跳至主要内容
临床试验/NCT00901628
NCT00901628已完成4 期

Efficacy and Safety of Periarticular Multimodal Drug Injections in Total Knee Arthroplasty

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2008年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
101
试验地点
1
主要终点
Pain( Visual Analog Scale )

研究概览

简要总结

The purpose of this study is to determine whether periarticular multimodal drug injection (PMDI) would provide additional benefits in patients after total knee arthroplasty (TKA) for whom contemporary pain control protocols using the continuous femoral nerve block, intra-venous patient controlled analgesia (IV-PCA)and preemptive oral medications. We hypothesized that PMDI would reduce pain level and consumption of PCA and acute pain rescuer and would provide better functional recovery and patient satisfaction. We also hypothesized that the incidence of side effects and complications of the PMDI would be similar to the No-PMDI.

详细描述

The preemptive multimodal approaches are regarded as a current standard pain management protocol. Recently, periarticular multimodal drug injection (PMDI) has been considered to be one of the most effective and important component in multimodal approaches. Because the contemporary pain management protocol using the regional anesthesia, continuous femoral nerve block (FNB) and intravenous patient-controlled analgesia (PCA) has been proved significantly improved analgesic effects itself, little information whether the PMDI would provide additional pain relief under this pain management protocol is available. Also, because the safety of the high dose local anesthetics and narcotics has not been clarified, a selective application should be considered to patients who were expected to show better analgesia if there were certain patient related factors to predict the additional pain relief effect of the PMDI. Thus, this prospective double-blind randomized study was conducted to determine whether PMDI would provide additional benefits in patients after total knee arthroplasty (TKA) for whom contemporary pain control protocols using the continuous femoral nerve block, IV-PCA and preemptive oral medications in terms of pain relief, consumption of PCA and acute pain rescuer, patients satisfaction, functional recovery, side effects and complications.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 81 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of primary osteoarthritis
  • Scheduled for elective total knee arthroplasty
  • Signed written informed consent
  • Spinal anesthesia

排除标准

  • Patients refusing consents
  • inability to use the outcome assessment tools
  • Contraindications to regional anesthesia
  • severe cardiovascular disease
  • allergy or contraindication to drugs used in this study
  • pre-existing neurologic disease including psychiatric disorder
  • drug abuser

研究组 & 干预措施

Periarticular Injection group

Experimental

Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime

干预措施: ropivacaine (Drug)

Periarticular Injection group

Experimental

Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime

干预措施: morphine sulfate (Drug)

Periarticular Injection group

Experimental

Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime

干预措施: ketorolac (Drug)

Periarticular Injection group

Experimental

Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime

干预措施: epinephrine (Drug)

Periarticular Injection group

Experimental

Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime

干预措施: cefuroxime (Drug)

结局指标

主要结局

Pain( Visual Analog Scale )

时间窗: the night after surgery

An independent investigator who was blinded to randomization assessed pain level using 0 to 10 visual analog scale (VAS) that ranged from 0 (no pain) to 10 (worst imaginable pain)at the night after operation.

次要结局

  • Intravenous Patient Controlled Analgesia(PCA) Consumption During 24 Hours After Surgery(24 hours postoperative)
  • Participant Number of Postoperative Nausea and Vomiting During 24 Hours After Surgery(24 hours after surgery)
  • the Proportion of Patients Who Were Satisfied With the Pain Management(postoperative 7 day)
  • The Proportion of Patients Who Could Raise Leg With Replaced Knee Extended(24 hours postoperative)
  • Maximal Flexion Angle Degree on Postoperative 7 Day(postoperative 7 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tae Kyun Kim

Joint reconstruction center, Dept. of orthopaedic surgery

Seoul National University Hospital

研究点 (1)

Loading locations...

相似试验