Comparison of the Benefit of Peripheral Nerve Quadri-block Versus Adductor Canal Block + Surgical Infiltration in Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Patient's recovery at H24 as after surgery assessed by the QoR-15 (Quality of Recovery) questionnaire score
研究概览
简要总结
The aim of this study is to evaluate the analgesic efficacy of this quadruple sensory block compared with the currently recommended procedure (adductor canal block + infiltration).
详细描述
In addition to the adductor canal block, this quadruple block incorporates :
- the block of the lateral cutaneous nerve of the thigh (or femoral-cutaneous nerve), which is a collateral sensory branch of the posterior part of the lumbar plexus.
- IPACK (Infiltration between Popliteal Artery and Capsule of Knee), designed as a motor-sparing technique (targeting the sensory articular branches of the sciatic nerve and avoiding the motor branches of the tibial and fibular nerves), is particularly effective on posterior pain.
- obturator nerve block, a mixed nerve originating from the anterior part of the lumbar plexus. It divides into two branches: anterior, which innervates the adductor longus, adductor brevis and gracilis muscles, and posterior, which innervates the medial part of the knee joint and the posteromedial part of the thigh. It provides sensitivity to the medial aspect of the thigh.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, 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
- 否
入选标准
- •Adult male or female
- •Patient with signed consent to participate in the study,
- •Patient with uni or bilateral primary gonarthrosis
- •Indication for total knee arthroplasty.
排除标准
- •History of knee fracture, arthroplasty or osteotomy
- •Known or unknown contraindication to ALR or locoregional anesthesia products
- •Neurological disease, stroke sequelae
- •Mental deficiency or any other reason that may hinder understanding or strict application of the protocol
- •Patient not affiliated to the French social security system
- •Patient under court protection, guardianship or curatorship
- •Pregnant or potentially pregnant women (women of childbearing age without effective contraception)
- •Patient already included in another therapeutic study protocol
研究组 & 干预措施
Group 1 of local analgesia protocol (PROSPECT recommandations)
Locoregional analgesia (LRA) protocol n°1 : adductor canal block + surgical infiltration (PROSPECT recommendations)
干预措施: Analgesia (Procedure)
Group 2 of local analgesia protocol (quadri-peripheral nerve block )
Locoregional analgesia (LRA) protocol n° 2 : adductor canal block + femoral-cutaneous block + obturator block + IPACK block
干预措施: Analgesia (Procedure)
结局指标
主要结局
Patient's recovery at H24 as after surgery assessed by the QoR-15 (Quality of Recovery) questionnaire score
时间窗: From enrollement to the last H24 after surgery
The QoR-15 score at H24 after surgery was compared between the two groups for primary endpoint analysis. The QoR-15 accurately measures postoperative recovery by focusing on 5 key domains: pain, physical comfort, physical independence, psychological support and emotional state. Each item is rated from 0 (unfavorable) to 10 (favorable), with an overall score corresponding to the sum of the score obtained for each item, i.e. a score from 0 (no recovery) to 150 (full recovery).
次要结局
- Knee functional assessment(Hour 0)
- Post operative pain(Hour 2)
- Post operative pain(Hour 6)
- Post operative pain(Hour 12)
- First ambulation(Hour 12)
- Post operative pain(Hour 24)
- Joint range of both knees(Hour 24)
- First ambulation(Hour 24)
- Post operative pain(Hour 48)
- Joint range of both knees(Hour 48)
- First ambulation(Hour 48)
- Joint range of both knees(Month 1)
- Drug tolerance(Month 1)
- Knee functional assessment(Month 1)
- Opioid drug use(Hour 48)
- Return to patient usual activities(Month 1)
- Post operative pain(Month 1)
- Length of stay in the post-intervention monitoring room(Hour 48)
- Length of hospitalisation(Month 1)
- Quality of recovery(Hour 48)
- Non-opioid drug use(Hour 48)
- Patient comfort(Hour 1)