Adductor Canal Block With Continuous Infusion Versus Intermittent Boluses and Morphine Consumption: A Randomized, Triple-masked, Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Total opioid consumption
研究概览
简要总结
The investigators believe sufficient spread to all nerves within the adductor canal-and thereby sufficient analgesia-can only be obtained by bolus injections and not by continuous infusions via a catheter. The aim of the study is to investigate whether an adductor canal block performed as repeated intermittent boluses provides superior pain relief to continuous infusion. The investigators hypothesize that adductor canal block performed as intermittent boluses via a catheter will reduce morphine consumption and pain as well as enhance ambulation and muscle strength compared with continuous infusion.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Patients scheduled for total knee arthroplasty in spinal anesthesia
- •Patients who gave their written informed consent to participating in the study after having fully understood the contents of the protocol and restrictions
- •American society of anesthesiologists 1-3
- •Ability to perform a timed up and go test preoperatively
排除标准
- •Patients who cannot cooperate
- •Patients who cannot understand or speak Danish.
- •Patients with allergy to the medicines used in the study
- •Patients with a daily intake of strong opioids (morphine, oxycodone, ketobemidone, methadone, fentanyl) during the last 4 weeks
- •Patients suffering from alcohol and/or drug abuse - based on the investigator's assessment
- •Rheumatoid arthritis
- •BMI > 40
- •Neuromuscular pathology in the lower limbs
- •Pregnancy
研究组 & 干预措施
Intermittent bolus
ropivacaine 0.2%, 21 ml every 3 hours
干预措施: ropivacaine 0.2% (Drug)
Continuous infusion
ropivacaine 0.2%, 7ml/h
干预措施: ropivacaine 0.2% (Drug)
结局指标
主要结局
Total opioid consumption
时间窗: 2 days postoperative
Difference in total opioid consumption (patient controlled analgesia pump and any potential rescue administration) between groups, from end of surgery until 12 pm on postoperative day (POD) 2.
次要结局
- Pains scores during knee flexion as assessed by the Visual analogue scale (VAS)(2 days postoepratively)
- 6 min walk test(1 and 2 days postoperativley)
- Quadriceps strength assessed as maximum voluntary isometric contraction in percentage of preoperative baseline values at 12 pm on POD 1 and 2(1 and 2 days postoperatively)
- Timed Up and Go test(1 and 2 days postoperatively)
- Number of patients able to perform the Timed Up and Go test(1 and 2 days postoperatively)
- Pain at rest as assessed by the VAS pain scores(2 days postoperatively)
- Pain during the Timed Up and Go test as assessed by the VAS(1 and 2 days postoperatively)
研究者
Pia Jaeger
Sponsor-Investigator
Rigshospitalet, Denmark