Spermatic Cord BlockNCT04492319
Addition of Neostigmine to Levobupivacaine
A study testing Neostigmine 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 20 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Spermatic Cord Block
- What is being tested?
- Neostigmine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Sep 2020to 20 Dec 2023
- Phase
- Interventional
- 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 20 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged from 20 to 45 years.
- American Society of Anesthesiologists I-II.
- Undergoing Testicular Sperm Extraction Surgery.
- BMI from 18.5 to 40 kg/m2
Who cannot join
- Patient refusal
- Contraindications to regional anesthesia (bleeding disorders e.g. international normalized ratio >1.5, Prothrombin Concentration <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.:
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Addition of Neostigmine to Levobupivacaine in Male Patients Receiving Ultrasound Guided Spermatic Cord Block for Postoperative Analgesia in 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 neostigmine.
- Conditions
- Spermatic Cord Block
- Being tested
- Control Test, Neostigmine
- Keywords
- Spermatic Cord Block, Neostigmine, Levobupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control TestDrug
spermatic cord block by 19 ml Levobupivacaine 0.5% plus 1 ml 0.9 normal saline in each side
NeostigmineDrug
spermatic cord block by 19 ml Levobupivacaine 0.5% plus 1 ml neostigmine 500 μg in each side .
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Not described Receives: Drug: Control Test |
| neostigmine group | Active comparator | Not described Receives: Drug: Neostigmine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from end of surgery to the first postoperative analgesic request
(duration of the block).
Measured: UP TO 24 HOURE
Secondary outcomes (4)
visual analog scale
visual analog scale ; 0 is bad / 10: is good
Measured: UP TO 24 HOURE
spermatic cord block time
The mean time needed to perform spermatic cord block
Measured: UP TO 1 HOURE
Incidence of complications
complications
Measured: up to 24 hours
Postoperative analgesic use
amount of Acetaminophen used postoperative
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 posted30 Jul 2020
- Study start29 Sep 2020
- Primary completion23 Nov 2023
- Study completion20 Dec 2023
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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 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
- Amr wahdan, Principal investigator, lecture
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492319
- Sponsor's protocol ID
- N-18-2020
- Status last verified
- Jan 2024
- First submitted
- 3 Jun 2020
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: sill working
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Addition of Neostigmine to Levobupivacaine in Male Patients Receiving Ultrasound Guided Spermatic Cord Block for Postoperative Analgesia in Testicular Sperm Extraction Surgery:
- ClinicalTrials.gov ID
- NCT04492319
- Acronym / sponsor ID
- N-18-2020
- Conditions
- Spermatic Cord Block
- Keywords
- Spermatic Cord Block, Neostigmine, Levobupivacaine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 29 Sep 2020 (actual)
- Primary completion
- 23 Nov 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 30 Jul 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 neostigmine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Drug: Control Test |
| neostigmine group | Active comparator | Drug: Neostigmine |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aged from 20 to 45 years.
- American Society of Anesthesiologists I-II.
- Undergoing Testicular Sperm Extraction Surgery.
- BMI from 18.5 to 40 kg/m2
Key exclusion criteria (6 listed)
- Patient refusal
- Contraindications to regional anesthesia (bleeding disorders e.g. international normalized ratio >1.5, Prothrombin Concentration <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 by 19 ml Levobupivacaine 0.5% plus 1 ml 0.9 normal saline in each side | Drug | control group |
| Neostigminespermatic cord block by 19 ml Levobupivacaine 0.5% plus 1 ml neostigmine 500 μg in each side . | Drug | neostigmine group |
Primary outcome
Time from end of surgery to the first postoperative analgesic request
Time frame: UP TO 24 HOURE
(duration of the block).
4 secondary outcomes
visual analog scale
Time frame: UP TO 24 HOURE
spermatic cord block time
Time frame: UP TO 1 HOURE
Incidence of complications
Time frame: up to 24 hours
Postoperative analgesic use
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 9 Jan 2024.
- Individual participant dataSharing planned: Undecided. sill 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.
Amr wahdan 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 study testing Neostigmine 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 6 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 9 Jan 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 end of surgery to the first postoperative analgesic request (time frame: UP TO 24 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 9 Jan 2024.