Selective Blocks for Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 75
- 主要终点
- Dynamic pain (pain upon movement) quantified as area-under-the-curve (AUC) 24-hours post-operatively
研究概览
简要总结
The investigators aimed to evaluate the efficacy of selective low volume ultrasound-guided blockades of the saphenous and obturator nerves on dynamic and rest pain 24-hours post-operatively for patients undergoing unilateral primary total knee arthroplasty.
详细描述
A femoral nerve block is the recommended strategy in many surgical centers to supplement multimodal analgesic regime following total knee arthroplasty (TKA) (i.e. both for spinal and general anesthesia). However, a femoral nerve block will often result in quadriceps paralysis, and this will increase the risk for the patient to fall as long as the femoral block have effect. Thus, the search for sensory nerve blocks to stop pain after TKA is a very interesting topic. The saphenous nerve is a purely sensory nerve, and the posterior branch of the obturator nerve is a mixed nerve, where the motor component only affects part of the adductor major muscle.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists' physical classification I-III
- •Age ≥ 18 years undergoing primary unilateral total knee arthroplasty
排除标准
- •Inability to cooperate
- •Inability to speak and understand Danish
- •Allergy to any drugs used in the study
- •Drug or alcohol abuse
- •Pregnancy or nursing
- •Opioid abusers
研究组 & 干预措施
Saphenous and obturator nerve block
5 ml of ropivacaine 0.75% for the saphenous nerve and 10 ml of ropivacaine 0,75% for the obturator nerve block.
Ropivacaine 0.75% for nerve blockades for both nerves mentioned.
干预措施: nerve block with ropivacaine (Drug)
Saphenous nerve block
5 ml of ropivacaine 0.75% for the saphenous nerve and 10 ml of isotonic saline for the obturator nerve block.
Ropivacaine 0.75% for the saphenous nerve block and saline for the obturator nerve block
干预措施: nerve block with ropivacaine and with saline (Drug)
Placebo nerve block
5 ml of isotonic saline for the saphenous nerve and 10 ml of isotonic saline for the obturator nerve block.
Saline for nerve blockades for both nerves mentioned.
干预措施: nerve block with saline (Drug)
结局指标
主要结局
Dynamic pain (pain upon movement) quantified as area-under-the-curve (AUC) 24-hours post-operatively
时间窗: 24 hours
NRS 0-10
次要结局
- Pain at rest quantified as area-under-the-curve (AUC) 24-hours post-operatively(24 hours)
- Length of stay in recovery and hospital(72 hours)
- Time to first mobilization(24 hours)
- Total opioid consumption(24 hours)
- Number of clinical complications(72 hours)
- Nausea and vomiting(24 hours)
研究者
Jens Borglum Neimann
Ass professor, PhD
Bispebjerg Hospital