Local Infiltration Analgesia Vs. Interscalene Block in Total Shoulder Arthorplasty: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Pain visual analog scale (VAS)
研究概览
简要总结
Pain management following total shoulder arthroplasty is an important factor in determining patient outcomes and satisfaction. Interscalene brachial plexus blockade has been used successfully to minimize pain in the acute post-operative period. While shown to be effective, interscalene blockade has known complications. In addition, interscalene block has been shown to be significantly more expensive when compared to local anesthesia infiltration.
Local anesthetics such as bupivacaine have long been used to assist in post-operative anesthesia. Recent reports have demonstrated local infiltration of liposomal bupivacaine to be similar to interscalene block in regards to patient analgesia even in the first 24 hours post operatively, with the added benefit of lower complications and costs. While most reports examine the efficacy of local infiltration with liposomal bupivacaine in the shoulder, other total joint literature has been positive regarding the use of local infiltration analgesic mixture for improved post-operative analgesia using a multi-modal approach to infiltrative analgesia. Despite these reports, the role and efficacy of local infiltration analgesia in shoulder arthroplasty is lacking. The purpose of the proposed study is to determine the efficacy and safety of local infiltration analgesia in shoulder arthroplasty in comparison to interscalene block through a randomized prospective clinical trial. Our hypothesis is that local infiltration analgesia will lead to postoperative pain scores, opiate consumption, and complication rate that are not significantly different from interscalene block.
详细描述
- SELECTION OF SUBJECTS • Inclusion Criteria: Adult patients (18 years of age or greater) undergoing primary anatomic or reverse total shoulder arthroplasty secondary to osteoarthritis, cuff tear arthropathy, or massive irreparable rotator cuff tear.
• Exclusion Criteria :
- Narcotic dependent
- Previous ipsilateral open shoulder surgery
- Chronic pain syndromes (fibromyalgia)
- Contraindication to regional anesthesia
- Cervical radiculopathy
- Unable to give consent; Prisoner
- Workers compensation insurance
- Mentally Disabled.
- Pregnant Patients
- STUDY PROCEDURE • Timeline: 2 weeks of data collection
• Study subjects: Study candidates will be identified as they present to the clinic at the Missouri Orthopaedic Institute at the University of Missouri, and will be evaluated by the principle investigator. Informed consent will be obtained as per IRB protocol. Enrollees will receive a copy of the study protocol, consent, and HIPAA form. Background patient information will be collected including age, sex, BMI and co-morbidities. American Society of Anesthesiologist (ASA) classification will be assigned by the involved anesthesiologist.
Interscalene regional block is routinely administered at our institution prior to total shoulder arthroplasty. Patients will be randomized prior to their scheduled surgery date by our research team using a randomization protocol developed by our department biostatistics team. The surgeon and surgical assistants will be blinded about the group assignment until the morning of the surgery day. The group assignment will be sealed in an envelope and delivered to the surgeon. If randomized to the interscalene block group, the anesthesia team will administer the block preoperatively in routine fashion. The standard anesthesia protocol for total shoulder arthroplasty patients is as follows:
• Preoperative: Acetaminophen 1000mg PO Gabapentin 300mg PO Interscalene block: 3-5mL of 0.5% bupivacaine plus 10mL Exparel (1-2 mg of midazolam and/or 50-100 mcg of fentanyl IV for sedation)
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
- Single (Outcomes Assessor)
盲法说明
Patients will be randomized prior to their scheduled surgery date by our research team using a randomization protocol developed by our department biostatistics team. The surgeons and anesthesiologists will be blinded about the group assignment until the day before surgery. The group assignment will be sealed in an envelope and delivered to the surgeon.
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
- •Adult patients (18 years of age or greater)
- •Primary anatomic or reverse total shoulder arthroplasty secondary to osteoarthritis, cuff tear arthropathy, or massive irreparable rotator cuff tear
排除标准
- •Narcotic dependent
- •Previous ipsilateral open shoulder surgery
- •Chronic pain syndromes (fibromyalgia)
- •Contraindication to regional anesthesia
- •Cervical radiculopathy
- •Workers compensation insurance
- •Mentally Disabled.
- •Pregnant Patients
结局指标
主要结局
Pain visual analog scale (VAS)
时间窗: From 4 hours to 14 days postop
Following surgery, the patient's pain level will be recorded in a visual analog scale (VAS) at 4 hours, 8 hours, 12 hours, 24 hours, 2 days and daily until 7 days, and then at 14 days.
Opiate consumption
时间窗: From postop day 1 to 2 weeks
The patient's daily opiate consumption during the first 7 days following surgery and the toal accumulated amount of opiate consumption by 2 weeks postop will also be recorded, quantified and converted to morphine equivalents units (MEU) for standardization
次要结局
- Intraoperative complications(Intraoperative)
- Length of surgical procedure(Intraoperative)
- Length of hospital stay(for postoperative 1 week)
- Postoperative complications(for postoperative 3 months)
研究者
H. Mike Kim
ASSOCIATE PROFESSOR OF CLINICAL ORTHOPAEDIC SURGERY
University of Missouri-Columbia