跳至主要内容
临床试验/NCT06086483
NCT06086483已完成4 期

Pain Management and Functional Recovery After Adductor Canal Block Combined With iPACK Block for Total Knee Arthroplasty. A Prospective, Randomized, Double-blinded Clinical Trial.

Poznan University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 361 人开始时间: 2020年6月18日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
361
试验地点
1
主要终点
postoperative Numeric Pain Rating Scale

研究概览

简要总结

This randomized, double-blinded, placebo-controlled trial sought to evaluate the efficacy of the iPACK block with Adductor Canal Block on postoperative pain, functional recovery and NLR and PLR levels.

详细描述

The Interspace between the popliteal artery and capsule of the posterior knee, or iPACK block, together with the Adductor Canal block (ACB), has been described and shows promise in providing analgesia to the knee joint. However, the effect of these two blocks on postoperative pain levels, functional recovery, and stress response is uncertain. This study compares a preoperative iPACK and ACB block to Sham blocks before total knee arthroplasty under spinal anesthesia.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients > 18 years old undergoing unilateral total knee arthroplasty

排除标准

  • refusal to participate
  • Chronic opioid use
  • localized infection

研究组 & 干预措施

iPACK block+ABC block

Active Comparator

Patients received a preoperative ultrasound-guided iPACK block with 20 mL of 0.25% ropivacaine and an Adductor Canal block with 20mL 0.25% ropivacaine.

干预措施: Ropivacaine 0.2% Injectable Solution (Drug)

Sham blocks

Active Comparator

Patients received a preoperative ultrasound-guided iPACK block with 20 mL of 0.9% normal saline and an Adductor Canal block with 20mL 0.9% normal saline.

干预措施: 0.9%sodium chloride (Drug)

结局指标

主要结局

postoperative Numeric Pain Rating Scale

时间窗: 24 hours after surgery

Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

postoperative Numeric Pain Rating Scale during active flexion

时间窗: 96 hours after surgery

Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

postoperative Numeric Pain Rating Scale et rest

时间窗: 96 hours after surgery

Numeric Pain Rating Scale. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

次要结局

  • Postoperative opioid consumption(96 hours after surgery)
  • Neutrophil-to-lymphocyte ratio(24 hours after surgery)
  • Platelet-to-lymphocyte ratio(24 hours after surgery)
  • Time to first opioid administration(96 hours postoperatively)

研究者

发起方
Poznan University of Medical Sciences
申办方类型
Other
责任方
Sponsor

研究点 (1)

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