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临床试验/NCT05601427
NCT05601427已完成不适用

A Randomized Controlled Trial Assessing the Efficacy of Surgeon-performed, Intraoperative Adductor Canal Blocks in Same-Day Discharge Total Knee Arthroplasty

Ottawa Hospital Research Institute2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年3月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
2
主要终点
Pain medication use

研究概览

简要总结

Adductor canal blocks (ACB) have been recommended in total knee arthroplasty (TKA) to provide better control of post-operative pain, facilitate early ambulation, and reduce length of stay in the hospital. ACB is typically done before surgery by an anesthesiologist, which may increase time per case, cost, and requires the specialized skills of an anesthesiologist trained in regional anesthesia. Recent studies have suggested that surgeons can safely and reliably administer the adductor canal blocks (sACB) during surgery. However, there is currently very limited data on the clinical efficacy of such sACBs, and no studies assessing this technique in the context TKA that are discharged the same day. As such, this randomized control trial (RCT) is being done to compare sACBs to conventional anesthesiologist-performed adductor canal blocks (aACB).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Male and female patients aged 18 years or older
  • Primary TKA booked as SDD
  • Diagnosis of osteoarthritis

排除标准

  • Inability or refusal to sign informed consent form
  • Non-English or French speaking, and no licensed translator, family member or substitute decision maker available.
  • Non-osteoarthritis primary diagnosis
  • Allergy to analgesic medications
  • Contraindication to spinal and/or regional anaesthesia
  • Any use of opioid pain medication within four weeks of the index procedure(13)
  • Pain catastrophizing scale score ≥16 (8, 9, 14)
  • History of cirrhosis
  • History renal insufficiency
  • History or sensory and/or motor neuropathy to the ipsilateral limb
  • Simultaneous, bilateral TKA
  • Non-TKA prosthesis
  • Scheduled for non-SDD TKA.
  • Preoperative varus/valgus of >10 degrees.
  • Planned General Anaesthetic
  • Use of Intrathecal Morphine

研究组 & 干预措施

Anesthesiologist-Performed Adductor Canal Block (aACB)

Active Comparator

Patients will get a pre-operative adductor canal block performed by an anesthesiologist.

干预措施: aACB (Procedure)

Surgeon-Performed Adductor Canal Block (sACB)

Experimental

Patients will get an intra-operative adductor canal block performed by the surgeon

干预措施: sACB (Procedure)

结局指标

主要结局

Pain medication use

时间窗: When spinal anesthesia resolves until 24 hours after surgery

morphine equivalents of pain medication

Patient Report Pain

时间窗: Up to 24 hours

Mean Numerical Pain Rating Scale (NPRS) scores on discharge

次要结局

  • Timed Up and Go Test(At discharge)
  • Patient Reported Quality of Recovery(At 24 hours post-operative)
  • Time to discharge(From PACU to discharge)
  • Patient Reported Function(pre-operatively, at 2 weeks post-operative)
  • Patient Reported Global Health(pre-operatively, at 2 weeks post-operative)
  • Readmission Rate(Up to 24 hours post-operative)
  • Patient Reported Quality of Life(pre-operatively, at 2 weeks post-operative)
  • Admission to Hospital(Up to 24 hours post-operative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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