A Randomized Double-Blind Clinical Trial to Compare the Effectiveness of Intranasal and Transoral Approaches of Sphenopalatine Ganglion Block for Postoperative Analgesia Following Functional Endoscopic Sinus Surgery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- compare the effectiveness of intranasal and transoral SPGB in reducing postoperative pain after functional endoscopic sinus surgery using VAS Score
研究概览
简要总结
All the patients will recieve standard General anesthesia
Participants will be randomly assigned to Group I intranasal or Group T transoral using a computer-generated block randomization
Allocation will be concealed via sequentially numbered, opaque, sealed envelopes prepared by an independent researcher
Transoral Approach - A 24G bent needle is inserted near the second molar, 1.5 to 2 ml of local anesthetic is injected and repeated on the opposite side
Intranasal Approach - Cotton pledgets soaked in 2 ml of local anesthetic are inserted along the superior border of middle terminate to reach posterior nasopharyngeal wall where SPG lies. Left for 5 to 10 min for anesthetic absorption and then repeated on the opposite side
Following a 10 min wait post block, conventional septoplasty will be performed
After extubation, patient will be assessed by a blinded observer for post operative pain using a VAS at intervals 0 min, 30 min, 1 hr, 2 hr, 4 hr and 6 hr.
If VAS score is greater than 4, rescue analgesia with IV diclofenac 75 mg will be given
Time to 1st rescue analgesia and total post operative analgesia consumption will be recorded.
Post operative complications like nausea, vomiting, headache, visual disturbances will be monitored for 24 hr post procedure
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •American Society of Anaesthesiologists Physical Status I and II.
排除标准
- •Localized infection at the site of SPG block application.
- •Hypersensitivity to local anesthetics.
- •Patients with chronic pain or long-term opioid use might confound pain assessment.
- •Coagulopathies or on-going anticoagulant or antiplatelet therapy Pregnant or breastfeeding patients Patients with altered mental status or cognitive impairments Patients with chronic liver/kidney diseases.
结局指标
主要结局
compare the effectiveness of intranasal and transoral SPGB in reducing postoperative pain after functional endoscopic sinus surgery using VAS Score
时间窗: 6 hours post surgery
次要结局
- complications associated with intranasal or transoral approaches.
研究者
Dr Yarapotini Sneha Chowdary
Kasturba Medical College; Manipal
