Actively Recruiting
General Anesthesia Versus Spinal Anesthesia With Local Anesthetic Infiltration for Buccal Mucosal Graft in Urethroplasty: A Randomized Controlled Trial
Led by Tanta University · Updated on 2025-07-22
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two anesthesia methods — general anesthesia and spinal anesthesia with local anesthetic infiltration — used during buccal mucosal graft (BMG) urethroplasty surgery. Urethroplasty is the standard surgical treatment for bulbar urethral strictures, a condition affecting about 300 per 100,000 males. The study aims to compare these anesthesia approaches, focusing on pain and recovery after surgery. Participants will be randomly assigned to receive either spinal anesthesia combined with local anesthetic infiltration or general anesthesia during their urethroplasty procedure. General anesthesia induces complete unconsciousness and muscle relaxation, useful for complex surgeries, while spinal anesthesia numbs the lower body, offering a faster, simpler, and often safer alternative. The study evaluates outcomes up to one week post-surgery. During the study, researchers will assess pain levels 24 hours after surgery as the primary outcome. Secondary outcomes include morphine use within 24 hours, operative time until discharge to post-anesthesia care, hospital stay length up to one week, patient satisfaction at 24 hours, and any complications within 24 hours after the procedure. Participants will be monitored closely throughout their hospital stay to gather these data.
CONDITIONS
Brief Title
General Anesthesia Versus Spinal Anesthesia With Local Anesthetic Infiltration for Buccal Mucosal Graft in Urethroplasty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patient age 6 21 years
- American Society of Anesthesiologists (ASA) classification I-II
- Patient scheduled for urethroplasty
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 hours
Participants undergo urethroplasty surgery using either spinal anesthesia with local anesthetic infiltration or general anesthesia, followed by immediate post-operative care.
1 surgical visit and post-anesthesia care unit stay
Duration - 24 hours postoperatively
Participants are monitored for pain, morphine consumption, complications, and satisfaction after surgery.
1 follow-up visit within 24 hours after surgery
Duration - Up to one week
Participants are observed for length of hospital stay and any complications until discharge from the hospital.
Visits as needed until discharge
Trial Site Locations
Total: 1 location
1
Tanta University
Tanta, El-Gharbia, Egypt, 31527
Actively Recruiting
Research Team
A
Aya Allah H Elbahy, Master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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