Prospective, Randomized, Controlled Trial Comparing Continuous Femoral and Single Injection Sciatic Peripheral Nerve Blocks vs Periarticular Injection With Ropivacaine or Liposomal Bupivacaine (Exparel) on Patients Undergoing Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Maximum Pain Post-Operative Day (POD) 1 (Morning)
研究概览
简要总结
The purpose of this study is to find a better way to make patients comfortable after their knee surgery. The investigators compared three ways of providing pain relief, either by use of a nerve block at the femoral and sciatic nerve areas, or with actual injections in the surgical joint area with one of two different medicines, either ropivacaine or liposomal bupivacaine (Exparel®). The hypothesis was that the nerve block at the femoral and sciatic nerve areas would result in lower pain scores and opioid consumption than either of the two injections in the surgical joint area.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients with an American Society of Anesthesiologists (ASA) physiological status I-III
- •Patients presenting for unilateral primary total knee replacement.
- •No focal neurologic deficit of the surgical lower extremity.
- •Cognitively intact with the ability to sign informed consent
排除标准
- •Chronic pain syndromes such as fibromyalgia or complex regional pain syndrome
- •History of long term use of daily opioids (>1 months) with oral morphine equivalent (OME) >5mg/day.
- •Body mass index (BMI) > 40 kg/m2
- •Allergies to medications used in this study such as: fentanyl, hydromorphone, ketorolac, ibuprofen, acetaminophen, local anesthetics, oxycodone, OxyContin, tramadol, ondansetron, droperidol, or dexamethasone, celecoxib
- •Major systemic medical problems such as:
- •Severe renal disorder defined as glomerular filtration rate (GFR) <50 units/m2
- •Cardiovascular disorders defined as congestive heart failure (CHF) New York Heart Association (NYHA) class III-IV
- •Severe hepatic disorder defined as current or past diagnosis of acute/subacute necrosis liver, acute hepatic failure, chronic liver disease, cirrhosis (primary biliary cirrhosis), fatty liver, chronic hepatitis/toxic hepatitis, liver abscess, hepatic coma, hepatorenal syndrome, other disorders of liver.
- •Impaired cognitive function or inability to understand the study protocol
- •Contraindication to a regional anesthesia technique (e.g., preexisting neuropathy in the operative extremity, coagulopathy [platelets < 100,000, International Normalized Ratio (INR) >1.5], refusal, etc.).
- •Previous contralateral knee replacement managed with regional or periarticular injection
- •Unable to follow-up at the 3 month interval at Mayo Clinic in Rochester, Minnesota
- •Pregnancy or breast feeding (women of child-bearing potential, must have a negative pregnancy test)
研究组 & 干预措施
Peripheral Nerve Block (PNB)
This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
干预措施: Peripheral nerve blocks with Bupivacaine (Drug)
Ropivacaine (PAI-R)
This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
干预措施: Intra articular injection with Ropivacaine (Drug)
Liposomal Bupivacaine (PAI-L)
This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
干预措施: Intra articular injection with liposomal bupivacaine (Drug)
结局指标
主要结局
Maximum Pain Post-Operative Day (POD) 1 (Morning)
时间窗: Post-Operative Day 1, approximately 6 am to 12:00 pm
Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.
次要结局
- Maximum Pain Post-PACU(Post-operative Day 0, approximately 12 pm to 12 am)
- Maximum Pain POD 1 (24 Hours)(POD 1, approximately 12 am to 12 am next day)
- Average Pain POD 2 (24 Hours)(POD 2, approximately 12 am to 12 am next day)
- Preoperative Daily Opioid Use(baseline)
- Intraoperative Opioid Use(During the procedure, approximately 2 hours after start of the procedure)
- Maximum Pain POD 2 (24 Hours)(POD 2, approximately 12 am to 12 am next day)
- POD 0 Post-PACU Opioid Use(POD 0, approximately 12 pm to 12 am)
- Average Pain Post-Postanesthesia Care Unit (PACU)(Post-operative Day 0, approximately 12 pm to 12 am)
- Average Pain POD 1 (24 Hours)(POD 1, approximately 12 am to 12 am next day)
- Balance Testing on Operative Leg Using Unipedal Stance Time(baseline, approximately 12 weeks)
- PACU Opioid Use(Approximately 2 hours after entry in PACU)
- Hospital Length of Stay(Approximately 3 days)
- POD 1 Opioid Use(POD 1, approximately 12 am to 12 am next day)
- POD 2 Opioid Use(POD 2, approximately 12 am to 12 am next day)
研究者
Sandra (Sandy) L. Kopp, M.D.
Associate Professor of Anesthesiology
Mayo Clinic