NCT06746168招募中不适用
Infiltration of Local Anesthetics Between the Popliteal Artery and Capsule of the Knee (iPACK) with Femoral Triangle Block (TFB) Versus Surgical Local Infiltration Analgesia (LIA) in Unilateral Total Knee Arthroplasty (TKA): a Multicenter Double-blind, Prospective Randomized Controlled Study.
Jessa Hospital2 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2025年1月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Numerical Rating Scale (NRS) pain score at mobilization at 8 hour postoperatively
研究概览
简要总结
The goal of this study is to compare the anesthetic combination iPACK with femoral triangle block versus surgical LIA for unilateral TKA. We hypothesize that an iPACK block with femoral triangle block is non-inferior to surgical LIA. Furthermore, due to visualization of the relevant neural and vascular structures, the risk of accidental popliteal block, nerve damage or LAST with (a blindly performed) LIA could theoretically be reduced.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- •ASA I-III
- •BMI 17-35 kg/m2
- •Patient is able to give informed consent
- •Patient is scheduled for TKA
排除标准
- •Refusal of patient
- •Inability to communicate due to language or neurologic barriers
- •Bilateral TKA or unilateral knee arthroplasty
- •Chronic opioid use (including partial opioid agonists) + chronic pain patients:
- •Use of atypical analgesics (gabapentin, pregabalin, ...)
- •History of Sudeck atrophy
- •History of >3 chronic pain consultations
- •Contraindications for spinal anesthesia
- •Patient refusal
- •Local infection
- •Aberrant coagulation (according to the latest ESRA guidelines)
- •Severe spinal canal stenosis
- •Intracranial hypertension
- •History of neurological injury in the affected limb
- •Contraindications for local anesthetics
- •Allergy for local anesthetics
- •Absolute contraindications for NSAIDs or paracetamol
- •Proven allergy for NSAID's (including ASA syndrome) or paracetamol
- •Severe renal function impairment (eGFR <30 ml/min/1.73 m2)
- •Active or recent (<6 months) history of gastric ulcera/perforations/bleeding
- •Crohn disease or colitis ulcerosa
- •Liver function impairment or severe renal function impairment (eGFR <30 ml/min/1.73 m2)
- •Pregnancy or breast-feeding
结局指标
主要结局
Numerical Rating Scale (NRS) pain score at mobilization at 8 hour postoperatively
时间窗: 8 hours postoperatively
The NRS pain score will be determined immediately after mobilizing patients from the bed to their seat at 8 hour postoperatively
次要结局
- NRS pain at movement for the first 24 hours(24 hours postoperatively)
- NRS pain at rest for the first 24 hours(24 hours postoperatively)
- Rate of popliteal block 8 hours after surgery(8 hours postoperatively)
- Functional recovery: timed up and go test(Baseline, 24 hours and 48 hours after surgery)
- Functional recovery: 30-second sit-to-stand-chair test(Baseline, 24 hours and 48 hours after surgery)
- Quality of Life: Short-form 36 (SF-36) questionnaire(Baseline, 3 months, 6 months)
- Quality of Life: WOMAC questionnaire(Baseline, 3 months, 6 months)
- Incidence of rescue blocks(8 to 12 hours after the spinal anesthesia)
- Need for rescue analgesia(during hospital stay, an average of 3 days)
- Time to be fit for discharge(during hospital stay, an average of 3 days)
研究者
Stessel Björn
MD, PhD
Jessa Hospital
研究点 (2)
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