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临床试验/NCT03954379
NCT03954379已完成4 期

Opioid Sparing Analgesic Strategies for Enhanced Recovery After Total Knee Arthroplasty

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2019年10月24日最近更新:
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
78
试验地点
1
主要终点
postoperative opioid consumption in MG

研究概览

简要总结

This study proposes to compare current multimodal analgesic treatment for TKA with a new multimodal analgesic regimen to demonstrate decreased opioid requirement, time to rehabilitation, and time to reach hospital discharge.

详细描述

Total knee replacement surgery (TKA) causes severe pain and this procedure is the most common reason patients are prescribed strong opioid drugs in hospital. As a result they are slow to begin rehabilitation after surgery, and are late in hospital discharge. Ontario hospitals are constantly challenged to meet growing demands of TKA and in fact increased demand has overcome the health care system resulting in TKA wait time (Ontario actual: 286 days vs. target: 182 days).1 One strategy to accommodate expanding volume and reduce wait time is to reduce hospital length of stay (LOS) through an enhanced recovery program.2 One essential component is further improvement of postoperative pain treatment to expedite rehabilitation and hospital discharge.

Treatment of severe post TKA pain often requires potent opioids but their excessive and prolonged use has negative consequences e.g., increased perioperative adverse events and longer LOS.3 Approximately 8% of opioid naive TKA patients become chronic opioid users at 6 months and the duration of prescription is the strongest predictor of misuse.4 Knowing that the opioid crisis in Canada is steadily growing and prescription opioids play a significant role in dependence and misuse,5 an effective perioperative opioid minimization analgesic program is mandatory for TKA patients.

Current multimodal analgesic treatment for TKA consists of oral non opioid drugs e.g., acetaminophen and non steroidal anti-inflammatory agents (NSAIDs) and surgeon performed peri-articular local anesthesia infiltration, however this is only partially effective.6 The regional analgesic effect is often short lived (< 8 hours). Failure to sustain effective analgesia necessitates continued heavy reliance on opioids.

Several new treatments have been recently described for post TKA pain. They are: IV dexamethasone (steroid),7 dexmedetomidine (alpha 2 agonist)8, ketamine (NMDA antagonist)9 and 2 novel nerve block procedures- adductor canal block10 and iPACK block (infiltration between popliteal artery and posterior capsule of the knee).11 While each individual intervention has demonstrable analgesic benefit, the impact of incorporating all new treatments into the current analgesic regimen remains unknown.

The investigators believe that the new multimodal analgesic regimen proposed in this study will significantly decrease opioid requirement, time to rehabilitation, and time to reach hospital discharge criteria. It may also decrease the duration of opioid prescription for pain relief after hospital discharge. Although investigator's preliminary experience with this new regimen in 10 patients is promising, robust evidence showing its sustained opioid sparing analgesic effect is lacking.

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)

盲法说明

Block room and anesthesia staff performing nerve blocks and administering sedation will be informed to which study group patient is allocated. The patient and independent investigator carrying out follow up assessments will remain blinded to the end of the study. If the patient wishes to know the study group assignment, the patient will be informed at the end of their final 6 week follow up.

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Group C ( Comparator Group )

Active Comparator

Standard of care: Adductor Canal Block(ACB), Spinal Anesthesia (SA) and Peri-op Pain management

干预措施: Standard of Care (ACB, SA, peri-op pain management) (Drug)

Group C ( Comparator Group )

Active Comparator

Standard of care: Adductor Canal Block(ACB), Spinal Anesthesia (SA) and Peri-op Pain management

干预措施: Periarticular Local Anesthetic Infiltration (Procedure)

Group C ( Comparator Group )

Active Comparator

Standard of care: Adductor Canal Block(ACB), Spinal Anesthesia (SA) and Peri-op Pain management

干预措施: IV Dexamethasone 8mg at the end of surgery as standard of care (Drug)

Group S ( Study Group )

Experimental

iPACK and multi-modal analgesic regimen

干预措施: IV Dexamethasone 8mg at the end of surgery as standard of care (Drug)

Group S ( Study Group )

Experimental

iPACK and multi-modal analgesic regimen

干预措施: IPACK and multi-modal analgesic regimen (Drug)

Group S ( Study Group )

Experimental

iPACK and multi-modal analgesic regimen

干预措施: Periarticular Local Anesthetic Infiltration (Procedure)

结局指标

主要结局

postoperative opioid consumption in MG

时间窗: 24 hours

Cumulative 24 hour oral hydromorphone and oxycodone equivalent consumption

次要结局

  • Incidence of adverse events related to nerve block procedures(Post-op 24 to 72 hours)
  • Incidence of adverse events related to opioid consumption(Post-op 24 to 72 hours)
  • Opioid consumption in MG(12 hours to 6 weeks after surgery)
  • Quality of Recovery (QoR) assessed using a validated QoR-15 tool ( Total score range- 0 to 150, higher values represent a better outcome)(Baseline, 24-hour, 48-hour and 2-weeks after surgery)
  • Time to reach physical therapy milestones in hours(0-72 hours after surgery)
  • Pain scores at rest using numerical rating scale (NRS, 0 to 10)(0-48 hours after surgery)
  • Time to reach hospital discharge criteria in hours(24 to 72 hours after surgery until discharge)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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