A Comparison of Ketamine versus Gabapentin in post-operative pain assessment in patients undergoing spinal neoplasms resection: A prospective, randomized, double blinded Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- To compare Ketamine versus Gabapentin for-
研究概览
简要总结
The hallmark symptom of spine tumours is pain in around 90% patients. Patients
having spine neoplasms tend to undergo complex spine procedures which presents as a unique challenge as many of these patients have pre-existing chronic pain and dependence on opioid therapy. The key non-opioid analgesics which have been studied to improve a patient’s peri-operative pain care are non-steroidal anti-inflammatory drugs (NSAID), Acetaminophen, Gabapentinoids (Gabapentin and Pregabalin), Ketamine, Lidocaine, Regional and Neuraxial techniques (local anaesthetic wound infiltration, spinal or epidural catheters, Thoracolumbar interfascial plane blocks and Erector spinae block).
With this background, this study is planned to compare and evaluate the analgesic properties of sub-anaesthetic dose of Ketamine infusion with Gabapentin in patients presenting with spinal neoplasms resection.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18-65 years
- •ASA grade I/II/III
- •Patients belonging to either sex
- •Patients planned for elective surgery for spinal tumors
- •Pre-operative motor power of bilateral lower limbs 4+/5.
排除标准
- •Refusal to consent
- •Patient lost to follow-up/not willing for follow-up
- •Known allergy to study drugs
- •Patients with history of substance abuse/addiction other than smoking
- •Patients already on Tab.
- •Gabapentin
- •Patients with pre-existing significant cardiac, respiratory, hepatic, renal disease
- •Pregnancy
- •Patients planned for mechanical ventilation after surgery.
结局指标
主要结局
To compare Ketamine versus Gabapentin for-
时间窗: Post extubation- | 15th minute | 2nd hour | 6th hour | 12th hour
1. Post-operative pain assessment at regular intervals in first 24 hours after surgery using Numeric Rating Scale (NRS)
时间窗: Post extubation- | 15th minute | 2nd hour | 6th hour | 12th hour
次要结局
- To compare Ketamine and Gabapentin in terms of-(1. Intra-operative haemodynamic fluctuations)
研究者
Kanika Gupta
All India Institute of Medical Sciences, Rishikesh, Uttarakhand