Analgesic Potentials of Preoperative Oral Pregabalin,Intravenous Magnesium Sulphate and Their Combination in Acute Post-thoracotomy Pain.(Randomized,Double-Blind Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Total morphine consumption
研究概览
简要总结
This study evaluates the effect of giving preoperative adjuvant drug as pregabalin or magnesium sulphate or a combination of both drugs to decrease postoperative morphine consumption and pain intensity in the first 24 hours in postoperative period . quarter of patients receive single dose oral pregabalin 300mg 1 hour preoperatively ,other quarter receive single intravenous Magnesium sulphate 50mg per Kg over 200ml saline over 20 minutes preoperatively , other quarter receive combination of both drugs , the last quarter receive placebo drugs . All patients receive 0.1mg per Kg intravenous morphine sulphate intraoperatively
详细描述
Magnesium (Mg) acts on N-methyl-D-aspartate (NMDA) receptor as a non-competitive antagonist with antinociceptive effects.
Gabapentin is an alkylated analogue of gammaaminobutyric acid (GABA) developed primarily as an anticonvulsant drug. It was described as an analgesic drug for the treatment of neuropathic pain in the 1990s. Although it is named Gabapentin,it does not bind at the GABA A or GABA B receptor. It binds with high affinity for the α2δ subunit of the presynaptic voltage-gated calcium channels, which reduce calcium-dependent release of pro-nociceptive neurotransmitters in the pain pathways. Pregabalin is a structural analogue of GABA was introduced after Gabapentin. If we used these drugs in combination to opioids preoperatively as preventive analgesia may decrease postoperative opioid consumption and pain intensity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA status of1 or 2
- •Patients undergoing thoracotomy
- •Body mass index (BMI): Less than forty and more than twenty.
排除标准
- •Known sensitivity or contraindication to drugs used in the study.
- •History of psychological disorders and/or chronic pain.
- •Patients receiving medical therapies that are considered to result in tolerance to opioids.
- •Significant liver or kidney diseases that will affects the pharmacokinetics of study drugs.
研究组 & 干预措施
Pregabalin & placebo
: will receive single dose oral Pregabalin 300 mg one hour preoperative and 200 ml of normal saline over 20 min.
干预措施: Pregabalin & Placebo (Drug)
Magnesium sulphate & Placebo
will receive preoperative single dose IV Magnesium Sulphate 50mg /kg infused over 20 minutes diluted in 200 ml normal saline and a placebo capsule similar to pregabalin 300 mg.
干预措施: Magnesium sulphate & Placebo (Drug)
Pregabalin & Magnesium sulphate
: will receive single dose oral pregabalin 300mg one hour preoperative and single dose IV Magnesium Sulphate 50mg /kg infused over 20 minutes diluted in 200 ml normal saline.
干预措施: Pregabalin & Magnesium sulphate (Drug)
Placebo
will receive placebo medications at the same time and route of administration of other groups.
干预措施: Placebo (Drug)
结局指标
主要结局
Total morphine consumption
时间窗: First 24 hours in postoperative period
patients are given regular intravenous morphine through patient controlled analgesia (PCA) and morphine consumption calculated from the PCA device
次要结局
- Pain intensity using Visual Analogue Scale(First 24 hours in postoperative period)
- Heart Rate(First 24 hours in postoperative period)
- Blood Pressure(First 24 hours in postoperative period)
- Oxygen saturation(First 24 hours in postoperative period)
- Respiratory Rate(First 24 hours in postoperative period)
- Recovery Time(Immediately after ending the surgery)
- Postoperative nausea and vomiting(First 24 hours in postoperative period)
- Sedation score(First 24 hours in postoperative period)
- Side effects from the used drugs(First 24 hours in postoperative period)
研究者
Ahmed Salah Ahmed Abd Elgalil
Demonstrator in anaesthesia department, National Cancer Institute, Egypt
National Cancer Institute, Egypt