Lidocaine Versus Bupivacaine for Sphenopalatine Ganglion Block in Patients Undergoing Endoscopic Septoplasty:A Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Postoperative Pain-free duration (minutes)
研究概览
简要总结
The endoscopic septoplasty technique is one of the most frequently performed operations by otolaryngologists throughout the world. It is suggested that 86% of patients who undergo an endoscopic septoplasty would experience pain, and 75% of them suffer moderate to extreme levels of pain. Appropriate management of post-operative pain is a critical component of nasal surgery as it reduces perioperative morbidity, complications, hospital stay, and costs.
The sphenopalatine ganglion (SPG) is located in the cranial section of the autonomous nervous system; it is connected with the brain stem and the central nervous system (CNS) and bears unique characteristics favorable for the treatment of many painful syndromes involving the face and head. Sphenopalatine ganglion block (SPGB), along with general anesthesia (GA), is one of the regional anesthetic techniques used to reduce the need for systemic analgesia and provides relative hypotension with controlled heart rate that may lead to a better surgical field for endoscopic surgery. In addition, SPGB appears to shorten hospital stays and reduce narcotic requirements in the recovery area. SPGB with bupivacaine delivered repetitively appears to decreased postoperative pain and more satisfaction with the surgery for patients. Also, Bupivacaine usage in nasal surgery provides better analgesia at least in the first 8 hours period and does not cause more bleeding. On the other hand, SPGB with lidocaine was found to decrease the need for additional analgesics in the postoperative period, increase patient satisfaction, decrease the length of hospital stay, and as a consequence, reduce the rate of secondary infections. However, no previous studies have demonstrated the superiority of one drug over the other when performing an intranasal SPG block.
Aim of the work: To determine the efficacy of lidocaine versus bupivacaine for sphenopalatine ganglion block in patients undergoing endoscopic septoplasty.
详细描述
Methods:
Eligible patients will be evaluated by:
Preoperative:
Explanation of visual analog scale will be done to patients (the VAS consists of a straight, vertical 10-cm line; the bottom point represented "no pain" = (0 cm) and the top "the worst pain you could ever have" = (10 cm).
Randomization:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients planned to perform endoscopic septoplasty
- •American Society of Anesthesiologists class I and II
排除标准
- •patients that will be received additional surgery with endoscopic septoplasty
- •patients under the age of 18
- •Patients have systemic or bleeding disorders
- •patients who disincline to participate in the study
结局指标
主要结局
Postoperative Pain-free duration (minutes)
时间窗: 24 hours
this time will be recorded from the time of extubation to the first postoperative analgesic request when VAS ≥ 4
次要结局
- Postoperative Visual Analog Pain Score(24 hours)
- Surgical field assessment from incision to closure(3 hours)
研究者
Huda Fahmy Mahmoud, PhD
Assistant professor of Anaesthesia and Intensive Care department
Aswan University Hospital