General Anesthesia Versus Spinal Anesthesia With Local Anesthetic Infiltration for Buccal Mucosal Graft in Urethroplasty

Not Applicable

Recruiting

• Conditions: General Anesthesia; Spinal Anesthesia; Local Anesthetic Infiltration; Buccal Mucosal Graft; Urethroplasty

• Registration Number: NCT07074730
• Lead Sponsor: Tanta University

Brief Summary

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 Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-10
• Study First Submitted QC: 2025-07-10
• Study Start: 2025-07-19
• Last Update Submitted: 2025-07-19
• Study First Posted: 2025-07-20
• Last Update Posted: 2025-07-22
• Primary Completion: 2027-03-01
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

• Male patient age ≥ 21 years.
• American Society of Anesthesiologists (ASA) classification I-II.
• Patient scheduled for urethroplasty.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Degree of pain	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.

Secondary Outcome Measures

Name	Time	Method
Postoperative morphine consumption	24 hours postoperatively	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.
Operative time	Till discharge to post-anesthesia care unit (Up to 2 hours)	Operative time will be recorded from the induction of anesthesia to discharge to the post-anesthesia care unit (PACU).
Length of hospital stay	Till discharge from hospital (Up to one week).	Length of hospital stay will be recorded from admission till the discharge from the hospital.
Patient satisfaction	24 hours postoperatively	• 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).
Incidence of complications	24 hours postoperatively	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.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt