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

Tanta University

Status: Enrolling

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

Treatments: Other: General anesthesia; Other: Spinal anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT07074730

36265MD360/1/25

Details and patient eligibility

About

This study aims to compare general anesthesia and spinal anesthesia with local anesthetic infiltration for buccal mucosal graft (BMG) in urethroplasty.

Full 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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Group S

Experimental group

Description:

Spinal anesthesia with local anesthetic infiltration.

Treatment:

Other: Spinal anesthesia

Group G

Active Comparator group

Description:

General anesthesia.

Treatment:

Other: General anesthesia