Effect of pre-emptive analgesia with ibuprofen on post operative interleukin 6 levels in patients undergoing elective surgical procedure under general anaesthesia.
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
- To evaluate the effect of pre emptive analgesia with ibuprofen on post operative IL-6 levels in patients undergoing elective surgeries under general anaesthesia.
研究概览
简要总结
Pre emptive analgesia with ibuprofen is an evolving clinical concept for post operative pain management.IL6 indicates the extent of tissue damage and is a reliable indicator for post operative pain and inflammation.
Therefore the present study is being conducted to study the effect of pre emptive analgesia with ibuprofen on post operative IL6 levels.
Sample size calculation
The sample size was deduced to be 62. It was decided to enroll 80 patients of either gender within the age group of 18 to 65 according to the inclusion and exclusion crireria.
All the patients will be kept fasting for 8 hours before the surgery. Pre medications will be given as per the standard instituitiional protocol.
In the pre operative area a venous blood sample will be withdrawn to assess the pre operative IL6 levels
30 minutes prior to the surgery the patients will be administered either ibuprofen 400 mg or normal saline intravenously.
The surgery will be conducted as per the requirement.
In the post operative area pain using VAS scores nausea using CSS and heamodynamics will be assessed at 0 mins 30 mins 60 mins 6 hours 12 hours and 24 hours after the surgery.
Cummulative consumption of post operative analgesia using IV PCA pump and the time to first analgesic request will also be assessed.
Post operative sample of venous blood will be withdrawn 6 hours after the surgery for assessing the post operative IL6 levls.
All the observations will be noted in the prescribed performa and pre and post operative levels of IL6 will be correlated to study the effect of pre emptive analgesia with ibuprofen on post operative IL6 levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator 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
- •Patients undergoing elective surgery of duration less than 120 minutes under general anaesthesia.
排除标准
- •1.Refusal of patients for taking part in the study 2.Patients allergic to ibuprofen 3.Patients with thrombocytopenia 4.Patients with renal impairment 5.Patients with gastric ulcers 6.Patients with severe cardiac, renal and neurological issues.
- •7.Patients unable to comprehend the post operative pain scores 8.Patients with lateral sinus/ sigmoid sinus/ cavernous sinus thrombosis, petrous apicites, brain abscess.
结局指标
主要结局
To evaluate the effect of pre emptive analgesia with ibuprofen on post operative IL-6 levels in patients undergoing elective surgeries under general anaesthesia.
时间窗: baseline and at 6 hours after the surgery
次要结局
- 1.To determine IL6 levels in the preoperative and post operative period and draw correlation between them(2.To calculate the time to first analgesic request and total cumulative dose of post operative analgesic over 24 hours)
研究者
Dr Simran Raina
Government medical college and hospital, Sector 32, Chandigarh