跳至主要内容
临床试验/NCT04257682
NCT04257682Unknown4 期

Comparing Efficacy and Safety of Three Regional Anesthesia Regimens in Total Hip and Knee Arthroplasty: A Double Blind Randomized Control Trial

Ottawa Hospital Research Institute0 个研究点目标入组 135 人开始时间: 2022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
入组人数
135
主要终点
Compare the effectiveness of Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine: proportion of patients with a failed spinal anesthetic

研究概览

简要总结

The purpose of this study is to test whether the use of Ropivacaine and Mepivacaine are better in terms of effectiveness, cost, and safety than Bupivacaine as regional anesthetics in elective hip or knee replacement surgery.

详细描述

Advances in pain management, regional anesthesia, and focused rehabilitation have increased the popularity of outpatient total hip and knee arthroplasty in a select group of eligible patients. However, one of the main impediments to same-day discharge is the prolonged motor block post-spinal anesthesia, as patients are routinely kept in the post-anesthesia care unit (PACU) until they demonstrate that the spinal anesthesia has worn off.

At The Ottawa Hospital, the standard treatment for people receiving anesthesia during a total arthroplasty is the use of the anaesthetic, Bupivacaine. Mepivacaine and Ropivacaine are alternative anaesthetics that are also in use at The Ottawa Hospital. They are growing in popularity as anaesthetics because they and allow quicker recovery time when compared to Bupivacaine. Bupivacaine results in a long-lasting sensory-motor block, meaning that in the area that the local anesthesia was used, there is no sensation and limited movement for long periods of time. During hip or knee replacement surgery, you may want to have no sensation and the inability to move your lower limbs. However, it is not ideal for after surgery where weakness in the legs puts a person at increased risk for falls. Therefore, hospitalization after surgery typically lasts for a longer duration. Mepivacaine and Ropivacaine have a shorter motor block duration, allowing for a potentially earlier hospital discharge.

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, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients undergoing total hip or knee replacement

排除标准

  • Study refusal
  • Inability to provide consent
  • Contra-indications to spinal anesthesia (refusal, infection, anti-coagulation, bleeding diathesis)
  • Bilateral surgery
  • Revision surgery
  • Pre-exiting chronic pain or opioid consumption ≥ 30mg oxycodone or equivalent
  • Pregnancy
  • Not receiving preoperative adductor canal block for any reason
  • Contra-indication to multimodal analgesia (acetaminophen or NSAIDs)
  • Obstructive sleep apnea requiring extended PACU stay
  • History of severe postoperative nausea and vomiting

研究组 & 干预措施

Bupivacaine

Active Comparator

The participant will receive Bupivacaine as anesthesia during his or her planned total hip or knee replacement surgery.

干预措施: Bupivacaine (Drug)

Ropivacaine

Active Comparator

The participant will receive Ropivacaine as anesthesia during his or her planned total hip or knee replacement surgery.

干预措施: Ropivacaine (Drug)

Mepivacaine

Active Comparator

The participant will receive Mepivacaine as anesthesia during his or her planned total hip or knee replacement surgery.

干预措施: Mepivacaine (Drug)

结局指标

主要结局

Compare the effectiveness of Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine: proportion of patients with a failed spinal anesthetic

时间窗: Day of surgery

Effectiveness will be measured by looking at the proportion of patients with a failed spinal anesthetic.

Compare the cost profile of Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine.

时间窗: Hospital discharge, approximately 1 day

Total costs associated with the providers involved and the costs associated with the time spent in the hospital following surgery but before discharge will be combined to report the cost profile

次要结局

  • Compare changes in post-operative pain associated with Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine.(Immediately after completion of surgery, every hour during PACU stay - approximately 3 hours, every 6 hours during hospital stay - approximately 1 day, 24 hours after surgery, one week post-operatively)
  • Compare the safety of Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine.(24 hours after surgery, one week post-operatively)
  • Compare the quality of the block provided by Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine.(During surgery, PACU discharge - approximately 3 hours)
  • Compare the length of stay for patients who received Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine.(Immediately after surgery, PACU discharge - approximately 3 hours, SDC discharge - approximately 1 day, hospital discharge - approximately 1 day)

研究者

申办方类型
Other
责任方
Sponsor

相似试验

Regional Anesthesia in Total Hip and Knee... | 临床试验