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

NCT07074730 | Recruiting

• 1 other identifier: 36265MD360/1/25
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Degree of pain

  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.

  24 hours postoperatively

Secondary Outcomes (5)

• Postoperative morphine consumption

  24 hours postoperatively

• Operative time

  Till discharge to post-anesthesia care unit (Up to 2 hours)

• Length of hospital stay

  Till discharge from hospital (Up to one week).

• Patient satisfaction

  24 hours postoperatively

• Incidence of complications

  24 hours postoperatively

Study Arms (2)

Group S

EXPERIMENTAL

Spinal anesthesia with local anesthetic infiltration.

Other: Spinal anesthesia

Group G

ACTIVE COMPARATOR

General anesthesia.

Other: General anesthesia

Interventions

Spinal anesthesia OTHER

Patients will receive spinal anesthesia with local anesthetic infiltration.

Group S

General anesthesia OTHER

Patients will receive general anesthesia.

Group G

Eligibility Criteria

• Age: 21 Years+
• Gender Eligibility Details: Males scheduled for urethroplasty
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patient age ≥ 21 years.
• American Society of Anesthesiologists (ASA) classification I-II.
• Patient scheduled for urethroplasty.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

MeSH Terms

Interventions

Anesthesia, Spinal; Anesthesia, General

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Central Study Contacts

Aya Allah H Elbahy, Master

CONTACT

00201098959739; 3ed2318@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 20, 2025
• Study Start: July 19, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)