An interventional study of Spinal anesthesia and General anesthesia in General Anesthesia, Spinal Anesthesia and Local Anesthetic Infiltration, sponsored by Tanta University. Recruiting at 1 site in Egypt. Open to male participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-07-22.
Sponsored by Tanta University · Not applicable, Interventional, and Treatment
This study aims to compare general anesthesia and spinal anesthesia with local anesthetic infiltration for buccal mucosal graft (BMG) in urethroplasty.
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.
Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Spinal anesthesia with local anesthetic infiltration.
Other: Spinal anesthesia
General anesthesia.
Other: General anesthesia
Patients will receive spinal anesthesia with local anesthetic infiltration.
Patients will receive general anesthesia.
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.
Time frame: 24 hours postoperatively
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.
Time frame: 24 hours postoperatively
Operative time
Operative time will be recorded from the induction of anesthesia to discharge to the post-anesthesia care unit (PACU).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 24 hours postoperatively
Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting information: Study protocol
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