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

General Anesthesia Versus Spinal Anesthesia With Local Anesthetic Infiltration for Buccal Mucosal Graft in Urethroplasty: A Randomized Controlled Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07074730
Enrollment
100
Registered
2025-07-20
Start date
2025-07-19
Completion date
2027-03-01
Last updated
2025-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERSpinal anesthesia

Patients will receive spinal anesthesia with local anesthetic infiltration.

OTHERGeneral anesthesia

Patients will receive general anesthesia.

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
21 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Degree of pain24 hours postoperativelyEach 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

MeasureTime frameDescription
Postoperative morphine consumption24 hours postoperativelyRescue 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 timeTill 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 stayTill discharge from hospital (Up to one week).Length of hospital stay will be recorded from admission till the discharge from the hospital.
Patient satisfaction24 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 complications24 hours postoperativelyIncidence 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.

Countries

Egypt

Contacts

Primary ContactAya Allah H Elbahy, Master
3ed2318@gmail.com00201098959739

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026