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临床试验/CTRI/2024/06/069194
CTRI/2024/06/069194尚未招募4 期

Comparison of analgesic efficacy of pre-emptive paracetamol, ibuprofen and paracetamol-ibuprofen in orthopedic surgeries.

Government Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2024年6月30日最近更新:

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

发起方
Government Medical College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Abhinav Rawat

Govt Medical College and Hospital

研究点 (1)

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