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临床试验/NCT06630520
NCT06630520已完成不适用

Intraoperative Periarticular Injection May Improve Postoperative Pain Scores and Reduce Opioid Consumption in Arthroscopic Anterior Cruciate Ligament Reconstruction Surgery

Taipei Veterans General Hospital, Taiwan2 个研究点 分布在 1 个国家目标入组 288 人开始时间: 2022年3月20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
288
试验地点
2
主要终点
VAS scores

研究概览

简要总结

In this prospective, assessor-blinded, single-surgeon clinical trial, the goal was to validate the efficacy of PAI in aACLR surgery with a reduced opioid dose, while achieving similar pain relief with few adverse events. 300 patients who had undergone aACLR were randomly allocated to receive either a PAI or nPAI group. The primary outcome parameters were visual analogue scale (VAS) scores and cumulative morphine dose, through time. Secondary outcome parameters included drug-related adverse events.

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

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

入选标准

  • Patients 18 years or older who had undergone a-ACLR with or without meniscus procedure for anterolateral instability of the knee; 2) agree to participate in this study and to be randomly allocated to either or peri-articular injection protocol and have signed an informed consent.

排除标准

  • patients with other concomitant injuries such as other ligamentous injury or fracture; 2) Allergy to any of the medication used in either protocol; 3) patient with history of the chronic pain 4) preoperative chronic opioid-dependent patients (exceeding 50 mg oral morphine equivalence per day at time of recruitment); 5) refuse to participate in this study.

结局指标

主要结局

VAS scores

时间窗: at different time points (postoperative 4,8,24-hour, before discharge) after surgery

次要结局

  • cumulative morphine consumption (mg)(at post-operative 4, 8, 24-hour and before discharge)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

En-Rung Chiang

Division Director

Taipei Veterans General Hospital, Taiwan

研究点 (2)

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