Sphenopalatine Ganglion Block with Bupivacaine and Its Effect on Pain After Functional Endoscopic Sinus Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Mean Visual Analogue Scale (VAS) pain score over the first 24 hours postoperatively.
研究概览
简要总结
Functional endoscopic sinus surgery (FESS) is a minimally invasive procedure that is used in many inflammatory and infectious sinus diseases. Acute postoperative pain can lead to adverse consequences and good postoperative treatment of pain is essential. There is no agreement on a single protocol to treat pain after endoscopic sinus surgeries, and the usually used analgesics have some side effects that hinder their use. Current evidence is insufficient for routine clinical use of the sphenopalatine ganglion block for Functional endoscopic sinus surgery and the efficacy of sphenopalatine ganglion block for pain control after functional endoscopic sinus surgery remains controversial. This study aims to explore the influence of sphenopalatine ganglion block on pain intensity after functional endoscopic sinus surgery by comparing two groups, a group receiving the block with Bupivacaine injection, versus saline injection in the other group.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 years - 80 years.
- •ASA I and ASA II patients.
- •Consented to participate in the research.
排除标准
- •Pregnant and breastfeeding females.
- •History of allergy to bupivacaine or other local anaesthetics.
- •Patients with uncontrolled hypertension, poorly controlled cardiovascular diseases, or cerebrovascular diseases.
- •Patients with pre-existing neurological conditions.
- •Patients with history of alcohol or drug abuse.
- •Patients on anticoagulation.
- •Occurrence of surgical or anaesthetic complications or change in the anaesthesia protocol.
- •Patients showing sensitivity to Bupivacaine.
- •Patients unable to understand VAS score.
- •Patients refusing to continue participating in the study.
研究组 & 干预措施
Group A (control group) (n= 35 )
1.5 ml of normal saline was injected in the greater palatine foramen
干预措施: Sphenopalatine Ganglion Block trans oral approach saline injection (Procedure)
Group B (Bupivacaine group) (n= 35)
1.5 ml of Bupivacaine was injected in the greater palatine foramen.
干预措施: Sphenopalatine ganglion block trans oral approach bupivacaine injection (Procedure)
结局指标
主要结局
Mean Visual Analogue Scale (VAS) pain score over the first 24 hours postoperatively.
时间窗: in the PACU, at 2, 6, 12, and 24 hours after surgery
Postoperative pain will be assessed with a 10-cm scale visual analogue scale (VAS) (0 = no pain, 10 = worst imaginable pain)
次要结局
- Total requirements of rescue analgesia(24 hours postoperatively)
- Time to first rescue analgesia(24 hours postoperatively)
- Number of patients receiving rescue analgesia(24 hours postoperatively)
- Incidence and severity of adverse effects and complications(24 hours postoperatively)