Etoricoxib for Routine Post-operative Pain Prophylaxis in Laparoscopic Gynaecologic Surgery With Expected Need of Post-operative Opioids
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Equal opioid consumption in both groups postoperatively
研究概览
简要总结
The aim of this trial is to compare if a single dose of oral etoricoxib 120 mg will have equal post-operative analgesic efficacy as an optimal regiment of intravenous ketorolac 30 mg + 30 mg during the first 18 hours (+/- 1 hour) after gynaecologic laparoscopic surgical procedures, where the need for post-operative opioid is expected.
详细描述
Postoperative pain can contribute to reduce the patient well-being and, if it is pronounced, delay rehabilitation and increase the total cost for nursing and treatment.
As quite extensive surgical procedures presently are being undertaken on an ambulatory basis the need for adequate post-operative pain prophylaxis is stressed. Pain and nausea/vomiting are the most frequent causes of delayed discharge or unanticipated admission to hospital stay after ambulatory surgery (1). As opioids for postoperative pain relief have a lot of unwanted side-effects (e.g. nausea, vomiting, sleepiness, obstipation, disturbed physiological sleep [2]), it has been shown beneficial, both in terms of cost-effectiveness and patient satisfaction, to reduce the need of opioids in post-operative setting by other means (i.e. non-opioid) methods of pain-relief. The concept of multimodal, non-opioid pain prophylaxis and treatment is being advocated as optimal after ambulatory surgery. The most important modes of non-opioid pain prophylaxis, at present, is paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs) and local anaesthesia. The best result is achieved when these different modes are used together in a prophylactic manner; the need of rescue opioid analgesics may be reduced by 20-50% and in many cases diminish (3). It has been shown in many studies that the NSAID is an important component in routine post-operative pain prophylaxis, e.g. NSAID in combination with paracetamol provides better analgesic effect than paracetamol alone, and may be equianalgesic to a small-medium dose of opioid (2).
There are four problems with NSAIDs when used for routine pain prophylaxis in ambulatory surgery/anaesthesia: increased bleeding tendency, gastrointestinal ulceration, renal failure and anaphylactic reactions (2-4).
There are definite potential benefits with etoricoxib in ambulatory setting (5-7): Due to cox-II selectivity there is no concern of increased bleeding tendency; thus the drug can be given pre-operatively. It is a potent, oral coxib; thus cheaper and more simple than IV NSAIDs. It has a long duration of effect; thus the need of patient attention is reduced because the first dose lasts for 24 h and a single daily dose will be optimal further on.
It has a lower potential of gastrointestinal ulceration, thus may be used in some patients where conventional NSAIDs may be contraindicated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients (American Society of Anaesthesiologists [ASA] I and II) due for elective, laparoscopic gynaecologic surgery with the expected need for post-operative opioids: hysterectomy, removal of tube(s) and/or ovarium.
- •Written informed consent.
- •Weight between 50 and 120 kg.
排除标准
- •Patients who use nonsteroidal anti-inflammatory agents (NSAIDs) in the last 48 hours (h) before surgery or are allergic to NSAIDs. Patients using steroids, anti-emetic drugs, or opioids in the last 48 h before surgery.
- •Sensitivity to the study drug or its components.
- •Cardiovascular risk conditions: heart failure, unstable hypertension, coronary artery disease (i.e. angina, previous myocardial infarction, previous coronary artery bypass surgery).
- •Cerebrovascular disease.
- •Other applicable exclusion criteria.
结局指标
主要结局
Equal opioid consumption in both groups postoperatively
次要结局
- Equal visual analogue scale (VAS) and verbal rating scale (VRS) in the first 4 hours
