comparator | Drug: Dexmedetomidine and magnesium sulphate |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aged from 18 to 60 years.
- ASA I-II.
- Undergoing Testicular Sperm Extraction Surgery.
- BMI from 18.5 to 30 kg/m2
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control TestSpermatic 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. | Drug | cotrol group |
| DexmedetomidineSpermatic 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. | Drug | dexmedetomidine group |
| Dexmedetomidine and magnesium sulphateSpermatic 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. | Drug | dexmedetomidine and magnesium sulphate group |
| magnesium sulphateSpermatic cord block by total of 18ml levobupivacaine 0.5% plus 100 mg magnesium sulphate in 2 ml in total volume of 20 ml | Drug | magnesium sulphate group |
Primary outcome
Time from injection of LA to the first postoperative analgesic request
Time frame: UP TO 1 HOURE
(duration of the block).
6 secondary outcomes
heart rate
Time frame: up to 24 hours
VAS
Time frame: up to 24 hours
perform SCAB
Time frame: UP TO 1 HOURE
total nalbuphine consumption
Time frame: up to 24 hours
Incidence of complications
Time frame: up to 24 hours
mean arterial blood pressure
Time frame: up to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Individual participant dataSharing planned: Undecided. still working
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mohamad abdulfatah, MD principal investigator
lecture
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dexmedetomidine, Dexmedetomidine and magnesium sulphate and magnesium sulphate in people with Spermatic Cord Block, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from injection of LA to the first postoperative analgesic request (time frame: UP TO 1 HOURE). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.