Effects of 10 Versus 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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Total opioid consumption, expressed in oral morphine milligram equivalents (MME).
研究概览
简要总结
This trial aims to assess the analgesic effect of Popliteal Plexus Block (PPB) with 10 mL versus 20 mL of Bupivacain 5 mg/mL, when applied as an adjunct treatment to a multimodal analgesic regimen following primary total knee arthroplasty. We hypothesize that PPB with 20 mL of local anesthetic reduces 24-hour postoperative opioid consumption (= primary outcome) compared to 10 mL after TKA.
Secondary outcome include
- the frequency of 24-hour opioid-free analgesia
- pain intensity at rest and during mobilization
- Manual Muscle Tests and ability to mobilize with crutches six hours after end-of-surgery
- and patients reported outcomes using the Quality of Recovery 15 survey 24 hours after end-of-surgery.
Participant will:
- undergo primary total knee arthroplasty in spinal anesthesia.
- recieve a PPB with either 10 mL of Bupivacaine or 20 mL.
- recieve a multimodal analgesic regime including a Femoral Triangle Block.
- Have 10 scored morphine tablets available for self-administration within the first 24 postoperative hours after end-of-surgery.
- be examined by a physiotherapist 6 hours (±1 hour) after end-of-surgery to assess pain scores, manual muscle testing of ankle and knee function, and the ability to mobilize with crutches.
- complete a survey 24 hours after end-of-surgery to assess self-administered morphine intake, pain scores, and Quality of Recovery-15.
详细描述
Patients will undergo primary unilateral total knee arthroplasty with insertion of non-cruciate retaining standard cemented prosthesis by a parapatellar medial approach, without use of tourniquet or Local Infiltration Analgesia.
For the spinal anesthesia, 3 mL of Ropivacaine 5 mg/ml will be applied.
All patients will receive a femoral triangle block in combination with the PPB, both administered immediately after surgery in the post-anesthesia care unit.
Description of the PPB procedure:
The superficial femoral artery is identified at mid-thigh level and traced caudally until it deviates from sartorius muscle and is positioned adjacent to the posteromedial margin of the vastus medialis muscle, close to the adductor hiatus. The needle will be inserted medially to the transducer and advanced in-plane through the sartorius muscle targeting the endpoint of injection in the distal part of the adductor canal, on the top of the superficial femoral artery, posteromedial to the fascia of the vastus medialis muscle. We will inject the allocated volume of bupivacaine 5 mg/mL, ensuring anterolaterally spread to the artery
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Good-Clinical-Practice monitor is also blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
研究组 & 干预措施
Popliteal Plexus Block with 20 mL of bupivacaine
干预措施: Bupivacaine (Drug)
Popliteal Plexus Block with 10 mL of bupivacaine
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Total opioid consumption, expressed in oral morphine milligram equivalents (MME).
时间窗: From T0 (end-of-surgery time) to T24 (24 hours after end-of-surgery time)
Combining hospital-administered opioid doses from the patient file and self-reported intake of dispensed morphine tablets.
次要结局
- No opioid requirement(From T0 (end-of-surgery time) to T24 (24 hours after end-of-surgery time))
- Pain at rest(Assessed preoperatively, at T6 (6±1 hours after end-of-surgery time), and at T24 (24 hours after end-of-surgery time).)
- Pain during 10 meters walk assisted only by crutches(Assessed preoperatively, at T6 (6±1 hours after end-of-surgery time), and at T24 (24 hours after end-of-surgery time).)
- Early postoperative walking ability(Assessed at T6 (6±1 end-of-surgery time))
- Quality of Recovery 15(Assessed at T24 (24 hours after end-of-surgery time))
- Postoperative Manual Muscle Test(Assessed at T6 (6±1 end-of-surgery time))
研究者
Johan Kløvgaard Sørensen
Principal Investigator
Regionshospitalet Silkeborg