Ultrasound-Guided Versus Brainlab Navigation Sphenopalatine Ganglion Block in Functional Endoscopic Sinus Surgery: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Surgical field condition
研究概览
简要总结
This study compares ultrasound-guided and Brainlab navigation sphenopalatine ganglion block (SPGB) in functional endoscopic sinus surgery (FESS).
详细描述
Functional endoscopic sinus surgery (FESS) is the treatment modality of choice for the inflammatory disease of paranasal sinuses.
Sphenopalatine ganglion block (SPGB) is a regional analgesic technique that can be used as an alternative approach to reduce blood loss and improve the operative field during FESS without the need for hypotensive agents.
Ultrasound (US)-guided nerve block is a well-established technique in regional anesthesia and offers the advantage of real-time visualization of neural and vascular structures.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 65 years.
- •Both sexes.
- •American Society of Anesthesiologists (ASA) physical status I-II.
- •Patients undergoing functional endoscopic sinus surgery under general anesthesia.
排除标准
- •Patients having a history of severe renal, hepatic, respiratory, cardiac disease, or a neurological condition.
- •Drug or alcohol abuse.
- •Chronic pain requires major analgesics, sedatives, or corticosteroids.
- •Pregnant and lactating women.
- •Hypersensitivity to local anesthetic agents.
研究组 & 干预措施
Ultrasound group
Patients will receive an ultrasound-guided sphenopalatine ganglion block (4 ml bupivacaine 0.25%).
干预措施: Ultrasound-guided sphenopalatine ganglion block (Other)
Brainlab group
Patients will receive a Brainlab navigation sphenopalatine ganglion block (4 ml bupivacaine 0.25%).
干预措施: Brainlab navigation sphenopalatine ganglion block (Other)
Low dose Brainlab group
Patients will receive a Brainlab navigation sphenopalatine ganglion block (2 ml bupivacaine 0.25%) (low dose).
干预措施: Low dose Brainlab navigation sphenopalatine ganglion block (Other)
结局指标
主要结局
Surgical field condition
时间窗: 135 min post-procedure
The Fromme-Boezaart scale (6-point scale) will be used to assess the endoscopic surgical field condition after GA induction, at the entrance of the endoscope, and after 15, 30, 45, 60, 75, 90, 105, 120, and 135 min. 0=No bleeding (cadaveric conditions). 1. Slight bleeding, no suctioning required. 2. Slight bleeding, occasional suctioning required. 3. Slight bleeding, frequent suctioning required; bleeding threatens the surgical field a few seconds after suction is removed. 4. Moderate bleeding, frequent suctioning required, and bleeding threatens the surgical field directly after suction is removed. 5. Severe bleeding, constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened, and surgery usually not possible.
次要结局
- Mean arterial pressure(135 min post-procedure)
- Heart rate(135 min post-procedure)
- Intraoperative fentanyl consumption(Intraoperatively)
- Intraoperative nitroglycerine consumption(Intraoperatively)
- Degree of pain(24 hours postoperatively)
- Time to extubation(One hour postoperatively)
- Recovery time(One hour postoperatively)
- Incidence of adverse events(24 hours postoperatively)
研究者
Mostafa Ismail Sharaf
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University