Continuous Infusion Pump Versus Single Shot Peripheral Block for Pain Management After Same-day Orthopaedic Surgery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 80
研究概览
简要总结
This study will be a pragmatic, prospective cluster randomized trial, where clusters will formed based on sequential 2 week time increments across the study recruitment period.. Patients 18 years or older undergoing ACL reconstruction, open shoulder labrum or rotator cuff surgery, arthroscopic rotator cuff repair, proximal or distal patellar realignment surgery, open knee arthrotomy cases (i.e. inside out meniscus repair, osteochondral allograft transplantation (OCA), meniscal allograft transplantation (MAT)) at University Center for Ambulatory Surgery, LLC (UOA) will be reviewed for eligibility. Once identified, potential study subjects will be asked whether they are interested in participating in the project. If the patient agrees, the subject will be given the informed consent to read and sign.
Objectives: The primary objective is to compare the effectiveness of postoperative infusion pain pump versus preoperative nerve block in reducing visual analog pain scores/numerical pain rating scale (VAS/NPRS) in the postoperative period. The second objective is to evaluate the requirement of narcotic and non-narcotic analgesic medications between the two groups.
Hypotheses: Use of continuous infusion pain pump or single shot peripheral block will result in similar post-operative pain control after outpatient sports medicine surgical cases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- •Age 18 years or older
- •ACL reconstruction
- •Open shoulder labrum or rotator cuff surgery
- •Arthroscopic rotator cuff repair
- •Proximal or distal patellar realignment surgery
- •Open knee arthrotomy cases - Inside out meniscus repair, OCA, MAT
排除标准
- •Age under 18 years
- •Body mass index of greater than 40 kg/m2
- •American Society of Anesthesiologist class 4 physical status or greater
- •History of drug or alcohol abuse
- •Chronic opioid use/pain management doctor
- •Allergy to bupivacaine, ropivacaine or pharmacologic analogs
- •Any coagulation disorders
- •Existing nerve injury
- •Severe bronchopulmonary disease
- •Pregnant patients
研究者
Charles Gatt, MD
Chair of the Department of Orthopaedic Surgery at Rutgers Robert Wood Johnson
Rutgers, The State University of New Jersey
