Effect of Perioperative Oral Pregabalin in Total Knee Replacement for Postoperative Pain
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale Score (0-10)
研究概览
简要总结
This interventional randomized control trial aim to determine efficacy and safety of Oral pregabalin in improving after surgery pain control in patients undergoing total knee replacement surgeries under regional anesthesia. We'll compare the efficacy of pregabalin between two groups, pregabalin group and control group on the basis of their opioid consumption after knee operation.
详细描述
After obtaining approval from the institutional ethical committee and informed written consent, 120 patients fulfilling the inclusion criteria will be included in this study. The patients will be randomly assigned into two equal groups; Group P: Pregabalin group and Group C: control group. Group P will receive oral capsule pregabalin 75mg one hour preoperatively and Group C will not receive any premedication preoperatively.
Intraoperatively both groups will receive inj. Midazolam 2 mg before subarachnoid block with hyperbaric Bupivacaine 0.5% 2.5-3ml and fentanyl 15mcg in the operation theatre (OT). Both groups will also receive parecoxib 40mg IV and paracetamol 1G Intravenous (IV) as part of multimodal analgesia. Both groups will receive dexamethasone 8mg IV prophylactically.
Postoperatively both groups will receive Ultrasound guided Adductor canal saphenous Nerve block in the PACU with 0.2% Bupivacaine 20-30ml & dexmeditomidine1.0mcg/kg. Group P will receive oral capsule pregabalin 75 mg Q12hourly from the 1st dose for next 60 hours. Group C will not receive any medication. Both groups will receive paracetamol 1G IV Q6Hourly and Rescue Analgesia will be provided with oral oxycodone 5mg TDS and Morphine PCA, in escalating manner as per patient requirement.
for 24 hrs. After 24 hours Both groups with receive tab paracetamol1 g Q4hourly, ibuprofen 400 Q8hourly along with Tab oxycodone as PRN Q8Hourly and PCA morphine.
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 to 85 year
- •Elective Regional anesthesia.
- •Able to follow study protocol
排除标准
- •Age <18 & > 85 years
- •Patients on pregabalin for chronic neuropathic pain.
- •Patient under General anesthesia
- •Patients with chronic liver failure
- •Patients with chronic renal failure on Hemodialysis
- •Patients on opioid (>3 month)
- •Patient with complicated knee surgery
研究组 & 干预措施
Pregabalin group
this group of patient will receive cap pregabalin 75mg as premedication and will continue as twice daily dose for 72 hrs.
干预措施: Pregabalin 75mg (Drug)
Pregabalin group
this group of patient will receive cap pregabalin 75mg as premedication and will continue as twice daily dose for 72 hrs.
干预措施: adductor canal block (Procedure)
Control group
This group of patient will not receive cap pregabalin but it will receive standard medical care as routine
干预措施: adductor canal block (Procedure)
结局指标
主要结局
Visual Analogue Scale Score (0-10)
时间窗: 72 hours
visual analogue scale score at 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 60 hours and 72 hours. minimum score mean good outcome
次要结局
- Richmond Agitation Sedation Scale score {(+4) -0- (-5)}(72 hours)
- Visual Analogue Sedation score at 1st Continuous Passive Movement(with in 24 hours)
- Time of 1st analgesia request(within 24 hours)
- Incident of Hypotension(within 24 hours)
- Total opioid consumption(within 72 hours)
- Patient satisfaction(within 72 hours)
- Incident of bradycardia(within 24hours)
研究者
Mehtash butt
Chief resident
Bahrain Defence Force Hospital