Randomized Controlled Trial Comparing Spinal Anesthesia With 1% Chloroprocaine Versus 1% Mepivacaine in Patients Undergoing Outpatient Primary Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 170
- 主要终点
- Time to complete recovery of motor block
研究概览
简要总结
This study or clinical trial looking to compare 2 types of freezing medications injected into the spinal fluid at the lower back between the vertebrae in patients going to have total knee replacement surgery to check for early legs movement, early discharge from recovery room, walking and hospital discharge. This could save hospital cost of such procedures.
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
- Single (Care Provider)
盲法说明
Surgeons, PACU Nurses, OR Nurses, Physical therapists
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I-III
- •Elective outpatient TKA
- •BMI less than 40
- •Ability to provide surgical consent
排除标准
- •Patient refusal
- •Opioid tolerant
- •Any contraindications to spinal anesthesia
- •Chronic opioid use 3months or more
研究组 & 干预措施
One arm receives spinal Mepivacaine 50 mg
One arm receives spinal Mepivacaine 50mg for total knee arthroplasty with adductor canal block
干预措施: Mepivacaine Injection (Drug)
Spinal Chloroprocaine group
干预措施: Chloroprocaine Injection (Drug)
结局指标
主要结局
Time to complete recovery of motor block
时间窗: Time from the intrathecal drug injection to the first documented instance of complete motor block recovery Bromage 0. Within approximately 2 hours for the Chloroprocaine group and 4 hours for the Mepivacaine group.
Time to complete motor block recovery of lower limbs after spinal anesthesia
时间窗: From the time of intrathecal drug injection to PACU discharge. Within approximately 3 hours for the Chloroprocaine group and 5 hours for the Mepivacaine group.
Motor block will be assessed by PACU nurses in PACU using standard Bromage motor scale.
次要结局
未报告次要终点
研究者
Husam Nashnoush
Doctor Husam Nashnoush, MBBCH, FRCPC, Anesthesia Department, Central Zone, DGH, Halifax , NS
Nova Scotia Health Authority