An Observational Study of the Pharmacokinetics of Adductor Canal Block Using Liposomal Bupivacaine and Standard Bupivacaine in Total Knee Arthroplasty Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Time to peak concentration of serum bupivacaine
研究概览
简要总结
With the aging of the population, osteoarthritis of knees and hips become major orthopedic problems worldwide. Osteoarthritis of the knees and hips is associated with a significant pain problem and functional disability. Total joints replacement is the ultimate surgical procedure to deal with such problems. Multimodal analgesia, including periarticular local infiltration of analgesia (LIA), regional nerve block using adductor canal block (ACB), opioid and non-opioid have been shown to be effective in managing postoperative pain. Regional nerve block using femoral nerve block or adductor canal block (ACB) is also a well-established analgesic technique after total knee replacement. Standard bupivacaine (SB), levobupivacaine, ropivacaine were used in ACB in these studies. Whether combining ACB with periarticular LIA has the additional benefit of prolonging analgesia or with synergistic effect remains controversial, because the number of RCTs conducted is not enough. Liposomal bupivacaine (LB) may further prolong the analgesic effect of ACB, as the therapeutic levels of bupivacaine are below the toxic range and sustained for 72 hours after injection. The purpose of this study is to evaluate the safety and systemic levels of serum bupivacaine following adductor canal block using LB 66.5mg in patients undergoing TKA with LIA over a 72-hour period. This also serves as a pilot study to determine the dose and timing of blood taking for serum bupivacaine level of a previously IRB approved study - "Comparing the efficacy of combining periarticular local infiltration of analgesia and adductor canal block using liposomal bupivacaine and standard bupivacaine- A prospective randomized controlled trial".
详细描述
After signing the consent form, participants will receive LIA with ACB using 5ml of 1.33% liposomal bupivacaine with 5ml of 0.9% normal saline.
Participants will receive routine preoperative, intraoperative, and postoperative treatments like other patients undergoing total knee replacement.
Blood will be collected during induction, at 1 hour, 2 hours, 4 hours, 8 hours, and 12 hours after the performance of ACB through a designated 14-gauge cannula, and also at 24, 48, and 72 hours after the operation during routine blood taking.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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 replacement
- •Chinese patients
- •BMI < 40
- •Able to speak and understand Cantonese
- •Able to provide informed oral and written consent
排除标准
- •Single-stage bilateral total knee replacement
- •Complex primary total knee replacement requiring the use of stem/augment/constrained liner
- •Surgeries with significant intraoperative complications which may alter rehabilitation protocol e.g. 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
- •Daily use of glucocorticoids
- •Daily use of strong opioids (morphine, fentanyl, hydromorphone, ketobemidone, methadone, nicomorphine, oxycodone, or meperidine)
- •History of severe heart disease (NYHA 2)
- •Alcohol or drug abuse
- •Impaired renal function, defined as preoperative serum creatinine level over 120 micromol/L
- •Pre-existing neurological or muscular disorders
- •Psychiatric illness or neurologic or psychiatric diseases potentially influencing pain perception
- •Impaired or retarded mental state
- •Difficulties in using patient-controlled analgesia (PCA)
- •Pregnancy
- •Local infection
- •On immunosuppressants
- •High BMI (>=40)
- •Patient refusal
研究组 & 干预措施
liposomal bupivacaine
Nerve block will be preformed using 5ml of 1.33% liposomal bupivacaine with 5ml of 0.9% normal saline.
干预措施: Liposomal bupivacaine (Drug)
结局指标
主要结局
Time to peak concentration of serum bupivacaine
时间窗: 72 hours after the operation
Serum bupivacaine will be quantified using High Performance Liquid Chromatography.
次要结局
未报告次要终点
研究者
Dr. Chan Chi-Wing
Honorary Clinical Associate Professor
The University of Hong Kong
