2025-523071-34-00招募中4 期
Adductor canal and IPACK (infiltration between the popliteal artery and the capsule of the knee) blocks versus genicular nerves block for total knee arthroplasty: A randomized clinical trial
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2026年2月6日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- The Numerical Rating Scale (NRS) for pain.
研究概览
简要总结
Compare the analgesic efficacy between Geniculate Nerve Blocks versus the combination of IPACK (infiltration between the popliteal artery and the capsule of the knee) and Adductor Canal Blocks in patients undergoing primary total knee replacement (TKR). This will be evaluated during the first physiotherapy session at 24 hours postoperatively, using the Numerical Rating Scale (NRS) for pain assessment.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing primary total knee arthroplasty who provide consent to participate in the study and whose attending surgeon also agrees to the study.
- •ASA physical status classification I-III.
- •BMI 18-40 kg/m2.
排除标准
- •Patients who refuse to undergo the block procedure, who refuse to give their consent, or who are unable to cooperate with protocol compliance.
- •Patients in whom the total dose of local anesthetic exceeds the calculated toxic dose based on their ideal body weight.
- •Patients requiring general anesthesia.
- •Age younger than 18 years or older than 90 years.
- •Patients undergoing bilateral arthroplasty, revision arthroplasties, or prosthetic replacements.
- •Contraindication for peripheral nerve block (local infection, neurological deficit, complex regional pain syndrome, previous trauma, or surgery on the ipsilateral knee).
- •Systemic infection.
- •Consumption of opioids during the last 4 weeks at doses greater than 30 mg of oral morphine or equivalent.
- •Patients with a hemorrhagic diathesis or coagulopathy (diagnosed by medical history or laboratory tests).
- •Patients with allergies to any medication that is part of the protocol (e.g., allergy to local anesthetics).
结局指标
主要结局
The Numerical Rating Scale (NRS) for pain.
The Numerical Rating Scale (NRS) for pain.
次要结局
- Opioid consumption measured in morphine equivalents in milligrams.
- Range mobility measured by active and passive Range of Motion (ROM) Assessment.
- Quality of recovery 15 (QoR 15 questionnare).
- Evaluate NRS at 0, 12 and 48h postoperatively.
研究者
Clinical Trials Unit
Scientific
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
研究点 (1)
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