Analgesic Efficacy of Different Liposomal Bupivacaine Doses in the Adductor Canal Block for Total Knee Arthroplasty: a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 177
- 试验地点
- 1
- 主要终点
- Weighted area under curve (AUC) pain score
研究概览
简要总结
Total knee arthroplasty is a commonly performed orthopaedic surgery for the treatment of end-stage osteoarthritis when conservative management becomes ineffective. TKA is associated with significant acute postoperative pain and many patients experience severe postoperative pain despite the use of multimodal analgesia. Poor acute postoperative pain control impacts rehabilitation, prolongs recovery and increases opioid consumption and chronic post-surgical pain.
Liposomal bupivacaine (Exparel, Pacira Pharmaceuticals Inc, Parsippany, New Jersey, USA) is a multivesicular formulation of bupivacaine that prolongs drug release and can extend the duration of analgesia. The adductor canal block (ACB) has been shown to reduce pain intensity and opioid consumption after total knee arthroplasty. The use of liposomal bupivacaine in the adductor canal block has recently been FDA-approved. However, the results of its efficacy from existing clinical trials have been mixed. In addition, the doses in the clinical trials have been different, and the optimal dose for perineural application of liposomal bupivacaine is unclear, including for the adductor canal block.
In this project, the investigators propose to conduct a randomized controlled trial to investigate the effect of different doses of liposomal bupivacaine in the adductor canal block on acute postoperative pain intensity and opioid consumption after robotic assisted total knee arthroplasty. The investigators will also assess secondary outcomes including knee functional scores, chronic pain and quality of recovery.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I-III
- •Age 18-80 years old
- •Scheduled for elective primary unilateral total knee arthroplasty (TKA) with robotic surgery
- •Able to speak and understand Cantonese or Mandarin or English
- •Able to provide informed oral and written consent
排除标准
- •Revision TKA
- •Single-stage bilateral TKA
- •Complex primary TKA requiring use of stem/augment/constrained liner
- •Surgeries with significant intraoperative complications which may alter rehabilitation protocol eg collateral ligament injury, fracture requiring fixation
- •Known allergy to opioids, local anaesthetic drugs, paracetamol, non-steroidal anti-inflammatory drugs (NSAIDS) including COX-2 inhibitors
- •History of chronic pain other than chronic knee pain
- •History of immunosuppression
- •Chronic use of glucocorticoids
- •Chronic opioid use (morphine, fentanyl, hydromorphone, ketobemidone, methadone, nicomorphine, oxycodone, or meperidine)
- •History of congestive heart failure (NYHA 2)
- •Alcohol or drug abuse
- •Impaired renal function (defined as effective glomerular filtration rate < 30ml/min/1.73m2
- •Impaired liver function (defined as plasma bilirubin over 34mol/L; international normalized ratio [INR] >= 1.7, alanine aminotransferase [ALT] over 100U/L, aspartate aminotransferase [AST] over 100U/L)
- •Coagulopathy (platelet count <100,000/ml and/or INR >= 1.5) or the use of anticoagulants (not including aspirin) that precludes the use of adductor canal blocks
- •Pre-existing neurological or muscular disorders
- •Psychiatric illness
- •Impaired mental state
- •Pregnancy
- •Local infection
- •On immunosuppressants
- •High body mass index (BMI) (>=40)
- •Patient refusal for regional nerve blocks or to conduct clinical trial
研究组 & 干预措施
ACB using 20ml 0.5% standard bupivacaine (SB-ACB)
adductor canal block with 20ml 0.5% standard bupivacaine only
干预措施: 0.5% standard bupivacaine only (Drug)
ACB using 10ml 1.33% liposomal bupivacaine with 10 ml 0.5% standard bupivacaine (LB10-ACB)
adductor canal block with 10ml 1.33% liposomal bupivacaine (133mg) plus 10ml 0.5% standard bupivacaine
干预措施: 1.33% liposomal bupivacaine with 0.5% standard bupivacaine (Drug)
ACB using 20ml 1.33% liposomal bupivacaine only (LB20-ACB)
adductor canal block with 20ml 1.33% liposomal bupivacaine (266mg)
干预措施: 1.33% liposomal bupivacaine only (Drug)
结局指标
主要结局
Weighted area under curve (AUC) pain score
时间窗: The first 48 hours after surgery when the patient is at rest
Pain severity would be rated at rest after surgery using numerical rating scale (NRS) with 0 to 10 where 0=no pain and 10=the worst possible pain
次要结局
- Oxynorm consumption(Postoperative day 1-7)
- NRS pain scores(from after surgery to postoperative day 7)
- Overall Benefit of Analgesic Score (OBAS)(Postoperative day (POD) 1-7)
- Plasma level of bupivacaine and ropivacaine(Blood will be collected during induction, at 12 hours, 24 hours, 48 hours, and 72 hours after ACB.)
- Quality of Recovery Questionnaire (QoR-9)(Postoperative day 1)
- Rehabilitation parameters (Duration of hospital stay)(estimated on average of postoperative day 7 at the date of discharge from hospital)
- Rehabilitation parameters (discharge location)(estimated on average of postoperative day 7 at the date of discharge from hospital)
- Opioid-related side effects(While the patient is in hospital from postoperative day 0, 1, and 2.)
- Potential side effects related to adductor canal block (ACB)(While the patient is in hospital from postoperative day 0, 1, and 2.)
- Rehabilitation parameters (range of maximal active knee flexion)(While the patient is in hospital from postoperative day 0, day 1, and day 2.)
- Rehabilitation parameters (quadricep power)(While the patient is in hospital from postoperative day 0, day 1, and day 2.)
- Rehabilitation parameters (ability to perform straight leg raising)(While the patient is in hospital from postoperative day 0, day 1, and day 2.)
- Rehabilitation parameters (walking distance)(While the patient is in hospital from postoperative day 0, day 1, and day 2.)
- Analgesic block duration(While the patient is in hospital at postoperative day 1)
- Sensory and motor assessment(While the patient is in hospital from post-block 2 hours, 6 hours, 12 hours, and 24 hours.)
- quality of life (SF12v2)(at 6 weeks and at 3 and 6 months after surgery)
- Identification Pain Questionnaire for Neuropathic Pain (ID-NeP)(at 6 weeks, 3 months and 6 months postoperatively)
- Knee Society Knee Function Score(at 6 weeks, 3 months and 6 months postoperatively)
- Chronic post-surgical pain(at 6 weeks, 3 months and 6 months postoperatively)
研究者
Wong Sau Ching Stanley
Clinical Associate Professor
The University of Hong Kong