Liposomal Bupivacaine vs Perineural Adjuvants in Adductor Canal and iPACK Blocks in Patients Undergoing Primary Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Pain Score with Movement
研究概览
简要总结
The purpose of this research study is to compare two different combinations of anesthetic medications to see which works the best in providing the longest lasting pain relief for total knee arthroplasty surgery. The drugs being used are liposomal bupivacaine compared to a combination of bupivacaine, clonidine, epinephrine, buprenorphine, and dexamethasone. Pain scores will be collected at different intervals during study participation.
详细描述
This double-blinded prospective randomized control trial will evaluate analgesia following total knee arthroplasty for patients who receive an adductor canal block and infiltration between the popliteal artery and condyles of the knee (iPACK) block utilizing bupivacaine with the adjuvants clonidine, epinephrine, buprenorphine and dexamethasone (BPV-CEBD), as compared to patients who receive liposomal bupivacaine (LB) for both blocks.
All patients will receive a spinal anesthetic with ropivacaine (17.5 mg) and fentanyl (10 mcg), and an adductor canal and iPACK block for analgesia. Patients randomized to the LB group will receive 10 ml of 0.25% bupivacaine expanded with 133 mg (10 ml volume) of LB into both the adductor canal and iPACK blocks (total of 40 ml). The BPV-CEBD group will receive a 20 ml of solution consisting of 0.25% bupivacaine, 1.667mcg/ml of clonidine, 1:400,000 epinephrine, 0.15 mg total of buprenorphine, and 2 mg total of preservative free dexamethasone - which will be used in both the adductor canal block and iPACK block (total of 40 ml).
On post-operative day (POD) 0, rest and movement pain scores will be collected at 4 hours and 8 hours with time "zero" being the time of the final block placement. On POD 1 and 2, questionnaires will be collected for pain scores at 0700, 1200 and 1700. Participants will be called once daily on days 3 through 7 to collect remaining secondary data, including sleep score, quality of recovery, worst daily pain score, and patient satisfaction (POD 7 only).
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)
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
- •18-80 years of age
- •Receiving primary total knee arthroplasty
- •Patients receiving a spinal anesthetic with ropivacaine and fentanyl
- •American Society of Anesthesiology (ASA) category 1 to 3
排除标准
- •Revision of Total Knee Arthroplasty
- •Opioid use in the prior 6 months > 40 mg oxycodone equivalents per day or long-acting opioids as determined by the Prescription Drug Monitoring Program (PDMP)
- •Patients planned to receive general anesthesia
- •Patients planned to receive a spinal other than ropivacaine
- •History of peripheral neuropathy
- •Poorly controlled diabetes (Hgb A1C >8)
- •Allergies or contraindications to study medications: acetaminophen, celecoxib (including sulfa), methocarbamol, midazolam, fentanyl, bupivacaine, dexamethasone, acetaminophen, buprenorphine, NSAIDs, clonidine, epinephrine, and liposomal bupivacaine.
- •Unable to provide informed consent
研究组 & 干预措施
Liposomal Bupivacaine
randomized to liposomal bupivacaine in the adductor canal and infiltration between the popliteal artery and condyles of the knee (iPACK) block
干预措施: Liposomal Bupivacaine (Drug)
Bupivacaine, Clonidine, Epinephrine, Buprenorphine and Dexamethasone (BPV-CEBD)
randomized to bupivacaine mixed with clonidine, epinephrine, buprenorphine and dexamethasone in the adductor canal and infiltration between the popliteal artery and condyles of the knee (iPACK) block
干预措施: Bupivacaine, Clonidine, Epinephrine, Buprenorphine and Dexamethasone (BPV-CEBD) Combination (Drug)
结局指标
主要结局
Pain Score with Movement
时间窗: Hour 8 post final block placement
numerical rating scale pain score with movement utilizing the numerical rating pain score scale of 0 to 10, where 0 is no pain and 10 is the worst imaginable pain
Pain Score with Movement
时间窗: Baseline
numerical rating scale pain score with movement utilizing the numerical rating pain score scale of 0 to 10, where 0 is no pain and 10 is the worst imaginable pain
Pain Score with Movement
时间窗: Hour 4 post final block placement
numerical rating scale pain score with movement utilizing the numerical rating pain score scale of 0 to 10, where 0 is no pain and 10 is the worst imaginable pain
次要结局
- Pain Score with Rest(Hour 72 post final block placement)
- Pain Score with Movement(Hour 72 post final block placement)
- Highest Daily Pain Score(Postop Days 3, 4, 5, 6, 7)
- Cumulative Opioid Consumption(Hour 72 post final block placement)
- Quality of Recovery-15 Patient Survey(Postop Days 3, 4, 5, 6, 7)
- Distance Walked(24 hours)
- PROMIS Sleep Disturbance Survey(Postop Days 3, 4, 5, 6, 7)
- Patient Satisfaction(Postop Day 7)
- Incidence of Postoperative Nausea(Up to Postop Day 7)
- Incidence of Postoperative Vomiting(Up to Postop Day 7)
- Distance Walked(24 hours)
- Pain Score with Rest(Hour 72 post final block placement)
- Pain Score with Movement(Hour 72 post final block placement)
- Highest Daily Pain Score(Postop Days 3, 4, 5, 6, 7)
- Cumulative Opioid Consumption(Hour 72 post final block placement)
- Quality of Recovery-15 Patient Survey(Postop Days 3, 4, 5, 6, 7)
- PROMIS Sleep Disturbance Survey(Postop Days 3, 4, 5, 6, 7)
- Incidence of Postoperative Nausea(Up to Postop Day 7)
- Incidence of Postoperative Vomiting(Up to Postop Day 7)
- Pain Score with Rest(Hour 48 post final block placement)
- Cumulative Opioid Consumption(Hour 48 post final block placement)