ACL Repair and Multimodal Analgesia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Opioid Consumption in the Immediate Postoperative Period
研究概览
简要总结
This study will evaluate the effectiveness of an aggressive multimodal regimen versus standard multimodal for Anterior Cruciate Ligament (ACL) repair using hamstring graft for patients having surgery in our outpatient surgicenter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of orthopedic surgeons on the study team scheduled for ACL repair using hamstring graft from the same leg will be considered for inclusion in this study. Other inclusion criteria are as follows:
- •American Society of Anesthesiologists (ASA) physical status 1-3
- •BMI of < 40 kg/m2
- •Consents to general anesthesia and pre-operative femoral nerve block for case
排除标准
- •Any contraindication to a femoral nerve block
- •Allergy to local anesthetics, nonsteroidal anti-inflammatory medications, ketamine, acetaminophen, hydromorphone, oxycodone
- •Peripheral or central nervous system disease
- •Renal or hepatic impairment
- •History of opioid dependence or current regular narcotic use
- •Significant psychiatric disease
- •Pregnancy or lactation (by verbal report)
- •Seizure Disorder
- •History of post-operative nausea and vomiting
- •Latex allergy
- •Clinically significant cardiac or pulmonary disease
研究组 & 干预措施
placebo pills and injectables
standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane
干预措施: placebo pills and injectables (Drug)
结局指标
主要结局
Opioid Consumption in the Immediate Postoperative Period
时间窗: Up to 10 hours
This data will be entered into the participants electronic medical record and collected from their chart once the participant has been discharged. The "immediate postoperative period" covers the participant's entire time in the outpatient surgery center after they have entered the recovery room postoperatively. The amount of time they remain in the outpatient surgery center postoperatively varies from a minimum of 1 hour to a maximum of 10 hours and an average of 4 hours.
次要结局
- Post-Operative Incidence of Nausea(Up to 24 hours following surgery)
- Intraoperative Medication Use: Ketorolac and Lidocaine(From induction until arrival in post anesthesia care unit.)
- Number of Participants Who Received Medication for Nausea(Up to 24 hours following surgery)
- Post-Operative Nausea Scores(Up to 24 hours following surgery)
- Impact of Block Characteristics on Pain Control(Up to 24 hours following surgery)
- Number of Participants With Complications From the Procedure(Up to 24 hours following surgery)
- Time to Discharge(Up to 24 hours following surgery)
- Incidence of Post-Operative Pruritus(Up to 24 hours following surgery)
- Sedation Scale(Up to 24 hours following surgery)
- Pain Scores During Recovery(up to 24 hours postoperatively)
- Post-Operative Pruritis Score(Up to 24 hours following surgery)
- Intraoperative Medication Use: Fentanyl(From induction until arrival in post anesthesia care unit.)