General Anesthesia Versus Spinal Anesthesia With Local Anesthetic Infiltration for Buccal Mucosal Graft in Urethroplasty: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Tanta University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Degree of pain
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts 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.
Outcomes
Primary Outcomes
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
- 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)
Investigators
Aya Allah Hamdy Elbahy
Assistant lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University