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临床试验/CTRI/2025/02/080423
CTRI/2025/02/080423尚未招募4 期

A Randomized control Trail Comparing Post operative Analgesic Effect of Dexmeditomidine vs Nalbuphine as an Adjuvant with Ropivacaine in USG Guided Adductor Canal Block in Patients Undergoing Knee Surgeries

SRM MEDICAL COLLEGE AND RESEARCH INSTITUTE1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年2月22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
120
试验地点
1
主要终点
Time to first rescue analgesia demand. If VAS score more than 3 Inj.paracetamol and if VAS 3-6 Inj. tramadol 100mg in 100ml NS.

研究概览

简要总结

A total of 120 patients belonging to age group 18 to 65 years  , ASA class I and II scheduled for knee procedures will be prospectively studied. In this double-blinded randomized control trial,a total of 120 participants will be allocated into three groups -  Randomisation into 3 groups by computer generated randomisation  –Group D,Group N,GROUP R. GROUP D- Patients receive Inj. Ropivacaine 0.5% 20ml +Inj. Dexmedetomidine 50mcg/kg.GROUP N- Patients receive Inj. Ropivacaine 0.5% 20ml + Inj. Nalbuphine 10ml.Group R – Patients receive Inj.ropivacaine0.5% plain 20ml  +10ml of distilled water.Under ASP, spinal anesthesia given with 0.5% of bupivacaine(H) 3ml @L3-L4 space with Quincke 25g needle to the assigned group.Under ASP, Adductor canal block will be given to the assigned  group.Post operative pain will be assessed for the 1st 24 hours.Data collection will be done by observation and measurement of various parameters.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Age 18-65 ASA PS 1-2 All patients undergoing knee surgeries.
  • Both sexes.

排除标准

  • Patient refusal Contraindications to regional nerve block: Cellulitis / infection at the local site Coagulopathy Allergy to local anaesthetic agents Patients with pre existing nerve injury.

结局指标

主要结局

Time to first rescue analgesia demand. If VAS score more than 3 Inj.paracetamol and if VAS 3-6 Inj. tramadol 100mg in 100ml NS.

时间窗: 1st hour,2nd hour,3rd hour,4th hour,5th hour,6th hour,12th hour,18th hour,24th hour

次要结局

  • Requirement of total analgesic doses in first 24hours.(VAS score for first 24hours)

研究者

发起方
SRM MEDICAL COLLEGE AND RESEARCH INSTITUTE
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr T Shalini

SRM Medical College and Research Institute

研究点 (1)

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