Adductor Canal Block in an Enhanced Recovery Program After Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Change in postoperative pain score at rest and knee flexion: Numerical Rating Scale
研究概览
简要总结
The purpose of this study is to assess the effectivity of adductor canal block performed the day after total knee arthroplasty surgery in reducing pain and improving walking ambulation ability and muscle strength.
详细描述
Overview: total knee arthroplasty is a painful procedure. According to our institutional pain registers the worst pain appears in postoperative day one, which could be related to the use of effective but short analgesic intraoperative techniques like periarticular local analgesic infiltration and intravenous multimodal analgesia.
The aim: to asses if adductor canal block performed the day after primary total knee arthroplasty (16-20 hours postoperative) improves analgesia without motor blockade and impairment of early ambulation ability.
Primary Hypothesis: adductor canal block performed 16-20 hours after primary total knee arthroplasty improves postoperative analgesia.
Secondary Hypothesis: adductor canal block performed 16-20 hours after primary total knee arthroplasty improves ability of early ambulation, adductor and quadriceps strength after primary total knee arthroplasty.
The objectives:
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)
盲法说明
All patients included in the study are transferred the day after the total knee arthroplasty surgery to the postoperative resuscitation unit.
A sterile dressing of the lower extremity is performed and after the adductor canal is identified with ultrasound image, a medial leg puncture is done with or without doing the canal adductor block. At the end all patients have a sterile apposite on the puncture site.
All variables and outcomes are collected and registered by people not involved in the realization of the intervention.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective unilateral total knee arthroplasty
- •American Society of Anesthesiologist (ASA) class 1-3
- •Adults aged 18-85 years old
排除标准
- •Contraindications of the adductor canal block.
- •Contraindications of the local infiltration analgesia technique.
- •Chronic kidney disease
- •Surgery to be performed under general anesthesia.
- •Opioid treatment > 30 mgr morphine or equivalent for more than 3 months time.
- •Neuropathic ipsilateral pain.
- •Inability to understand study procedures.
- •Not acceptance of the procedure (adductor canal block or local infiltration analgesia).
结局指标
主要结局
Change in postoperative pain score at rest and knee flexion: Numerical Rating Scale
时间窗: Registered immediately prior to surgery, first postoperative day immediately prior to procedure, 2 hours postprocedure and every 8 hours the first three days in the orthopedic ward.
Assessed using a Numerical Rating Scale (NRS) from 0 to 10
次要结局
- Adductor muscle strength(Immediately prior to surgery, first postoperative day immediately before the intervention , 2 and 24 hours postintervention)
- Rate of opioid side effects.(First 72 hours following surgery)
- Rate of adductor canal block complications(First 72 hours following surgery)
- Ability to walk with ten meter walk test(First and second postoperative day every 12 hours)
- Rate of medical complications(From date to operation until the data of discharge home, assessed up to 1 month)
- Knee extensor muscle strength(Immediately prior to surgery, first postoperative day immediately before the intervention , 2 and 24 hours postintervention)
- Rate of pain rescue treatments.(First 72 hours following surgery)
- Length of hospital stay(From date to operation until the data of discharge home, assessed up to 1 month)
- Rate of surgery local complications(From date to operation until the data of discharge home, assessed up to 1 month)
研究者
Reis Drudis
Principal Investigator
Institut de Recerca Biomèdica de Lleida