Prospective, Randomized Controlled Trial Comparing Analgesic Efficacy of Single Injection vs. Continuous Interscalene Blockade vs. Local Infiltration Analgesia for Patients Undergoing Primary Total Shoulder Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Comparing Pain Intensity and Opioid-Related Adverse Effects Using Overall Benefit of Analgesia Score (OBAS).
研究概览
简要总结
Total shoulder arthroplasty (TSA) is considered to be a major surgical procedure resulting in severe postoperative pain, especially in the first 48 hours after surgery. The use of interscalene brachial plexus nerve block remains the cornerstone for analgesia following shoulder surgery; however, with the advent of local infiltration analgesia (LIA), there has been increasing interest in its use for total joint arthroplasty.
Since the benefits of local infiltration analgesia within a comprehensive multi-modal analgesia clinical pathway have yet to be established for total shoulder arthroplasty, the Investigators plan to assess and compare analgesia outcomes between three intervention groups: single shot interscalene brachial plexus block (SISB), continuous interscalene brachial plexus block (CISB), and local infiltration analgesia (LIA).
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
- 未提供
排除标准
- •Chronic pain syndromes such as fibromyalgia or complex regional pain syndrome
- •Chronic opioid use (>1 mos) with oral morphine equivalents (OME) >5 mg/day OR acute opioid use (< 1 mos) with OME > 30 mg/day.
- •Body mass index (BMI) > 45 kg/m2
- •Severe drug allergy* to medications used in this study, including non-steroidal anti-inflammatory drugs (i.e. celecoxib and ketorolac), and local anesthetics.
- •History of Malignant Hyperthermia.
- •Major systemic medical problems such as:
- •Pre-existing severe renal disorder defined as glomerular filtration rate (GFR) <50 units/m2 (if labs are available), currently on dialysis, or highly suspected based on history.
- •Severe hepatic disorder defined as current or past diagnosis of acute/subacute necrosis of liver, acute hepatic failure, chronic liver disease, cirrhosis (primary biliary cirrhosis), chronic hepatitis/toxic hepatitis, liver abscess, hepatic coma, hepatorenal syndrome, other disorders of liver
- •Pre-existing medical history of moderate to severe pulmonary disease (obstructive and/or restrictive), use of home oxygen, preoperative baseline oxygen saturation < 94% on room air, forced expiratory volume in 1 second (FEV 1) < 60% of predicted value (obstructive disease), vital capacity (VC) or total lung capacity (TLC) < 70% predicted value (restrictive disease).37
- •History of contralateral hemidiaphragmatic dysfunction (e.g., paralysis) or phrenic nerve injury.
- •Contraindication to a regional anesthesia technique (e.g., preexisting neuropathy+ in the operative extremity, coagulopathy, sepsis, infection at site of injection, uncooperative, refusal, anticoagulation medications not held within appropriate time frame per American Society of Regional Anesthesia (ASRA) guidelines.
- •Previous contralateral total shoulder replacement managed with regional anesthetic nerve block or periarticular injection/intraarticular injection within the previous 12 months.
- •Known to be currently pregnant or actively breastfeeding++
- •++ Patients that have a previous history of menopause, hysterectomy, or tubal ligation will not be required to perform a pregnancy test.
- •Impaired cognition
研究组 & 干预措施
Single shot interscalene nerve block
An interscalene nerve block will be performed under continuous live ultrasound guidance, obtaining visualization of the roots or trunks of the brachial plexus in between the anterior and middle scalene muscles. 15 to 20 mL of Bupivacaine 0.5% with 1:200,000 Epinephrine will be administered.
干预措施: Single shot interscalene nerve block (Drug)
Continuous interscalene nerve block
An interscalene nerve block and delivery of a catheter will be performed under continuous live ultrasound guidance, obtaining visualization of the roots or trunks of the brachial plexus in between the anterior and middle scalene muscles.
Initial loading bolus includes 15 to 20 mL of Bupivacaine 0.5% with 1:200,000 Epinephrine. After surgery, the continuous interscalene nerve block catheter will be loaded in the post-anesthesia care unit (PACU) with bupivacaine 0.2% 10 milliliters (mL), and then an infusion will be initiated of bupivacaine 0.2% at 8 to 10 mL per hour.
干预措施: Continuous interscalene nerve block (Drug)
Local Infiltration Analgesia (LIA)
The LIA group will utilize weight based dosing of Ropivacaine as part of a "cocktail" solution containing ropivacaine, epinephrine, ketorolac, and normal saline 0.9%. Patients will receive a total volume of 120 mL injected strategically in the periarticular structures by the surgeon. This is a one-time injection. This will occur after implantation of the final prostheses, but prior to closure of the fascia.
干预措施: Local Infiltration Analgesia (LIA) (Drug)
结局指标
主要结局
Comparing Pain Intensity and Opioid-Related Adverse Effects Using Overall Benefit of Analgesia Score (OBAS).
时间窗: Post-Operative Day 1
The OBAS score was calculated using the sum of the scores from six questions. OBAS ranges from 0 (best) to 28 (worst), where a low score indicates a high benefit to the subjects.
次要结局
未报告次要终点
研究者
Jason K. Panchamia, D.O.
Instructor in Anesthesiology
Mayo Clinic