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临床试验/NCT05289427
NCT05289427已完成不适用

Triple Injection Peri-sartorius (TIPS) Block for Postoperative Analgesia After Total Knee Arthroplasty (TKA): Randomised Controlled Study

Alexandria University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Visual Analogue scale (resting and dynamic, 11 point scale from 0 - 10 where 0 accounts for no pain and 10 accounts for worst pain)

研究概览

简要总结

Comparison between the pain scores after total knee arthroplasty in patients receiving triple injection peri-sartorius (TIPS) block versus femoral nerve block (FNB)

详细描述

Introduction: Adequate pain control, along with quadriceps muscle preservation, has become a goal among orthopedic departments following TKA(1). The femoral nerve block (FNB) has been for many years the gold standard analgesic therapy for TKA however, it leads to quadriceps weakness(2).

Subsartorial block has been originally prescribed to block sensation in the front and the medial aspect of the knee with little quadriceps weakness (3). Local anaesthetic (LA) injected at the distal third of the adductor canal may enter into the popliteal region along with the femoral vessels to involve the popliteal plexus which supplies the posterior knee joint capsule (4). The anterior femoral cutaneous nerve (AFCN) is the overall term for the intermediate femoral cutaneous nerves (IFCNs) and the medial femoral cutaneous nerve (MFCN). The MFCN innervates the distal medial thigh as well as the anteromedial knee region. It may be anesthetized in the proximal part of the femoral triangle. The IFCN innervates the distal anterior thigh, which includes the proximal part of the surgical incision for TKA. They can be ultrasonographically identified and targeted in the subcutaneous plane on the anterior thigh where they pierce the fascia lata (FL) anterior to the sartorius muscle (SAM) before they ramify in multiple branches(5).

We hypothesize that injection of LA at the femoral triangle level above and below the sartorius muscle and at the distal end of the adductor canal may provide superior analgesia to femoral nerve block alone with little quadriceps weakness in TKA.

Aim of the study: The primary aim of this study is to compare the visual analogue scale scores during the 1st 24 postoperative hours after total knee arthroplasty in patients receiving triple injection peri-sartorius (TIPS) block versus FNB.

The secondary aims of this study are to compare the total postoperative opioid (morphine) consumption, evaluate the effect of the two techniques on the motor power of the operated limb and to detect any complications related to the block or opioids used.

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

  • American Society of Anesthesiologists (ASA) physical status I-III 80 patients scheduled for unilateral total knee arthroplasty -

排除标准

  • BMI > 35 kg/m2, Pre-existing neurological deficit, Any disability of the non-operated limb preventing fair mobilization, Known contraindications to peripheral nerve block (coagulopathy or infection at the site of injection), Chronic opioid users/abusers

结局指标

主要结局

Visual Analogue scale (resting and dynamic, 11 point scale from 0 - 10 where 0 accounts for no pain and 10 accounts for worst pain)

时间窗: 24 hours postoperatively

Compare the two groups regarding the visual analogue scale scores

次要结局

  • Operated limb motor power(24 hours postoperatively)
  • Total postoperative morphine consumption(24 hours postoperatively)
  • Complications(24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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