The Effect of NSAID Steroid Therapy for PGE2 Level and Analgesia After Percutaneous Nephrolithotomy Surgery, a Double Blinded Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- NRS Score
研究概览
简要总结
The goal of this clinical trial is to learn if combination of NSAID-steroid can decrease the PGE2 level and postoperative pain after percutaneous nephrolithotomy surgery. It will also learn about the side effects of combination of those drugs. The main questions it aims to answer are:
Does combination of NSAID steroid can lower the PGE2 level and NRS score after percutaneous nephrolithotomy surgery? What side effect do participants have when taking combination of NSAID-steroid after percutaneous nephrolithotomy surgery? Researchers will compare Group IBU-PCT-DEX (ibuprofen -paracetamol-dexamethasone), Group IBU-PCT-placebo (ibuprofen-paracetamol-placebo), and Group PCT-placebo-placebo (paracetamol-placebo-placebo) to see the difference level of PGE2 and NRS score after percutaneous nephrolithotomy surgery.
Participants will:
Receive drug intravenously according to group allocation, every 8 hours Report the side effects when taking medication during trial
详细描述
Our study aim to investigate the effect of NSAID steroid therapy to PGE2 level and analgesia after percutaneous nephrolithotomy surgery. This study is a double blind randomized controlled trial at a primary health care center in Purwokerto, Indonesia. This trial involved 45 patient who underwent elective percutaneous nephrolithotomy surgery who met the inclusion and exclusion criteria. Patient was randomized and divided into three groups. Each group consisted of 15 patients. Ibuprofen 2x400 mg iv + paracetamol 2x1 gr iv + dexamethasone 2x5 mg iv will be given within the IBU-PCT-DEX intervention. Ibuprofen 2x400 mg iv + paracetamol 2x1gr iv + 2xplacebo (normal saline alike dexamethasone) iv will be given within the IBU-PCT-placebo intervention. Paracetamol 2x1 gr iv + 2xplacebo (normal saline alike ibuprofen) + 2xplacebo (normal saline alike dexamethasone) will be given within the PCT-placebo-placebo intervention. The analgesics were given during surgery and 8 hours after first drug administration. Plasma level of PGE2 will be measured with ELISA. and analgesia will be measured using numeric rating scale (NRS) an hour after two times drug administration. Primary outcome was PGE2 level and NRS score after percutaneous nephrolithotomy among three group of comparison. Secondary outcome was the side effect of analgesic.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective, percutaneous nephrolithotomy surgery
- •Age ≥ 18 years to ≤ 70 years
- •Body mass index (BMI) > 18 kg/m2 to < 40 kg/m2
- •American Society of Anesthesiologists (ASA) Physical Status Classification System 1-
- •Written informed consent to participate in the trial.
排除标准
- •Patients with allergy to ibuprofen, paracetamol, and dexamethasone
- •Patients with uncontrolled diabetes mellitus
- •Patients with previous history of alcohol or drug abuse
- •Patients who unconscious
- •Patients with neurological disorders
- •Patients with cognitive impairment
- •Patients who incapable of communication
- •Patients with daily use of systemic glucocorticoids within 3 months prior to surgery
- •Patients with daily use of high-dose opioid (tramadol 150 mg/day or morphine >30 mg/day orally) or use transdermal opioid
- •Patients who are contraindicated to ibuprofen or paracetamol, include a history of peptic ulcers, renal failure (glomerular filtration rate <60 ml/kg/1.73 m2), heart failure, severe liver dysfunction, thrombocytopenia <100,000/L.
研究组 & 干预措施
PCT-placebo-placebo
Paracetamol (Bernofarm) 1 gr iv; placebo (normal saline alike paracetamol); placebo (normal saline alike dexamethasone) will be given two times administration, interval 8 hour, within the PCT-placebo intervention.
干预措施: PCT-placebo-placebo (Drug)
IBU-PCT-placebo
Ibuprofen (Peinlos) 400 mg iv; Paracetamol (Bernofarm) 1 gr iv; and placebo (normal saline alike dexamethasone) will be given two times administration, interval 8 hour, within the IBU-PCT-placebo intervention.
干预措施: IBU-PCT-placebo (Drug)
IBU-PCT-DEX
Ibuprofen (Peinlos) 400 mg iv, Paracetamol (Bernofarm) 1 gr iv, dexamethasone (Phapros) 5 mg iv will be given two times administration, interval 8 hour, within IBU-PCT-DEX intervention.
干预措施: IBU-PCT-DEX (Drug)
结局指标
主要结局
NRS Score
时间窗: from enrollment to the end of treatment at 5 weeks
NRS score will be measured an hour after two times drug administration. The value scale from 0 to 10. Higher scores mean outcome worse.
PGE2 level
时间窗: from enrollment to the end of treatment at 5 weeks
PGE2 level will be measured by ELISA elabscience kit. PGE2 level will be measured an hour after two times drug administration, using plasma sample. The result is displayed in pg/ml (numeric scale)
次要结局
- The side effects(from enrollment to the end of treatment at 5 weeks)
研究者
Erni Noviani
Principal Investigator Department Anesthesiology and Intensive Therapy
Universitas Jenderal Soedirman