跳至主要内容
临床试验/CTRI/2023/05/052455
CTRI/2023/05/052455尚未招募不适用

Evaluation of the analgesic effect of fentanyl as an additive to intrathecal hyperbaric ropivacaine for lower limb surgery

Dr. Sarvjeet Kaur1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年5月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
1.To study duration of analgesia with intrathecal ropivacaine in lower limb surgery.

研究概览

简要总结

INTRODUCTION: Spinal anaesthesia has been a widely used, safe and effective form of anaesthesia for lower abdominal and extremity surgeries. Intrathecal ropivacaine as a local anaesthetic drug has been introduced into clinical practice as it meets the desired goals of anaesthesia while minimizing the potential side effects. The addition of different adjuvants along with local anaesthetic has shown to have synergistic effect by prolonging the analgesic property and the duration of sensory-motor blockade and decreasing the dose requirement of local anaesthetic. Fentanyl in this regard has also shown some promising effects. The addition of intrathecal fentanyl to ropivacaine may improve the quality of block and early postoperative mobility. Thus we compare the use of ropivacaine along with an adjunct (fentanyl) versus a single agent to attain the desired anesthetic effect while minimizing the associated side effects.

AIMS AND OBJECTIVES: Our aim is to compare analgesic efficacy of intrathecal ropivacaine with fentanyl versus ropivacaine alone in lower limb surgeries.We will compare the onset and duration of sensory blockade and motor blockade and maximum height of sensory blockade achieved. We will also look for safety and side effects, if any in both the groups.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Outcome Assessor Blinded

入排标准

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

入选标准

  • 1.Patients scheduled for elective lower limb surgeries under spinal anaesthesia.
  • 2.Patients aged between 18-60 years of either gender, giving valid informed and written consent.
  • 3.Patients belonging to American Society of Anaesthesiology (ASA) grade I and II.

排除标准

  • 1.Patient with Known allergy to drugs used in study 2.Any contraindications to spinal anaesthesia 3.Coagulopathy and bleeding diathesis 4.Patients diagnosed with psychiatric ailments 5.History of drug/substance abuse 6.Patients on anti arrhythmic treatment BMI>35 kg/m2.

结局指标

主要结局

1.To study duration of analgesia with intrathecal ropivacaine in lower limb surgery.

时间窗: Outcome will be assessed at the end of study that is 12 months

2.To study duration of analgesia with intrathecal ropivacaine and fentanyl in lower limb surgery.

时间窗: Outcome will be assessed at the end of study that is 12 months

3.To compare duration of analgesia with intrathecal ropivacaine versus intrathecal ropivacaine with fentanyl in lower limb surgery.

时间窗: Outcome will be assessed at the end of study that is 12 months

次要结局

  • NA(NA)

研究者

发起方
Dr. Sarvjeet Kaur
申办方类型
Other [self]

研究点 (1)

Loading locations...

相似试验