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

NCT ID: NCT07074730

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-19
• Study Completion Date: 2027-03-01

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.

Conditions

General Anesthesia; Spinal Anesthesia; Local Anesthetic Infiltration; Buccal Mucosal Graft; Urethroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group S

Spinal anesthesia with local anesthetic infiltration.

Group Type: EXPERIMENTAL

Spinal anesthesia

Intervention Type: OTHER

Patients will receive spinal anesthesia with local anesthetic infiltration.

Group G

General anesthesia.

Group Type: ACTIVE_COMPARATOR

General anesthesia

Intervention Type: OTHER

Patients will receive general anesthesia.

Interventions

Spinal anesthesia

Patients will receive spinal anesthesia with local anesthetic infiltration.

Intervention Type: OTHER

General anesthesia

Patients will receive general anesthesia.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Aya Allah Hamdy Elbahy

Assistant lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University

Tanta, El-Gharbia, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Aya Allah H Elbahy, Master

Role: CONTACT

3ed2318@gmail.com

00201098959739

Facility Contacts

Aya Allah H Elbahy, Master

Role: primary

3ed2318@gmail.com

00201098959739

Other Identifiers

36265MD360/1/25

Identifier Type: -

Identifier Source: org_study_id