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NCT Number: NCT07074730

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

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

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Key information

Age range

21 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location status: Recruiting

Location contact

Ahmed A El-Daba, MD

SUB_INVESTIGATOR

Aya Allah H Elbahy, Master

CONTACT

[email protected]

00201098959739

Hesham I El-Tatawy, MD

SUB_INVESTIGATOR

Osama M Shalaby, MD

SUB_INVESTIGATOR

Rabab M Mohamed, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Spinal anesthesia

Other

Patients will receive spinal anesthesia with local anesthetic infiltration.

General anesthesia

Other

Patients will receive general anesthesia.

Primary outcomes

  1. Degree of pain

    Time frame: 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 outcomes

  1. Postoperative morphine consumption

    Time frame: 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.

  2. Operative time

    Time frame: 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).

  3. Length of hospital stay

    Time frame: Till discharge from hospital (Up to one week).

    Length of hospital stay will be recorded from admission till the discharge from the hospital.

  4. Patient satisfaction

    Time frame: 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).
  5. Incidence of complications

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aya Allah H Elbahy, Master

CONTACT

[email protected]

00201098959739

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 20, 2025
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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