Low Dose Versus Normal Dose Ketorolac for Postoperative Pain After Prostatectomy and Hysterectomy: a Double-blind Randomized Controlled Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pain at rest 8 hours after surgery: Numeric Rating Scale (NRS)
研究概览
简要总结
A monocenter, prospective, double-blind, randomized controlled non-inferiority trial will be designed to investigate if ketorolac 10 mg is as effective for pain relief as the standard dose of 30 mg in patients undergoing robot assisted radical prostatectomy (RARP) or hysterectomy by laparoscopic assisted vaginal hysterectomy (LAVH) or total laparoscopic hysterectomy (TLH). It is hypothesised that the postoperative pain score at rest at 8 hours after surgery when receiving ketolorac 10 mg is non-inferior to the pain score at rest when receiving ketolorac 30mg.
详细描述
Ketorolac, a non-steroidal anti-inflammatory drug (NSAID), is a commonly used and effective drug for moderate to severe postoperative pain. It is widely prescribed as one of the first steps in acute and postoperative pain since decades. Because of its non-opioid character, this type of drug is safe concerning the risk of addiction and respiratory depression in the postoperative setting, but other side-effects are well known.
Gastro-intestinal (GI) haemorrhage is the most feared complication. The risk of a GI-bleeding increases with age, higher doses and longer duration of therapy. Decrease in renal function seems less important than always assumed. Feldman et al proved that developing renal failure with the use of NSAIDs was rather rare (1,1%) and similar for ketorolac as for opioids. Nonetheless, the risk again increased in a linear fashion with the duration of use. Especially for the postoperative and trauma patient, the fear of platelet inhibition and subsequent bleeding has dominated restriction of its use. Other adverse effects of ketorolac, i.e. cardiovascular toxicity, asthma, allergic reaction, etc., are usually less of a concern for the physician.
In an attempt to reduce these unwanted side effects but still have the benefit of its highly effective analgesic activity, patients should be given the lowest effective dose. Several studies have already demonstrated that ketorolac analgesic efficacy at 10 mg is similar to that at higher doses due to a ceiling effect. Unfortunately, none of the published trials investigated pain scores of the alternative dose beyond 6 hours. Based on the pharmacokinetics of ketorolac, it is possible that the lower dose will loose its analgesic effect after a shorter period. To investigate whether this alternative dose of ketorolac will preserve its analgesic efficacy up to eight hours postoperative, the primary goal of this study will be the pain score after 8 hours, right before the next dose of ketorolac.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The patients participating in the study, the surgeons, the researchers assessing the different outcome parameters and the data managers will all be blinded for group allocation.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18 and 70 years
- •Patients undergoing RARP, LAVH or TLH
- •Scheduled as inpatient surgery (at least 1 night)
- •Body weight > 60 kg
排除标准
- •Refusal of the patient
- •Cognitive impairment or no understanding of the Dutch language
- •Allergy for salicylates or NSAID
- •Pregnancy
- •Active or history of peptic ulcer disease
- •History of gastro-intestinal hemorrhage or perforation
- •History of gastric bypass
- •History of renal disease with creatinine > 1 mg/dl
- •Haematological disease
- •Tromboctopenia < 150000 / µl
- •Current anticoagulant use
- •Current clopidogrel use
- •History of substance abuse or use of medication with a suppressive effect on the central nervous system
研究组 & 干预措施
Peri- and postoperative 10 mg Ketolorac
Patients undergoing LAVH, RARP or TLH will receive dosages of 10 mg ketolorac (IV).
干预措施: 10 mg IV ketorolac (Drug)
Peri- and postoperative standard-dose 30 mg Ketolorac
Patients undergoing LAVH, RARP or TLH will receive standard dosages of 30 mg ketolorac (IV).
干预措施: 30 mg IV ketorolac (Drug)
结局指标
主要结局
Pain at rest 8 hours after surgery: Numeric Rating Scale (NRS)
时间窗: At 8 hours after surgery
Pain at rest 8 hours after surgery (measured via an 11-point Numeric Rating Scale where 0 = no pain and 10 is worst pain imaginable)
次要结局
- Piritramide consumption at PACU (mg)(At PACU until 2 hours after surgery)
- Piritramide consumption first 24 hours postoperative (mg): PCIA pump(First 24 hours after surgery)
- Quality of sleep during the first postoperative night: Numeric Rating Scale(First postoperative night)
- Patient satisfaction: Numeric Rating Scale(1week postoperatively assessed with telephone-call)
- EQ-5D(Before surgery (baseline) and 1 week postoperatively assessed with telephone-call)
- Fear of the surgical procedure: Surgical fear questionnaire(Before surgery (baseline))
- Pain at rest at PACU, 2, 4, 6, 12, 16 and 24 hours after surgery: Numeric Rating Scale (NRS)(At PACU, 2, 4, 6, 12, 16 and 24 hours after surgery)
- Pain at movement at PACU, 2, 4, 6, 8, 12, 16 and 24 hours after surgery: Numeric Rating Scale(At PACU, 2, 4, 6, 8, 12, 16 and 24 hours after surgery)
- Global Surgical Recovery Index(Before surgery (baseline) and 1 week postoperatively assessed with telephone-call)
- Adverse effects of ketorolac use or suspected by the use of ketorolac(During study completion, i.e. 1 week after the surgery)
- Expected pain after surgery: Numeric Rating Scale(Before surgery (baseline))
- Pain before surgery: Numeric Rating Scale(Before surgery (baseline))
研究者
Stessel Björn
Principle Investigator
Jessa Hospital