General AnesthesiaNCT07074730
General Anesthesia Versus Spinal Anesthesia With Local Anesthetic Infiltration for Buccal Mucosal Graft in Urethroplasty
A study testing Spinal anesthesia and General anesthesia in people with General Anesthesia and Spinal Anesthesia, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to compare general anesthesia and spinal anesthesia with local anesthetic infiltration for buccal mucosal graft (BMG) in urethroplasty. Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- General Anesthesia, Spinal Anesthesia, Local Anesthetic Infiltration
- What is being tested?
- Spinal anesthesia and General anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Jul 2025to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patient age ≥ 21 years.
- American Society of Anesthesiologists (ASA) classification I-II.
- Patient scheduled for urethroplasty.
Who cannot join
- Patients who are taking analgesics for chronic illness or have a history of substance abuse.
- Patients who are unable to describe their postoperative pain (e.g., neuropsychiatric disorder).
- Patients with known local anesthetics and opioid allergy.
- Patients with infection at the site of the needle puncture.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El-Gharbia, 31527
Aya Allah H Elbahy, Master, 00201098959739, 3ed2318@gmail.com
Osama M Shalaby, MD
About this study
Official title: General Anesthesia Versus Spinal Anesthesia With Local Anesthetic Infiltration for Buccal Mucosal Graft in Urethroplasty: A Randomized Controlled Trial
This study aims to compare general anesthesia and spinal anesthesia with local anesthetic infiltration for buccal mucosal graft (BMG) in urethroplasty.
Read the detailed description
Urethroplasty is a surgical procedure aimed at reconstructing the urethra and is considered the standard treatment for bulbar urethral strictures, with different types of tissues used as either grafts or flaps, affecting approximately 300 per 100,000 males.
Postoperative pain following urethroplasty with buccal mucosal graft (BMG) is primarily related to the oral graft harvest site.
General Anesthesia provides a state of complete unconsciousness, ensuring that patients are free from pain and awareness during the surgery. It can be beneficial in complex cases or when extended manipulation is required, allowing for muscle relaxation and controlled ventilation.
On the other hand, spinal anesthesia involves the injection of anesthesia into the cerebrospinal fluid, resulting in targeted numbness in the lower body. This technique can be advantageous for its fast, simple, cost-effective method, rapid onset, lower risk of systemic complications, and preservation of airway reflexes.
- Conditions
- General Anesthesia, Spinal Anesthesia, Local Anesthetic Infiltration, Buccal Mucosal Graft, Urethroplasty
- Being tested
- Spinal anesthesia, General anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anesthesiaOther
Patients will receive spinal anesthesia with local anesthetic infiltration.
General anesthesiaOther
Patients will receive general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Group S | Experimental | Spinal anesthesia with local anesthetic infiltration. Receives: Other: Spinal anesthesia |
| Group G | Active comparator | General anesthesia. Receives: Other: General anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of pain
Each patient will be instructed about postoperative pain assessment with the Numerical rating Scale (NRS). NRS (0 represents "no pain"; (1-3) mild pain; (4-6) moderate pain; (7-10) severe pain. NRS will be assessed at 0, 4, 8, 12, 18 and 24h postoperatively.
Measured: 24 hours postoperatively
Secondary outcomes (5)
Postoperative morphine consumption
Rescue analgesia of morphine will be given as 3 mg bolus if the Numerical rating Scale (NRS)> 3 to be repeated after 30 min if pain persists until the NRS< 4.
Measured: 24 hours postoperatively
Operative time
Operative time will be recorded from the induction of anesthesia to discharge to the post-anesthesia care unit (PACU).
Measured: Till discharge to post-anesthesia care unit (Up to 2 hours)
Length of hospital stay
Length of hospital stay will be recorded from admission till the discharge from the hospital.
Measured: Till discharge from hospital (Up to one week).
Patient satisfaction
- Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely unsatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied).
Measured: 24 hours postoperatively
Incidence of complications
Incidence of complications such as urinary retention, nausea, headache, local anesthetic systemic toxicity (LAST), bradycardia, hypotension, nausea, vomiting, respiratory depression or any other complication will be recorded.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start19 Jul 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Allah Hamdy Elbahy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074730
- Sponsor's protocol ID
- 36265MD360/1/25
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General Anesthesia Versus Spinal Anesthesia With Local Anesthetic Infiltration for Buccal Mucosal Graft in Urethroplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07074730
- Acronym / sponsor ID
- 36265MD360/1/25
- Conditions
- General Anesthesia, Spinal Anesthesia, Local Anesthetic Infiltration, Buccal Mucosal Graft, Urethroplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 19 Jul 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 20 Jul 2025 (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.
This study aims to compare general anesthesia and spinal anesthesia with local anesthetic infiltration for buccal mucosal graft (BMG) in urethroplasty.
Detailed description
Urethroplasty is a surgical procedure aimed at reconstructing the urethra and is considered the standard treatment for bulbar urethral strictures, with different types of tissues used as either grafts or flaps, affecting approximately 300 per 100,000 males.
Postoperative pain following urethroplasty with buccal mucosal graft (BMG) is primarily related to the oral graft harvest site.
General Anesthesia provides a state of complete unconsciousness, ensuring that patients are free from pain and awareness during the surgery. It can be beneficial in complex cases or when extended manipulation is required, allowing for muscle relaxation and controlled ventilation.
On the other hand, spinal anesthesia involves the injection of anesthesia into the cerebrospinal fluid, resulting in targeted numbness in the lower body. This technique can be advantageous for its fast, simple, cost-effective method, rapid onset, lower risk of systemic complications, and preservation of airway reflexes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group S | Experimental | Other: Spinal anesthesiaSpinal anesthesia with local anesthetic infiltration. |
| Group G | Active comparator | Other: General anesthesiaGeneral anesthesia. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male patient age ≥ 21 years.
- American Society of Anesthesiologists (ASA) classification I-II.
- Patient scheduled for urethroplasty.
Key exclusion criteria (4 listed)
- Patients who are taking analgesics for chronic illness or have a history of substance abuse.
- Patients who are unable to describe their postoperative pain (e.g., neuropsychiatric disorder).
- Patients with known local anesthetics and opioid allergy.
- Patients with infection at the site of the needle puncture.
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 |
|---|---|---|
| Spinal anesthesiaPatients will receive spinal anesthesia with local anesthetic infiltration. | Other | Group S |
| General anesthesiaPatients will receive general anesthesia. | Other | Group G |
Primary outcome
Degree of pain
Time frame: 24 hours postoperatively
Each patient will be instructed about postoperative pain assessment with the Numerical rating Scale (NRS). NRS (0 represents "no pain"; (1-3) mild pain; (4-6) moderate pain; (7-10) severe pain. NRS will be assessed at 0, 4, 8, 12, 18 and 24h postoperatively.
5 secondary outcomes
Postoperative morphine consumption
Time frame: 24 hours postoperatively
Operative time
Time frame: Till discharge to post-anesthesia care unit (Up to 2 hours)
Length of hospital stay
Time frame: Till discharge from hospital (Up to one week).
Patient satisfaction
Time frame: 24 hours postoperatively
Incidence of complications
Time frame: 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal anesthesia and General anesthesia in people with General Anesthesia and Spinal Anesthesia, run by Tanta 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 22 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aya Allah H Elbahy, Master (00201098959739, 3ed2318@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of pain (time frame: 24 hours postoperatively). 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 22 Jul 2025.