To Compare The Opioid Sparing Effects Of Combination Of Dexamethasone And Dexmedetomidine Vs Dexamethasone In Patients Undergoing Lumbar Spine Surgery: A Prospective Double Blind Randomised Placebo Controlled Trial.
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Total intravenous Patient Controlled Analgesia (PCA) fentanyl consumption 24 hours postoperative
研究概览
简要总结
Adults commonly undergo lumbar spine surgery for conditions such as fractures, herniations, tumors, spinal stenosis, degenerative disc disease, and spondylolisthesis. Surgical spine procedures can be one of the most painful operative treatments that a patient undergoes due to the extensive tissue manipulation, muscle retraction, and the substantial number of implants required for adequate fixation. These procedures necessitate significant analgesia for adequate control of pain. Traditionally postoperative pain is treated with opioids but they are associated with range of adverse effects. Recently efforts have been promoted to reduce opioid consumption and their associated adverse effects like nausea, vomiting, urinary retention, constipation, respiratory depression.
Opioid alternatives include acetaminophen, NSAIDs, COX-2 specific inhibitors, gabapentin, local anaesthetics, dexamethasone, alpha 2 agonists and ketamine.
In our study we are using combination of above 2 drugs for opioid sparing effect. They are dexamethasone and Dexmedetomidine.
Dexamethasone (Dexa) is a glucocorticoid with a well-established analgesic and anti- emetic properties and suppresses the tissue levels of bradykinin. Inhibition of phospholipase which plays an essential role in the inflammatory chain reaction of both cyclooygenase and lipooxygenase pathway majorly contribute towards analgesic effect of dexamethasone.
Dexmedetomidine (Dex) make up the alpha-2 adrenergic receptor agonists which have been widely used as a target for medical conditions such as pain disorders, hypertension, ADHD (attention deficit hyperactivity disorder), and illicit drug use withdrawal symptoms. In recent years, alpha-2 agonists have been used as adjuncts for sedation and anesthetic use while partially blocking withdrawal symptoms in chronic opioid user. Dexmedetomidine activates α2-AR in the spinal cord reducing transmission of nociceptive signals like substance P. It has significant opioid sparing effect and is useful in intractable neuropathic pain. This advantage has made these drugs emerge as a new and effective analgesic for surgical spine patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of ASA physical status I and II posted for elective lumbar spine surgery of 1 or 2 levels.
排除标准
- •Patients refusal
- •Patients belonging to class: ASA physical status III and IV
- •Limitations in understanding use of PCA pump
- •Patients with a preoperative heart rate less than 60 beats per minute
- •Chronic analgesic or steroid use
- •Presence of significant dysfunction like cardiovascular, neurological, respiratory, hepatic or renal
- •History of uncontrolled diabetes mellitus
- •Patients having history of drug abuse
- •Known allergy to drugs.
结局指标
主要结局
Total intravenous Patient Controlled Analgesia (PCA) fentanyl consumption 24 hours postoperative
时间窗: Total intravenous Patient Controlled Analgesia (PCA) fentanyl consumption 24 hours postoperative
次要结局
- Time for first analgesic requirement(24 hours postoperative)
- Pain scores at rest and during movement at 0 min, 1 hour, 4 hours, 8 hours, 12 hours, 24 hours postoperative(0 minute, 1,4,8,12,24 hours postoperative)
- Postoperative nausea and vomiting(0, 15, 30 minutes, 1,2,4,8,12,24 hours postoperative)
- Hyperglycaemic state of patient till 24 hours after surgery(1 hour before surgery, 1 hour after surgery, 8th hourly till 24 hours postoperative)
- Wound healing/infection at 1 week(7 days postoperative)
研究者
Parin Lalwani
All India Institute of Medical Sciences