Adductor Canal Block: Single Injection vs Catheter for Pain Management of Total Knee Arthroplasty - A Randomized, Unblinded, Non-Inferiority Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 180
- 主要终点
- Cumulative 24 Hour Oral Morphine Equivalent Consumption
研究概览
简要总结
This study investigates single injection adductor canal block (ACB) with or without intravenous dexamethasone and adductor canal catheter for pain management of total knee arthroplasty. This is a non-inferiority trial seeking to determine whether single injection ACB with dexamethasone is "no worse" than a continuous catheter.
详细描述
- Purpose
To determine whether single shot adductor canal nerve blocks with intravenous dexamethasone are non-inferior to continuous adductor canal blockade. 2. Hypotheses
The use of adductor canal nerve block with intravenous dexamethasone will not be inferior to continuous adductor canal blockade for opioid requirements 24h post operatively.
The single injection adductor canal block without dexamethasone will have the most opioid consumption. The dexamethasone and catheter groups will be superior to single injection alone in terms of 12 and 48h opioid consumption, length of stay, anti-emetic usage, pain score and quality of recovery score. 3. Justification
Total knee arthroplasty is a very commonly performed operation in North America, with a high propensity for postoperative pain. Inadequate analgesia limits functional recovery and leads to delays in hospital discharge, as a result of poor mobility. Effective analgesia allows for earlier mobilization and improved postoperative recovery, with a multi-modal regime being the ideal method to achieve this.
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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over or equal to the age of 18 years old who can understand the study protocol and are able to give consent
- •Patients with an American Society of Anaesthesiology (ASA) classification 1 to 3
- •Patients must have a preoperative oral 24 hour opioid consumption of less than or equal to 30 mg morphine equivalents
- •Patients must be able to understand and be able to use patient controlled analgesia
- •Patients must be undergoing a primary total knee arthroplasty with neuraxial anesthesia
排除标准
- •Patients with a contraindication to neuraxial and/or regional anaesthesia
- •Patients with an allergy to local anaesthetics
- •Patients who have chronic pain not related to their knee joint
- •Patients with chronic opioid use (daily or almost daily use >3 months)
- •Patients with contraindications to dexamethasone (allergy, infection, Insulin dependent Diabetes Mellitus)
- •Patients with pre-existing neuropathy
- •Patients with hepatic failure
- •Patients with renal failure with eGFR<60
- •Patients with allergy to ketorolac or NSAIDs
研究组 & 干预措施
Adductor Canal block
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB.
干预措施: Adductor canal block (Drug)
Adductor Canal block
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB.
干预措施: Bupivacaine (Drug)
Adductor Canal block
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB.
干预措施: Fentanyl (Drug)
Adductor Canal block
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB.
干预措施: Ropivacaine 0.5% Injectable Solution (Drug)
Adductor canal block with dexamethasone
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB along with 8mg IV dexamethasone.
干预措施: Adductor canal block with dexamethasone (Drug)
Adductor canal block with dexamethasone
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB along with 8mg IV dexamethasone.
干预措施: Bupivacaine (Drug)
Adductor canal block with dexamethasone
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB along with 8mg IV dexamethasone.
干预措施: Fentanyl (Drug)
Adductor canal block with dexamethasone
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB along with 8mg IV dexamethasone.
干预措施: Ropivacaine 0.5% Injectable Solution (Drug)
Adductor canal block with dexamethasone
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB along with 8mg IV dexamethasone.
干预措施: Dexamethasone (Drug)
Adductor canal catheter
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their adductor canal block and have a catheter placed in the adductor canal at the mid-thigh. 0.2% ropivacaine at 5ml/hr will be run for 48 hours.
干预措施: Adductor canal catheter (Drug)
Adductor canal catheter
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their adductor canal block and have a catheter placed in the adductor canal at the mid-thigh. 0.2% ropivacaine at 5ml/hr will be run for 48 hours.
干预措施: Bupivacaine (Drug)
Adductor canal catheter
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their adductor canal block and have a catheter placed in the adductor canal at the mid-thigh. 0.2% ropivacaine at 5ml/hr will be run for 48 hours.
干预措施: Fentanyl (Drug)
Adductor canal catheter
Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their adductor canal block and have a catheter placed in the adductor canal at the mid-thigh. 0.2% ropivacaine at 5ml/hr will be run for 48 hours.
干预措施: Ropivacaine 0.5% Injectable Solution (Drug)
结局指标
主要结局
Cumulative 24 Hour Oral Morphine Equivalent Consumption
时间窗: 24 hours (Day 1)
Post-operative analgesia at 24 hours
次要结局
- Cumulative 12 Hour Oral Morphine Equivalent Consumption(12 hours (Day 0))
- Length of Stay(From surgical date until hospital discharge, up to 3 weeks)
- Incidence of Participants With Nausea/Vomiting Requiring Anti-emetics(0 to 48 hours)
- Time to First Use of PCA(0 to 48 hours)
- Cumulative 48 Hour Oral Morphine Equivalent Consumption(48 hours (Day 2))
- Pain Score(12, 24 and 48 hours)
- Quality of Recovery (QoR-40)(48 hours (Day 2))
研究者
Steven Lee
Principal Investigator
University of British Columbia