Effect of Adductor Canal Block vs. Placebo on Muscle Strength, Mobilisation and Pain on the First Post-operative Day After Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Difference between groups in muscle strength of the quadriceps femoris muscle.
研究概览
简要总结
The purpose of this study is to evaluate the effect of adductor canal block (ACB) vs. placebo on muscle strength, mobility and pain on the first postoperative day after total knee alloplastic (TKA).
详细描述
Patients will be included on the first day after TKA surgery and randomized in two groups. Each group will receive 2 ACB with a 1 hour interval, one ACB with an active drug, Ropivacaine, and another ACB with a placebo drug, Saline.
At T0, arm ACB_active/placebo will receive the active ACB with Ropivacaine followed by the placebo ACB at T60 (60 minutes after T0).
At T0, arm ACB_placebo/active will receive the placebo ACB with Saline followed by the active ACB with Ropivacaine at T60 (60 minutes after T0).
Outcome measurements will be made at T60, 1 hour after the first ACB, and the difference in outcome between the groups will be compared.
Baseline values will be measured prior to the first ACB. Final measurements at T120 (120 minutes after the initial ACB), will determine if the differences between the groups are eliminated, since both groups then have received an active ACB.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have had a Total Knee Arthroplasty surgery within 2 days (1.postoperative day on inclusion)
- •Written informed consent.
排除标准
- •Non-cooperative patients
- •Patients who have already had a peripheral or central block post surgery.
- •Patients who are not able to perform a TUG test pre surgery.
- •Patients who do not understand or speak Danish.
- •Patient who are allergic to the drugs used in this research.
- •Patients with alcohol- or drug abuse - determined by investigator.
- •Patients with peripheral sensory neuropathy in their lower extremities.
- •Pregnant patients.
研究组 & 干预措施
ACB_active/placebo
Patients will receive the first ACB with a active drug, 30 ml bolus Ropivacaine 7,5 mg/ml at T0. First outcome measurement are made one hour after the first ACB, prior to their second ACB. At T60 (60 minutes after T0), patients will receive their second ACB with the placebo drug, 30 ml bolus Saline and outcome measures performed again at T120(120 minutes after T0).
The measurements for baseline and outcome will be made in following order:
VAS pain score at rest - VAS pain score during active flexion of the knee - Muscle strength - TUG test - Highest VAS pain score during TUG test
干预措施: Ropivacaine 7,5 mg/ml (Drug)
ACB_active/placebo
Patients will receive the first ACB with a active drug, 30 ml bolus Ropivacaine 7,5 mg/ml at T0. First outcome measurement are made one hour after the first ACB, prior to their second ACB. At T60 (60 minutes after T0), patients will receive their second ACB with the placebo drug, 30 ml bolus Saline and outcome measures performed again at T120(120 minutes after T0).
The measurements for baseline and outcome will be made in following order:
VAS pain score at rest - VAS pain score during active flexion of the knee - Muscle strength - TUG test - Highest VAS pain score during TUG test
干预措施: Saline (Drug)
ACB_placebo/active
Patients will receive the first ACB with placebo, 30 ml isotonic saline at T0. First outcome measurement are made one hour after the first ACB, prior to their second ACB. At T60(60 minutes after T0), patients will receive their second ACB with the ropivacaine 7,5 mg/ml 30 ml and outcome measures performed again at T120(120 minutes after T0).
The measurements for baseline and outcome will be made in following order:
VAS pain score at rest - VAS pain score during active flexion of the knee - Muscle strength - TUG test - Highest VAS pain score during TUG test
干预措施: Ropivacaine 7,5 mg/ml (Drug)
ACB_placebo/active
Patients will receive the first ACB with placebo, 30 ml isotonic saline at T0. First outcome measurement are made one hour after the first ACB, prior to their second ACB. At T60(60 minutes after T0), patients will receive their second ACB with the ropivacaine 7,5 mg/ml 30 ml and outcome measures performed again at T120(120 minutes after T0).
The measurements for baseline and outcome will be made in following order:
VAS pain score at rest - VAS pain score during active flexion of the knee - Muscle strength - TUG test - Highest VAS pain score during TUG test
干预措施: Saline (Drug)
结局指标
主要结局
Difference between groups in muscle strength of the quadriceps femoris muscle.
时间窗: 60 minutes after first ACB (T60)
Muscle strength is assessed as maximum voluntary isometric contraction (MVIC) using a hand-held dynamometer.3 consecutive measurements will be made and the average used. Results for each group will be presented as percentage of baseline values. The primary outcome is the difference in MVIC between the groups.
次要结局
- Difference between groups in muscle strength of the quadriceps femoris muscle.(120 minutes after initial ACB (T120))
- VAS pain scores at rest(60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120))
- VAS pain score during TUG test.(60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120)
- Timed Up and Go(TUG) test(60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120)
- VAS pain scores during 45 degrees active flexion of the knee(60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120)
- Sub-group analysis of muscle strength and mobility acconding to baseline VAS during active flexion of the knee prior to the first block(60 minutes after first ACB (T60))
研究者
Ulrik Grevstad
Consultant, MD
University Hospital, Gentofte, Copenhagen