Femoral Triangle and Adductor Canal Blocks Versus Femoral Nerve Block for Total Knee Arthroplasty: Postoperative Pain Management and Functional Recovery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Extent of Motor Blockade
研究概览
简要总结
This prospective, double-blinded, randomized controlled study evaluates effects of femoral triangle and adductor canal blocks in comparison with femoral nerve block for primary total knee arthroplasty. Patients undergoing primary total knee arthroplasty will be randomly assigned to receive either femoral triangle and adductor canal blocks or femoral nerve block. Comparison of these two groups of patients will be based on the effects on postoperative pain control, extent of motor blockade, ability of early ambulation, patients satisfaction rates over the time of clinical recovery and the length of hospitalization.
To the investigator's knowledge, no comparison has been made between femoral triangle and adductor canal blocks and femoral nerve block or any other block. Consequently, we hypothesized that femoral triangle and adductor canal blocks and femoral nerve block provide similar effects on postoperative pain control, but femoral triangle and adductor canal blocks are superior to femoral nerve block in terms of early postoperative mobilization.
详细描述
The aim: to evaluate femoral triangle and adductor canal blocks and femoral nerve block regarding the postoperative analgesic efficacy, extent of motor blockade, ability of early ambulation in patients following primary total knee arthroplasty.
Primary Hypothesis: femoral triangle and adductor canal blocks and femoral nerve block provide similar postoperative pain relieving effect after primary total knee arthroplasty.
Secondary Effects: femoral triangle and adductor canal blocks provide better ability of early ambulation after primary total knee arthroplasty.
The objectives:
- To compare postoperative pain control effects between femoral triangle and adductor canal blocks and femoral nerve block groups of patients after primary total knee joint replacement surgery.
- To assess the ability of early ambulation and extent of motor blockade after primary total knee joint replacement surgery between the groups of patients.
- To estimate opioid consumption and its adverse effects in femoral triangle and adductor canal blocks and femoral nerve block groups of patients after primary total knee arthroplasty.
- To compare patients postoperative satisfaction rates between femoral triangle and adductor canal blocks and femoral nerve block groups of patients after primary total knee arthroplasty.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing primary unilateral total knee arthroplasty under the spinal anesthesia.
- •Age 18 - 90 years.
- •Patients conformed to American Society of Anesthesiologists (ASA) physical status I-III in preoperative assessment.
- •Ability to follow the study protocol.
排除标准
- •Inability or refusal to follow the study protocol.
- •American Society of Anesthesiologists (ASA) physical status classification of IV or higher.
- •Coagulopathy.
- •Pre-existing lower extremity neuromuscular disorders.
- •Local infection over the injection site.
- •Allergy or contraindications to the drugs used in the study (local anesthetics, NSAIDs, opioids).
- •Chronic opioid use.
- •Other type of anesthesia.
结局指标
主要结局
Extent of Motor Blockade
时间窗: 3, 6, 24, 48 hours after primary total knee arthroplasty.
The extent of postoperative motor blockade will be evaluated using Bromage scale: Grade I - free movement of legs and feet, Grade II - just able to flex knees with free movement of feet, Grade III - unable to flex knees, but with free movement of feet, Grade IV - unable to move legs or feet. It will be assessed at 3, 6, 24, 48 hours after surgery.
Postoperative Pain Intensity and Pain Control
时间窗: 3, 6, 24, 48 hours after primary total knee arthroplasty.
Postoperative pain intensity and pain control will be assessed in both groups using visual analogue scale (VAS). VAS scale is consisted of a scale from 0 (no pain) to 10 (worst imaginable pain). Pain control and pain intensity will be assessed at rest, during active and passive 45 degree knee flexion at 3, 6, 24, 48 hours after surgery.
次要结局
- Rate of Patients Satisfaction(3, 6, 24, 48 hours after primary total knee arthroplasty.)
- Number of Participants With Nausea or Vomiting(3, 6, 24, 48 hours after primary total knee arthroplasty.)
- Ability of Early Ambulation After Surgery(24, 48 hours after primary total knee arthroplasty.)
- Number of Participants Needing Additional Opioids(3, 6, 24, 48 hours after primary total knee arthroplasty.)
研究者
Inna Jaremko
Principal Investigator
Lithuanian University of Health Sciences