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IPACK Block in Total Knee Arthroplasty

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合作者:
信息的提供 (责任方):
Alexandros Makris,Asklepieion Voulas General Hospital
September 30, 2018
October 2, 2018
October 4, 2018
October 2018
June 2019   (主要结果测量的最终数据收集日期)
NRS scores[ Time Frame: 48 hours ]
Numerical Rating Scale (NRS) scores (Range 0-10, 0=no pain, 10=the worse pain ever)

Morphine consumption[ Time Frame: 24 hours ]
Morphine consumption in mg

Chronic pain[ Time Frame: 6 months ]
Using of Graded Chronic Pain Scale (GCPS) Grade 0: No pain in prior 6 months Grade 1: Low Intensity - Low Disability Grade II: High Intensity Characteristic Pain Intensity - Low Disability Grade III: High Disability - Moderately Limiting Grade IV: High Disability - Severely Limiting

与当前相同
  • Delirium occurence[ Time Frame: 48 hours ]
    Nu-DESK scale (presence of disorientation, inappropriate behavior, inappropriate communication,illusions/hallucinations, psychomoter retardation). Each of the 5 items is rated from 0 to 2. A total of 10 is the maximum score. A score of more than 2 identifies the presence of delirium.
  • Range of knee motion[ Time Frame: 48 hours ]
    Degrees of flexion
  • Complications[ Time Frame: 48 hours ]
  • Patient mobilization[ Time Frame: 5 days ]
    Patient reporting time of first standing to the side of the bed and number of steps per day
  • Patient satisfaction[ Time Frame: 48 hours ]
    Patients asked whether they would choose the same anaesthetic management in a future operation: Yes/No
  • Joint function[ Time Frame: 6 months ]
    Maximal flexion / extension
  • Intestinal function[ Time Frame: 5 days ]
    Time of first passing of rectal gas, reported by the patient
 
IPACK Block in Total Knee Arthroplasty
IPACK Block Efficacy as a Part of Multimodal Analgesia in Total Knee Arthroplasty. A Prospective, Randomized, Controlled, Double Blinded Study

100 patients ASA I-III, undergoing total knee arthroplasty under spinal anesthesia, will be randomly assigned into one of two groups, namely group A (n=50), where an adductor canal block and an IPACK block will be performed preoperatively and group B (n=50) where an adductor canal block only will be performed preoperatively. All patients will receive a standardized multimodal approach, including pregabalin, paracetamol, and PCA with morphine. NRS scores in static and dynamic conditions during the first 48 hours postoperatively, morphine consumption during the first 24 hours postoperatively will be measured and additionally, patient satisfaction, complications, range of knee motion, moblization, functionality, delirium ocurence will be recorded. Chronic pain will be assessed in 3 and 6 months postoperatively.

Interventional
Phase 2
分配: Randomized
干预模型: Parallel Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Treatment
  • Drug: Adductor Canal Block plus IPACK Block
    Adductor Canal Block plus IPACK Block using Ropivacaine
  • Drug: Adductor Canal Block
    Adductor Canal Block using Ropivacaine
  • Active Comparator: Group A
  • Active Comparator: Group B
 
Not yet recruiting
100
与当前相同
July 2019
June 2019   (主要结果测量的最终数据收集日期)
Inclusion Criteria: - Physical status according to American Society of Anesthesiologists (ASA) I-III - Patients scheduled for total knee arthroplasty Exclusion Criteria: - Previous operation on same knee - Contraindication of spinal anesthesia, peripheral nerve blocks or any of the agents used in the protocol - BMI above 32 - Serious psychiatric, mental and cognitive disorders - Language barrier - Block failure - Chronic opioid, gabapentinoid use - Severe kidney disfunction
参与研究的性别: All
最小年龄:14 Years ,最大年龄:80 Years  
没有
 
Yes
研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No
计划分享 IPD:
Alexandros Makris,Asklepieion Voulas General Hospital
Asklepieion Voulas General Hospital
:
Asklepieion Voulas General Hospital
October 2018

ICMJE     国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素
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