Study of Peri-Articular Anaesthetic for Replacement of the Knee
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 533
- 试验地点
- 11
- 主要终点
- Quality of Recovery 40 (QoR-40)
研究概览
简要总结
The clinical and cost effectiveness of peri-articular liposomal bupivacaine plus bupivacaine hydrochloride compared with bupivacaine hydrochloride alone for post-operative recovery after knee replacement surgery: A multi-centre, patient-blinded, randomised controlled trial.
详细描述
The trial design is a patient-blinded multi-centre, active comparator, randomised controlled two-arm parallel group superiority trial of liposomal bupivacaine plus bupivacaine hydrochloride versus bupivacaine alone for post-operative pain in patients undergoing knee replacement surgery.
Patients will be randomised in a 1:1 ratio. The randomised controlled trial (RCT) design is robust and reduces any potential bias. Patients will be blinded as to which treatment they receive. Blinding of patients is possible as they will be under general anaesthetic for their knee replacement surgery at the time of the drug administration. Blinding of surgeons, who administer the medication and outcome assessors was not necessary as the primary outcome is a patient reported outcome measure.
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
- Single (Participant)
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
- •Unilateral primary knee replacement, including both total knee replacement (TKR) or unicompartmental knee replacement (UKR), for end stage osteoarthritis
- •American Society of Anaesthesiologists (ASA) Grade I to III
- •Participant is willing and able consent for themselves
- •Male or Female, aged 18 years or above
- •In the Investigator's opinion, is able and willing to comply with all trial requirements
排除标准
- •Allergy or intolerance to amide type local anaesthetics
- •Objective evidence of nerve damage in the affected lower limb.
- •Rheumatoid arthritis
- •Any other significant disease, disorder or condition which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the results of the trial, or the participant's ability to participate in the trial.
- •Participants who have participated in another research trial involving an investigational product in the past 6 months.
- •Participants who have significant cognitive impairment or language issues
- •Contra-lateral knee replacement within the trial or within 12 months prior to randomisation
研究组 & 干预措施
Liposomal bupivacaine (EXPAREL)
266mg/20ml EXPAREL mixed with 80ml 0.9% normal saline and 100mg/20ml 0.5% plain bupivacaine hydrochloride. Administered as a single dose intra-operatively by periarticular infiltration.
干预措施: Liposomal bupivacaine (Drug)
Liposomal bupivacaine (EXPAREL)
266mg/20ml EXPAREL mixed with 80ml 0.9% normal saline and 100mg/20ml 0.5% plain bupivacaine hydrochloride. Administered as a single dose intra-operatively by periarticular infiltration.
干预措施: Bupivacaine hydrochloride (Drug)
Bupivacaine hydrochloride alone
100ml 0.9% normal saline mixed with 100mg/20ml 0.5% plain bupivacaine hydrochloride.
Administered as a single dose intra-operatively by periarticular infiltration.
干预措施: Bupivacaine hydrochloride (Drug)
结局指标
主要结局
Quality of Recovery 40 (QoR-40)
时间窗: Change in score between 0, 24, 48 and 72 hours post-operatively
A 40-item instrument which encompass most aspects of a good quality of recovery after surgery. Consists of five clinically relevant dimensions: 1. Physical comfort (12 items) 2. Emotional state (9 items) 3. Physical independence (5 items) 4. Psychological support (7 items) 5. Pain (7 items). The QoR-40 has a possible score of 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).
Cumulative 0-10 pain Visual Analogue Score (VAS)
时间窗: Cumulative score at 0, 24, 48 and 72 hours post-operatively
Cumulative daily pain score at rest. A 10 point scale where 0 = no pain, 5 = moderate pain and 10 = worst possible pain.
次要结局
- Mean 0-10 pain Visual Analogue Score (VAS)(0, 24, 48 and 72 hours post-operatively)
- Opioid consumption(Change in consumption between 0, 24, 48 and 72 hours post-operatively)
- Oxford Knee Score (OKS)(Change in score between baseline, 72 hours, 6 weeks, 6 months, 1 year post-operatively)
- American Knee Society Score (AKSS)(Change in score between baseline, 72 hours, 6 weeks, 6 months, 1 year post-operatively)
- Health economics(Change in cost utility between baseline, 6 weeks, 6 months, 1 year post-operatively)
- Fitness for discharge (as per routine clinical care)(Assessed at 0, 24, 48 and 72 hours post-operatively)
- EuroQol 5 Dimension scale(Change in score between baseline, 72 hours, 6 weeks, 6 months, 1 year post-operatively)
- Serious Adverse Events (SAE)(Within 30 days of surgery)
研究者
Hemant Pandit
Professor
University of Leeds