Preoperative Ketorolac for Intraoperative and Postoperative Pain Management in Scleral Buckling Surgery Under Retrobulbar Block Anesthesia: A Prospective, Randomized, Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Pain score using numerical rating scale (NRS)
研究概览
简要总结
The scleral buckle surgery is an effective way in treating retinal detachment (RD) patients. Retrobulbar block has been proved effective in scleral buckle surgery. Though retrobulbar anesthesia saves operative time and money compared to general analgesia, the intraoperative pain is frequent and a proportion of postoperative pain is often ignored. Ketorolac has been demonstrated to be a preemptive analgesia in other diseases such as adenotonsillectomy, posterior lumbar spinal fusion, laser-assisted subepithelial keratectomy (LASEK), and so forth. The aim of the investigators study is to determine the safety and preemptive analgesic effect of ketorolac in the perioperative pain control of patients undergoing RD surgery under retrobulbar anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •consent of the patient or legal guardian
- •18 years or above
- •normal height and weight
- •ASA class I, II
- •elective surgery
- •surgery time within 60min
- •understanding of the verbal numerical rating score (0-10)
排除标准
- •history of ocular surgery, trauma or infection
- •intraoperative complications
- •glaucoma or ocular hypertension (> 20 mmHg)
- •diabetic retinopathy
- •diagnosis of asthma or coagulopathy
- •chronic pain syndromes
- •history of peptic ulceration, liver or hematologic disease
- •history of chronic use of analgesics, sedatives, opioids or steroids
- •history of drug or alcohol abuse
- •history of systemic disease
- •sexually transmitted disease (STD)
- •Pregnancy, lactation;
- •cognitive impairment or psychiatric illness;
研究组 & 干预措施
Ketorolac Tromethamine
On operation day, the patients were randomly assigned to receive intramuscular Ketorolac 60-mg 30 minutes before scleral buckle surgery.
干预措施: Ketorolac Tromethamine (Drug)
Ketorolac Tromethamine
On operation day, the patients were randomly assigned to receive intramuscular Ketorolac 60-mg 30 minutes before scleral buckle surgery.
干预措施: scleral buckle (Procedure)
placebo
On operation day, the patients were randomly assigned to receive placebo before scleral buckle surgery.
干预措施: placebo (Drug)
placebo
On operation day, the patients were randomly assigned to receive placebo before scleral buckle surgery.
干预措施: scleral buckle (Procedure)
结局指标
主要结局
Pain score using numerical rating scale (NRS)
时间窗: at 24 hours postoperatively
次要结局
未报告次要终点
研究者
Lin Lu
Director, Fundus Disease Center of Zhongshan Ophthalmic Center
Sun Yat-sen University