跳至主要内容
临床试验/CTRI/2021/07/034908
CTRI/2021/07/034908尚未招募不适用

A prospective randomized clinical study to compare the effect of buprenorphine and fentanyl as adjuvants tobupivacaine for post operative epidural analgesia in lower limb orthopedic surgeries.

BLDE deemed to be university1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年7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
60
试验地点
1
主要终点
VAS score less than 5 after administration of epidural drug.

研究概览

简要总结

During the above study period 60 patients posted for lower limb orthopedic surgeries will undergo Spinal anesthesia + Epidural analgesia. Pre-anesthetic evaluation will be done . patients will be shifted to Ot and all standard monitors attached. Patient will be premedicated with Ondansetron 4mg IV. In supine or lateral position 20G portex epidural catheter will be inserted via an 18G Tuohy needle by loss of resistance to air technique and fixed after giving test dose. A 25G spinal needle will  be inserted in l3 l4 interspace and after confirming free flow of csf spinal anesthesia given with bupivacaine. patient monitored intraoperatively . In the post-operative period when patient complains of pain and VAS score is above 5 study drug will be given through epidural catheter

Group A- 2ml 0.5% bupivacaine + 1.5mcg/kg buprenorphine diluted with distilled water upto 10ml

Group B- 2ml bupivacaine + 1mcg/kg fentanyl diluted with distilled water upto 10ml

the patient pulse rate , blood pressure ans vas score will be recorded every 5 minutes for first half hour followed by every hour.

研究设计

研究类型
Interventional
分配方式
Adaptive randomization, such as minimization
盲法
Not Applicable

入排标准

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

入选标准

  • ASA 1 and 2 only.

排除标准

  • patient refusal.
  • contraindication for epidural .
  • pregnant women.
  • cardiorespiratory , hepatic, renal , neurological , blood disorders.
  • Deformities of spine.
  • ASA 3 and 4.

结局指标

主要结局

VAS score less than 5 after administration of epidural drug.

时间窗: Postoperative every 5minutes til first hour and then hourly for 24hours.

次要结局

  • hemodynamic outcomes after drug administration and any adverse effects(postoperatively every 5minutes for first hour and then hourly for 24hours)

研究者

发起方
BLDE deemed to be university
申办方类型
Private medical college

研究点 (1)

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