Effect of Adductor Canal Blockade vs Femoral Nerve Blockade on Muscle Strength, Mobility and Pain in Patients With Severe Pain After Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change i muscle strength of the quadriceps muscle, after the blockade
研究概览
简要总结
The purpose of the study is to compare the effect of a Adductor Canal Blockade (ACB) vs a Femoral Nerve Blockade (FNB), on muscle strength, mobility and pain in patients with severe pain (VAS pain score > 60) after Total Knee Arthroplasty (TKA.
详细描述
The patients will be included after surgery (the first 2 postoperative days). Patients reporting VAS > 60 during active flexion of the knee can be included. All included patients will receive 2 blockades at the same time - an ACB and a FNB, one blockade with 30ml ropivacaine 0,2% and the other with 30ml saline according to randomization.
Prior to, and after, the blockades VAS pain scores will be obtained, muscle strength (quadriceps and adductors) will be measured using a handheld dynanometer and a Timed Up and Go test will be performed.
The study is registered at clinicaltrials.gov after inclusion of the first patient. The reason for this is that we recently became aware of that some journals do not accept a EudraCT registration. The study was registered at EudraCT (2012-004554-28)prior to enrollment of patients.
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
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •TKA within 72 hours and VAS>60 during 45 degrees active flexion of the knee despite conventional pain medication
- •informed consent
- •BMI 18-40
排除标准
- •Unable to communicate in Danish
- •Allergic reactions toward ropivacaine
- •Alcohol and or drug abuse
- •Unable to cooperate
- •Known sensory disturbances in the lower limbs
研究组 & 干预措施
Active FNB, placebo ACB
FNB with 30 ml of ropivacaine 0,2% and ACB with 30 ml of placebo (saline). The ACB will be performed just prior to the FNB. The blockades will be performed just after obtaining the baseline values (outcome measures) at time 0.
干预措施: Ropivacaine (Drug)
Active FNB, placebo ACB
FNB with 30 ml of ropivacaine 0,2% and ACB with 30 ml of placebo (saline). The ACB will be performed just prior to the FNB. The blockades will be performed just after obtaining the baseline values (outcome measures) at time 0.
干预措施: Placebo (Drug)
Active ACB, placebo FNB
ACB with 30 ml of ropivacaine 0,2% and FNB with 30 ml of placebo (saline.The ACB will be performed just prior to the FNB. The blockades will be performed just after obtaining the baseline values (outcome measures) at time 0.
干预措施: Ropivacaine (Drug)
Active ACB, placebo FNB
ACB with 30 ml of ropivacaine 0,2% and FNB with 30 ml of placebo (saline.The ACB will be performed just prior to the FNB. The blockades will be performed just after obtaining the baseline values (outcome measures) at time 0.
干预措施: Placebo (Drug)
结局指标
主要结局
Change i muscle strength of the quadriceps muscle, after the blockade
时间窗: 0 and 120 minutes
Maximum Voluntary Isometric Contraction (MVIC) of the quadriceps femoris muscle will be measured before and 2 hours after the blockade. The change will be compared between the groups. At each measuring point three measurements will be made and the average of these used.
次要结局
- muscle strength, adductor muscles(0 and 120 minutes)
- Timed Up and Go (TUG)test(0 and 120 minutes)
- VAS pain scores at rest(0 and 120 minutes)
- Pain during passive flexion of the knee(0 and 120 minutes)
研究者
Ulrik Grevstad
Consultant
University Hospital, Gentofte, Copenhagen