A comparative study of epidural Ropivacaine with Dexmedetomedine and Ropivacaine with Clonidine for post operative analgesia in spine surgeries.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pain Score (VAS)
研究概览
简要总结
Background –
Managing pain following spinal surgery is still a clinical challenge. For patients to remain comfortable and heal properly, post-operative pain management must be effective. Research has been done on epidural analgesia as a possible treatment option for post-operative pain following spine procedures. Given the ability to enhance hemodynamic stability and pain reduction, α2 adrenergic agonists are proposed as adjuvants to local anaesthetics in this regard.
Objectives –
The objective of this protocol is to contrast and assess the efficiency of two different α2 adrenergic agonists, dexmedetomidine and clonidine, given in conjunction with epidural ropivacaine as adjuvants for post-operative analgesia following spine procedures. The primary objective is to evaluate the effectiveness of these analgesics in relieving pain; other goals include comparing the amount of opioids used, monitoring hemodynamic parameters, and adverse effects, and improving patient satisfaction.
Methods –
The research will be done as a prospective, double-blinded, randomised clinical trial. Random assignment will be used to allocate patients to one of two groups: either the Ropivacaine with Clonidine or the Ropivacaine with Dexmedetomidine group. A number of variables will be observed and compared between the two groups, including patient satisfaction, hemodynamic measurements, opioid use, pain scores, and side effects.
Conclusion –
The necessity of efficient post-operative pain control in spinal operations makes this study significant. This study intends to provide important insights into enhancing patient comfort and safety by contrasting the use of clonidine and dexmedetomidine with epidural ropivacaine. The findings of this study may influence clinical practice and result in more individualised pain management plans for individuals undergoing spine surgery while limiting the negative effects of opioids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator 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
- •1.Individuals between the ages of 18 and 60 years.
- •2.patients scheduled for elective spine surgery like laminectomies, discectomies, spinal fusions, and other spinal operations.
- •3.Patients with physical status classes I through II according to the American Society of Anesthesiologists (ASA).
- •4.Patients who are capable of giving their informed consent to take part in the trial.
排除标准
- •1.Patients in whom epidural anaesthesia is contraindicated.
- •2.Patients having established allergies to any of the research medications .
- •3.Patients who have had opioid dependency or persistent pain in the past.
- •4.Pregnant or lactating females.
- •5.Patients with spinal cord injuries or neurological deficiencies.
- •5.Patients with a background of severe renal, hepatic, or cardiovascular illness.
- •6.Patients who are unable to assist with data collection or pain assessment (for example, because of cognitive disability).
结局指标
主要结局
Pain Score (VAS)
时间窗: Pain Score (VAS) | Duration of Analgesia | Vital Parameters | Adverse effects if any for period of 48 hours .
Duration of Analgesia
时间窗: Pain Score (VAS) | Duration of Analgesia | Vital Parameters | Adverse effects if any for period of 48 hours .
Vital Parameters
时间窗: Pain Score (VAS) | Duration of Analgesia | Vital Parameters | Adverse effects if any for period of 48 hours .
Adverse effects if any
时间窗: Pain Score (VAS) | Duration of Analgesia | Vital Parameters | Adverse effects if any for period of 48 hours .
次要结局
未报告次要终点
研究者
Dr Aishwarya Sanjay Borode
Datta Meghe Institute of Higher Education and Research