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