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临床试验/NCT07130552
NCT07130552招募中不适用

Comparison of Distal IPACK and Popliteal Plexus Block Combined With Femoral Triangle Block After Total Knee Arthroplasty

Karaman Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年12月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
Opioid consumption

研究概览

简要总结

This study aims to investigate the effect of femoral triangle block combined with popliteal plexus block and distal IPACK block on postoperative pain after total knee arthroplasty (TKA)

详细描述

Popliteal Plexus Block (PPB) is a new nerve block technique that has been shown to anaesthetise nerves involved in the innervation of the posterior part of the knee joint.

The IPACK (interspace between the popliteal artery and capsule of the posterior knee) block is a regional anesthesia technique in which a local anesthetic is infiltrated under ultrasound guidance between the popliteal artery and the capsule of the posterior knee. This technique blocks the branches of the obturator nerve, the common peroneal nerve, and the tibial nerve in the popliteal region. In the context of knee arthroplasty, the application of the IPACK block has been associated with lower scores for ambulatory pain, lower scores for resting pain, and reduced morphine consumption.

Although both techniques of blockade seem to be efficient in the context of analgesia for the posterior part of the knee after TKA. No study compares these two blocks as part of multimodal analgesia to provide pain relief after TKA.

This study aimed to evaluate the analgesic effect of PPB or distal IPACK, in addition to femoral triangle block, as a component of a multimodal analgesic regimen after TKA.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients undergoing total knee arthroplasty under spinal anesthesia
  • •American Society of Anesthesiologists (ASA) status I-III
  • •Patients who give informed consent

排除标准

  • •Patients unable to cooperate
  • •Kidney disease with GFR < 50 ml/min
  • •Daily opioid consumption > 1 month
  • •Allergy to local anesthetics
  • •Neurological problems of the lower extremity
  • •Contraindications to peripheral nerve blocks

研究组 & 干预措施

Group Popliteal plexus block

Experimental

femoral triangle block and popliteal plexus block

干预措施: femoral triangle block and popliteal plexus block (Device)

Group distal iPACK

Experimental

Femoral triangle block and distal iPACK

干预措施: Femoral triangle block and distal iPACK (Device)

结局指标

主要结局

Opioid consumption

时间窗: 24 hours

Total opioid consumption in each group, A, B until 24 hours postoperative.

次要结局

  • Post-block MVIC by ankle plantarflexion, calculated as a percentage of the Pre-block baseline value(A 60-minute interval is between pre-block and post-block MVIC assessments)
  • Post-block MVIC by ankle dorsiflexion, calculated as a percentage of the Pre-block baseline value(A 60 minutes interval is between pre-block and post-block MVIC assessments)
  • Muscle strength of knee extension, graded by Manual Muscle Test (MMT)(Assessed pre-block, post-block (60 minutes after pre-block), and postoperative 5 hours)
  • NRS scores(48 hours)
  • Range of knee motion(48 hours)
  • Post-block Maximum Voluntary Isometric Contraction (MVIC) by knee extension, calculated as a percentage of the Pre-block baseline value(A 60-minute interval is between pre-block and post-block MVIC assessments)
  • Incidence of rebound pain(Postoperative 24 hours)
  • Quality of Recovery 15 Score(Postoperative Day 1)
  • Patient mobilization(48 hours)
  • Muscle strength of ankle plantarflexion, graded by MMT(Assessed pre-block, post-block (60 minutes after pre-block) and postoperative 5 hours)
  • Muscle strength of ankle dorsiflexion, graded by MMT(Assessed pre-block, post-block (60 minutes after pre-block) and postoperative 5 hours)

研究者

发起方
Karaman Training and Research Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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