2024-520204-26-00招募中4 期
Effects of 10 vs. 20 mL Local Anesthetic for Popliteal Plexus Block on Opioid Consumption, Pain, and Patient-Reported Outcomes after Total Knee Arthroplasty - a randomized, controlled, blinded study
Region Midtjylland1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年3月17日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Total opioid consumption from end-of-surgery time (T0) until 24 hours postoperatively (T24), expressed in oral morphine milligram equivalents (MME).
研究概览
简要总结
The aim of this study is to assess the analgesic effect of Popliteal Plexus Block (PPB) with 10 mL versus 20 mL of local anesthetic as an adjunct to Femoral Triangle Block in a multimodal analgesic regimen following primary unilateral total knee arthroplasty. We hypothesize that using 20 mL of local anesthetic for PPB instead of 10 mL will decrease 24-hour postoperative opioid consumption.
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
- •Age > 18 years
- •Scheduled to undergo primary total knee arthroplasty in spinal anesthesia.
- •Ability to give their written informed consent after having fully understood the contents of the study.
- •American Society of Anesthesiologists (ASA) physical status 1, 2, or 3.
排除标准
- •Patients who cannot read or speak Danish.
- •Patients who cannot operate or have access to a smartphone with internet connectivity (required for patient-reported outcome assessment).
- •Patients with allergies or intolerance to the medicines used in the study.
- •Patients with a consistent daily intake of opioids preoperatively.
- •Patients who are dependent on walking aid devices preoperatively.
- •Patients suffering from alcohol and/or drug abuse – based on the investigator's assessment.
- •Diagnosed with chronic neurodegenerative disorders.
结局指标
主要结局
Total opioid consumption from end-of-surgery time (T0) until 24 hours postoperatively (T24), expressed in oral morphine milligram equivalents (MME).
Total opioid consumption from end-of-surgery time (T0) until 24 hours postoperatively (T24), expressed in oral morphine milligram equivalents (MME).
次要结局
- Frequency of patients with no opioid consumption from T0 until T24.
- Pain in the operated knee at rest, scored by NRS, obtained at the timepoints: Preoperative, at 6 hours (+/- 1 hour) after end-of-surgery time (T6), and at T24.
- Pain in the operated knee during a 10-meter walk with crutches, scored by NRS, obtained at the time points: Preoperative, T6 and at T24.
- Frequency of patients unable to walk 10 meters with crutches at T6.
- Frequency of Manual Muscle Test results < Grade 3 in evaluations of dorsiflexion and plantarflexion of the ankle and knee extension, examined at T6.
- Patient reported outcome measure of Quality of Recovery 15 at T24.
研究者
Johan Kløvgaard Sørensen
Scientific
Region Midtjylland
研究点 (1)
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