General Anesthesia Versus Spinal Anesthesia With Local Anesthetic Infiltration for Buccal Mucosal Graft in Urethroplasty: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Degree of pain
研究概览
简要总结
This study aims to compare general anesthesia and spinal anesthesia with local anesthetic infiltration for buccal mucosal graft (BMG) in urethroplasty.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patient age ≥ 21 years.
- •American Society of Anesthesiologists (ASA) classification I-II.
- •Patient scheduled for urethroplasty.
排除标准
- •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.
研究组 & 干预措施
Group S
Spinal anesthesia with local anesthetic infiltration.
干预措施: Spinal anesthesia (Other)
Group G
General anesthesia.
干预措施: General anesthesia (Other)
结局指标
主要结局
Degree of pain
时间窗: 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.
次要结局
- 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)
研究者
Aya Allah Hamdy Elbahy
Assistant lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University