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临床试验/CTRI/2021/02/031366
CTRI/2021/02/031366尚未招募不适用

A Comparative study between ropivacaine and dexmedetomidine vs levobupivacaine and dexmedetomidine for post-operative analgesia using adductor canal block in patients undergoing total knee replacement surgeries.

Army Hospital Research and Referral1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年3月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
1.Time to first demand of rescue analgesia

研究概览

简要总结

1.All patients undergoing surgery will be explained about study and informed written duly signed consent will be taken.

2.Patient will be randomly allocated to Group R(0.375% Ropivacaine + Dexmedetomidine 0.5 mcg/kg) or Group L ( 0.25% Levobupivacine + Dexmedetomidine 0.5 mcg/kg) consisting of 30 patients each.

3.After conclusion of the unilateral knee replacement surgery, patients will be monitored for  HR,NIBP, ECG and SpO2  prior to block.

4.After proper positioning  Adductor Canal will be identified using Ultrasound and 20ml of drug will be injected in the canal. The plane of drug spread between sartorius and the femoral artery will be seen real time on ultrasound.

5.The patients will be observed for 60 min post procedure in the post anaesthesia recovery room. HR,NIBP and SpO2 will be monitored continuously and noted at 15 min interval for the 1st hour after the block and then 2 hourly for 24 hrs and response of VAS (0-10) for post-operative analgesia will be recorded.

6.Inj Tramadol (1.5mg/kg) will be used as first rescue analgesia and time duration for its demand and total consumption of tramadol, diclofenac and paracetamol in 24 hours postoperatively will be noted.

7.Overall satisfaction score of patient will be recorded on a scale of 1-10.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
30.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • 1.Age 30-75 yrs.
  • 2.American society of anestheiologists(ASA) grade I- III.
  • 3.Written Informed Consent for the procedure.

排除标准

  • 1.American society of anestheiologists(ASA) grade 1V.
  • 2.Age <30 and >75 yrsPatients with BMI > 30 Kg/m2 .
  • 3.Patient refusing block.
  • 5.Patient with history of psychiatric disease on psychotropic medication.
  • 6.History of medical conditions like, bleeding diatheses and local skin site infection.
  • 7.History of alcohol or drug abuse 8.Uncooperative patient.

结局指标

主要结局

1.Time to first demand of rescue analgesia

时间窗: 24 hours

3.Rescue analgesic consumption (total in 24 hrs).

时间窗: 24 hours

2.Duration of analgesia

时间窗: 24 hours

次要结局

  • 1.Onset and duration of motor block (if any).(2.Patient satisfaction score on a numeric scale (0-10 ‘0’ being not)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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