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临床试验/NCT04295421
NCT04295421已完成不适用

Comparison of Adductor Canal Block and IPACK Block With Adductor Canal Block Alone After Total Knee Arthroplasty

University Tunis El Manar2 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2020年3月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
88
试验地点
2
主要终点
Morphine consumption

研究概览

简要总结

Adductor canal block (ACB) is a peripheral nerve blockade technique that provides good pain control in patients undergoing total knee arthroplasty (TKA) which however does not relieve posterior knee pain. The recent technique of an ultrasound-guided local anesthetic infiltration of the interspace between popliteal artery and the capsule of posterior knee (IPACK) has shown promising results in providing significant posterior knee analgesia without affecting the motor nerves. The hypothesis was that the combination of ACB + IPACK will provide better pain relief and improve knee function in the immediate postoperative period compared to ACB alone.

详细描述

This is a prospective, randomized and double blinded study

All patients received :

  • Pregabalin 150 mg preoperatively 12 h before the surgery.
  • Single-shot spinal anesthesia with 10 to 12 mg of bupivacaine 0.5% and 2.5ug sufentanil patients were randomly allocated to receive:
  • Group 1: IPACK + ACB single shoot
  • Group 2: contineous ACB For group 1: IPACK was realized after spinal anesthesia with 40 ml ropivacaine 0.2% All patients received ACB in the immediate postoperative period with 20 ml ropivacaine 0.2%

Post operative analgesia included:

  • Paracetamol 1g IV every 6 hours
  • Diclofenac sodium (50mg) 1 tablet x 2 per day
  • Pregabalin 150 mg given orally once daily for a period of 4 weeks.
  • PCA morphine (Patient Controlled Analgesia), as a rescue analgesia,
  • Continuous ACB catheter for 48H with :

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

性别
All
接受健康志愿者

入选标准

  • primary total knee arthroplasty under spinal anesthesia

排除标准

  • Contraindication or refusal to regional anesthesia
  • Contraindication to non steroidal anti inflammatory (NSAID's)
  • Allergy to opioids
  • Allergy to paracetamol
  • Creatinine clearance < 30ml/min
  • Weight<50 kg or >100kg

结局指标

主要结局

Morphine consumption

时间窗: Day 2

total Morphine consumption

次要结局

  • functional status(Month 6)
  • Pain score during mouvment(Day 2 [0=no pain ; 10=worste pain])
  • Chronic pain(Month 6)
  • Pain score at rest(Day 2)
  • Ambulation distance(Day 2)

研究者

发起方
University Tunis El Manar
申办方类型
Other
责任方
Principal Investigator
主要研究者

Olfa kaabachi, MD

Professor

University Tunis El Manar

研究点 (2)

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