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Recruiting NCT07074730

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

No phase Interventional General Anesthesia Spinal Anesthesia Local Anesthetic Infiltration Buccal Mucosal Graft

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Spinal anesthesia, General anesthesia.
Who it may be relevant to
Registry conditions: General Anesthesia, Spinal Anesthesia, Local Anesthetic Infiltration, Buccal Mucosal Graft. Basic parameters: from 21 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Other Spinal anesthesia
    Patients will receive spinal anesthesia with local anesthetic infiltration.
  • Other General anesthesia
    Patients will receive general anesthesia.

Primary outcome measures

  • Degree of pain [Time frame: 24 hours postoperatively]
Secondary outcome measures (5)
  • Postoperative morphine consumption [Time frame: 24 hours postoperatively]
  • Operative time [Time frame: Till discharge to post-anesthesia care unit (Up to 2 hours)]
  • Length of hospital stay [Time frame: Till discharge from hospital (Up to one week).]
  • Patient satisfaction [Time frame: 24 hours postoperatively]
  • Incidence of complications [Time frame: 24 hours postoperatively]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Tanta University — Tanta

Identifiers

NCT: NCT07074730 · 36265MD360/1/25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗