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临床试验/NCT01667445
NCT01667445已完成4 期

Determination of Effectiveness of Periarticular Local Infiltration When Compared to Spinal Epimorph for Analgesia in Total Knee Arthroplasty

Lawson Health Research Institute1 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2012年9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
113
试验地点
1
主要终点
visual analogue scale for pain

研究概览

简要总结

The purpose of this study is to determine the contribution of spinal epimorph to patient's perioperative pain management in Total Knee Arthroplasty (TKA). This study is designed to determine whether spinal epimorph and its associated complications is a necessary addition to provide adequate analgesia given the multimodal approach to pain management. It is hypothesized that perioperative local infiltration with a cocktail of local and systemic analgesics will provide equal analgesia to patients who are given both local infiltration and spinal epimorph perioperatively.

详细描述

This will be a randomized control trial comparing two patient populations obtained from patients who will receive a primary total knee arthroplasty at LHSC University Campus. Patient participants will be recruited and consented from the arthroplasty clinic and from the preadmit clinic at University Hospital. Both the patients and those measuring the primary outcome, namely, visual pain scales will be blinded to the experimental treatment received.

Patients will be randomized to receive either a spinal with epimorph (150ug) or a spinal with no epimorph at the time of their total hip arthroplasty. This is determined as a result of a computer generated randomization within blocks of 10 (every 10 patients there will be an even number of patients within each group). As each patient signs up they are given a consecutive study number which will determine which group they are assigned to. Note should be made that at the current time patients undergoing total joint arthroplasty may or may not receive epimorph preoperatively depending on their anaesthesiologist (personal communication with Sue Ganapathy) and so both treatment arms represent the current standard of care at LHSC. Again, spinal epimorph is currently being administered for total joint replacement, irregardless of whether or not this study is being done. It is an acceptable standard of care analgesic that is available to each anesthetist should they choose to use it. Many choose to use it as they feel it improves analgesia in patients undergoing total joint arthroplasty, which are recognized as very painful procedures (especially total knees). This is no different that one anesthetist preferring to use dilaudid for pain control and another choosing to use morphine. Both are within accepted standard of care guidelines and it is up to the individual staff to utilize the drug they feel is most beneficial. This decision is based on each individual consultant's interpretation of the available literature as well as their personal practice experience. I hope this justifies our study as we are not introducing any new treatment. Patients will receive spinal epimorph whether or not we conduct this study. As such, no formal study discontinuation rules are applicable. Both patient groups will receive medical treatment as required around the time of their procedure.

Both groups of patients will receive standardized preoperative analgesia including gabapentin (600mg), acetaminophen (975 mg) and naprosyn (500mg). Both groups will receive local anaesthesia in the form of local infiltration of the wound with a previously studied cocktail of morphine, ketoralac, epinephrine and ropivicaine. (3) Post operatively patients will remain on PCA until post operative day one and then will be changed to a standardized oral protocol including long and short acting narcotics on a PRN basis, acetaminophen (975 mg Q6h x 48hrs and then on a PRN basis), naproxyn (500mg BID x 7 days) and gabapentin (300mg BID x 7 days).

Postoperatively visual analogue pain scales will be recorded at 6, 12, 18, 24, 36 and 48hrs as well as at 1 week. Foley usage, oxygen usage, nausea/vomiting and use of antiemetics and antipruritics will also be carefully documented. Both patient groups will receive the standard post operative physiotherapy and will be discharged home with a prescription for the narcotic or analgesics that were providing them with suitable analgesia during their hospital stay.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
40 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients must receive a primary total knee arthroplasty

排除标准

  • Inability to have a spinal anaesthetic
  • Intolerance to narcotic pain medication
  • Inability to use a Patient Controlled Analgesia
  • Revision total knee arthroplasty

研究组 & 干预措施

epimorph

Experimental

single dose administration of 150mcg epimorph

干预措施: Epimorph (Drug)

spinal analgesia

Active Comparator

spinal alone

干预措施: Spinal analgesia (Drug)

结局指标

主要结局

visual analogue scale for pain

时间窗: 1 week post-operatively

次要结局

  • patient report of nausea(48hours post-operatively)
  • patient report of pruritus(48hours post-operatively)
  • catheterization requirements(48hours post-operatively)

研究者

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

James Howard

Orthopaedic surgeon

Lawson Health Research Institute

研究点 (1)

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