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临床试验/CTRI/2024/12/078422
CTRI/2024/12/078422尚未招募Phase 3 4

A comparative study of efficacy and safety of two different doses of dexmedetomidine – 0.5µg/Kg and 1µg/Kg as an adjuvant to 0.25% ropivacaine in ultrasound guided adductor canal block for postoperative analgesia in knee surgeries under spinal anaesthesia

MGM Medical college and hospital1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年1月1日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
入组人数
64
试验地点
1
主要终点
1. To assess and compare postoperative analgesia using the numerical pain rating scale

研究概览

简要总结

Severe postoperative pain is a common complain post knee surgeries, affecting rehabilitation and early mobilization efforts. Regional anaesthesia forms an important part of the solution. regional anaesthesia specific to lower limb surgeries includes femoral nerve block, sciatic nerve block, obturator nerve block, lumbar plexus block and the adductor canal block. Adductor canal block is superior to femoral nerve block (considered the gold standard) in having an added advantage of motor sparing effect, which eliminates quadriceps weakness and thus helps in early mobilization post operatively.

In this study, we aim to primarily assess the efficacy of two different doses of dexmedetomidine 0.5mcg/kg and 1mcg/kg as an adjuvant to 0.25% ropivacaine in ultrasound guided adductor canal block in knee surgeries. And compare the number of rescue analgesics needed. Our secondary objective is to compare the motor blockade, sedation scores and hemodynamic stability between the two groups.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant, Investigator and Outcome Assessor 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

  • posted for elective knee surgeries under spinal anaesthesia ASA grade II and II.

排除标准

  • Allergy to drugs used in study Patients having contraindications to adductor canal blocks(local site infections, coagulopathies) Known neurological deficits.

结局指标

主要结局

1. To assess and compare postoperative analgesia using the numerical pain rating scale

时间窗: 0 MIN (MOMENT BLOCK IS GIVEN) | 30 MIN | 60 MIN | 90 MIN | 120 MIN | 6 HOURS | 12 HOURS | 18 HOURS | 24 HOURS

2. To assess and compare number of rescue analgesics required within 24hrs

时间窗: 0 MIN (MOMENT BLOCK IS GIVEN) | 30 MIN | 60 MIN | 90 MIN | 120 MIN | 6 HOURS | 12 HOURS | 18 HOURS | 24 HOURS

次要结局

  • 1. To assess and compare motor blockade between two groups using modified bromage scale(2. To assess and compare haemodynamic parameters)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr. Ayushi Shastri

MAHATMA GANDHI INSTITUTE OF MEDICAL SCIENCES, AURANGABAD

研究点 (1)

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