Comparison of analgesic efficacy of pre-emptive paracetamol, ibuprofen and paracetamol-ibuprofen in orthopedic surgeries.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Pain will be assessed with Visual Analogue Scale between 0 and 10
研究概览
简要总结
The 109 patients will be randomly divided into three groups:
1. Group B (n=36) will receive 400 mg of Ibuprofen intra-venously 15 minutes before induction
2. Group D (n=36) will receive 1 gm of Paracetamol intra-venously 15 minutes before induction.
3. Group P (n=36) will receive 400 mg of Ibuprofen intra-venously and 1 gm of Paracetamol intra-venously 15 minutes before induction.
Procedure on the day of surgery:
15 minutes before induction , the patients in group B will receive 400 mg of inj ibuprofen intravenously, the patients in group D will receive 1 gm of inj paracetamol intravenously, the patients in group P will receive 400 mg of inj ibuprofen and 1 gm of inj paracetamol intravenously.
The operating room will be prepared and anaesthesia machine will be checked. All emergency drugs and equipment will be placed and checked in the operation theatre preoperatively. Standard monitoring with the continuous electrocardiogram , heart rate , non-invasive blood pressure , oxygen saturation will be done and will be started before induction of anaesthesia. An 18 gauge intravenous cannula will be inserted in large vein of dorsum of non-dominant hand and intravenous line and normal saline at 10 ml/kg will be started for preloading. The study drugs will be administered as a single dose, i.e. 15 minutes before spinal anaesthesia. Under strict asepsis, lumbar puncture will be performed at L3-L 4 or L4-L5 spinal interspace, in sitting position, through a standard midline approach using a 26-G Quincke spinal needle. Hyperbaric, bupivacaine 0.5% 15 mg will be injected intrathecally.
The haemodynamics like heart rate , mean arterial pressure , oxygen saturation , will be recorded every 5 minutes during the intraoperative period. Thereafter, the parameters will be observed after every 15 minutes till 2 hours postoperatively and thereafter every 2 hours till 6 hours and then at 12th hour and 24th hour postoperatively in ward.
Pain will be assessed using Visual Analogue Scale. It is linear scale, consisting of 10 cm line anchored at one end by a label such as No pain and other end by Worst pain imaginable. Patient simply marks the line to indicate the pain intensity. Pain intensity will be checked when patient is planned to be shifted to postoperative area. It will be baseline pain intensity and patients will be followed up every 15 minutes for next 2 hours in post operative area. Then after every 2 hours till 6 hours and then at 12th hour and finally at 24th hour in wards. Patients with a VAS score of 3 or more will receive injection Diclofenac sodium 75-mg intramuscularly as rescue analgesia whenever it happens. The study will be over when rescue analgesic is administered or after postoperative 24 hours in the ward. The time from administration of spinal anaesthesia to time of rescue analgesia will be total analgesia duration.
The surgery will be conducted as per procedure and no analgesic will be administered intra-operatively. The patient will be shifted to postoperative room and will be monitored there for next 2 hours and then at 6th hour, 12th hour and 24th hour in the ward for post operative pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •1 ASA class I or II 2 Age from 18 to 70 years either sex 3 Measuring 150 to 180 cm height, with body mass index BMI of 18 to 35 kg per m2 4 Patients undergoing elective and emergency orthopaedic surgeries requiring spinal anaesthesia.
排除标准
- •1 All contraindications to spinal analgesia including bleeding diathesis, infection at the puncture site, spinal deformity, patient on anticoagulants, pre existing neurological deficits in lower extremities, unwillingness to give consent.
- •2 Surgical duration more than 2 hours 3 Sensory blockade inadequate for surgery.
- •4 Patients having cardiac rhythm abnormalities.
- •5 History of alcoholism, drug abuse, and psychiatric disorders.
- •7 Hepatic disease, renal disease, cardiopulmonary disease, hypertension, diabetes, central or peripheral nervous system disorders.
- •8 Chronic pain patients undergoing treatment with opioid analgesic.
- •9 Pregnant patients.
结局指标
主要结局
Pain will be assessed with Visual Analogue Scale between 0 and 10
时间窗: 1 Pain will be assessed with Visual Analogue Scale between o and 10 at every 15 minutes till 2 hours and then after every 2 hours till 6 hours and then after 12th hour and at 24th hour in ward. | 2 Time of onset of T10 sensory block and time to peak sensory block will be noted | 3 Time of onset of Bromage 3 motor block will be noted. | 4 Time of supplemental analgesia administered
次要结局
- 1 To assess the haemodynamics intraoperatively & postoperatively.(2 To assess the adverse effects.)
研究者
Abhinav Rawat
Govt Medical College and Hospital
