跳至主要内容
临床试验/CTRI/2021/05/033463
CTRI/2021/05/033463尚未招募1/2 期

A comparative study to know the efficacy of intrathecal nalbuphine versus intrathecal fentanyl as an adjuvant to bupivacaine for lower limb surgeries

Shri B M Patil Medical College1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年5月17日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
入组人数
70
试验地点
1
主要终点
To compare the onset and duration of sensory and motor blockade of fentanyl and nalbuphine adjuvant to bupivacaine.

研究概览

简要总结

During preoperative visit patient’s detailed history,general physical examination and systemic examination will be carried out.History of any significant medical illness will be elicited. Airway,respiratory system and cardiovascular system will be assessed.

Only ASA grade І and ІІ patients withinthe age group of 18 to 60 years of either sex undergoing elective lower limb surgerieswill be included in our study. A written informed consent will be taken.

Patientwill be shifted to operation table, IV access will be obtained on forearm with18 Gauge IV cannula and Ringer’s lactate solution 500ml will be infused intravenouslybefore the block. The monitors will be connected to patient which include non-invasiveblood pressure. Oxygen saturation using pulse oximeter.  Baseline PR, BP and SpO2 will be recorded.

Under strict aseptic precautions, lumbarpuncture will be performed in left lateral position by midline approach byusing 26G Quincke spinal needle at L3-L4 intervertebral space and study drugwill be injected intrathecally after confirming clear free flow of CSF. Patient’svitals will be monitored continuously using mutli-parameter monitor. Afterspinal anaesthesia, Oxygen (5L/min) by facemask will be given, Fluid therapywill be maintained with Lactated Ringer’s solution (10ml/kg/hr).

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Adult patients aged between 18-60 years of both sex undergoing elective lower limb surgeries.
  • Patients belonging to ASA Grade І and ІІ.

排除标准

  • Infection at the site of injection.
  • Hypersensitivity to study drugs.
  • Coagulopathy or other bleeding diathesis.
  • Patients with peripheral neuropathy.
  • Patients with cardiac, pulmonary, hepatic or renal disorder.

结局指标

主要结局

To compare the onset and duration of sensory and motor blockade of fentanyl and nalbuphine adjuvant to bupivacaine.

时间窗: At 0, 5, 10, 15, 30, 60 and 120 minute and time of rescue analgesia.

次要结局

  • To compare the haemodynamic changes like heart rate and blood pressure, Time of rescue analgesia and Side effects of study drugs.

研究者

申办方类型
Private medical college

研究点 (1)

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