Continuous Femoral Nerve Block Versus Local-wound Infiltration Analgesia For Patients Receiving Unilateral Total Knee Arthroplasty --- A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- chronic moderate-to-severe post-surgical pain
研究概览
简要总结
Post-operative pain after total knee arthroplasty is usually severe and impair the functional recovery of operated joints.The purpose of this study is to determine whether post-operative continuous femoral nerve block analgesia is superior to local wound infiltration combined with intravenous patient controlled analgesia in improving joint function and reducing the incidence of chronic post-surgical pain (CPSP).
详细描述
Major surgical types for knee included arthroscopy, total or partial knee arthroplastic surgery. These procedures are typically associated with severe pain. Function training, which is imperative after surgery for these patients, also aggravated pain.Post-operative pain after major knee surgery impaired post-operative knee recovery and prolonged inpatient length of stay.To maximize the efficacy and minimize the side effects of different options,a multi-modal analgesic regimen was recommended for patients underwent knee surgeries.Local wound infiltration and nerve block are given considerable attentions.Compared with systematic analgesia,nerve block with local anesthetics has been revealed to provide superior analgesia and better recovery of joint function compared with systemic analgesics. Currently,systematic evidence is sparse related to the comparative efficacy of pain control between local wound infiltration and nerve block,the investigators therefore conduct this randomized controlled trials.
This study was approved by the institutional review board of the First Affiliated Hospital of Chongqing Medical University. The protocol design is in accordance with Consolidated Standards of Reporting Trials (CONSORT) statement . This study is designed as a randomized controlled trial to compare the analgesic efficacy of continuous femoral nerve block (group CFNB) with local wound infiltration (group LWI).
Participants in group CFNB will receive a single injection for femoral nerve block intra-operatively combined with continuous femoral nerve block post-operatively guided by ultrasound and nerve stimulator.
Participants in group LWI will receive a peri-articular injection of suspension (48 ml of 0.8% ropivacaine with 2 ml of 40mg methylprednisolone) combined with intravenous non-opioid patient controlled analgesia.All participants will receive unified post-operative rehabilitation programme and the prophylaxis of infection and thrombo-embolism.
The primary outcome of this study is the incidence of chronic moderate-to-severe post-surgical pain.The secondary outcomes of this study are acute post-operative pain and rescue medication;knee function measured by WOMAC knee scores ;life ability measured by EQ-5D questionnaire;adverse events associated with the post-operative analgesia.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men and women over the 18 years and younger than 75 years old who had received selective unilateral knee replacement.
排除标准
- •bilateral knee replacement
- •the secondary knee revision and knee surgery not interfering with articular joint cavity (wound debridement and suture)
- •American Society of Anesthesiology (ASA) classification of anesthesia risk IV and V grade; body mass index higher than 35
- •coagulation dysfunction, which is assessed by activated partial thromboplastin time (APTT) higher than the upper limit by 10s
- •prothrombin time (PT) higher than the upper limit by 5s
- •International Normalized Ratio (INR) higher than 1.3, or any of criteria met above
- •local infection of puncture sites
- •neurological diseases
- •uncontrolled general infection
- •intra-operative cardiac arrest.
结局指标
主要结局
chronic moderate-to-severe post-surgical pain
时间窗: 3 months post-operatively
chronic moderate-to-severe post-surgical pain will be measured as more than 3 by numerical rating scale for pain
次要结局
- Analgesic Rescue(Post-operative day 1 to 3)
- Life Quality(3 months ,6 months and 12 months post-operatively)
- acute pain post-operatively(Post-operative day 1 to 3)
- Knee function(3 months ,6 months and 12 months post-operatively)
- Adverse events associated with post-operative analgesia(From surgey to discharge of hospital)
研究者
Min Su
The Department of Anesthesia and Pain Medicine
First Affiliated Hospital of Chongqing Medical University