Determining the Efficacy of Intravenous Acetaminophen as a Non-Narcotic Postoperative Pain Management Technique Following Knee Arthroscopy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AdventHealth
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Postoperative Pain Levels
研究概览
简要总结
The purpose of this randomized, placebo controlled, single blind study is to determine if postoperative pain levels, as measured by a verbal numeric pain rating scale (VNRS), are reduced with the administration of IV acetaminophen when compared to a control group. Particular focus will be on the postoperative opioid consumption. In addition, we will ascertain if the total time the participant is in the PACU differs in those who receive the IV acetaminophen versus those who do not.
详细描述
This is a randomized, placebo controlled, single blind study of intravenous (IV) acetaminophen in a postoperative arthroscopy patient population. Although use of this medication as a non-narcotic analgesia has been validated in other patient populations such as post operative pelvic and abdominal surgeries, it has not been demonstrated in those who have recently undergone knee arthroscopy with or without chondroplasty. In this study all participants will be injected with a standard of care intra-articular dose of ropivacaine HCl, .2% (Naropin) prior to transfer to the Post Anesthesia Care Unit (PACU). Each will be randomized 1:1 to receive IV acetaminophen in 100ml of 0.9% NS (treatment group) or a 100 ml 0.9 % NS placebo (control).
The PACU nursing staff will periodically ascertain the participants' pain scores on a 0-10 scale. All other pain medication or related treatment will be recorded. Statistical analysis will be done to determine if there is a difference in pain scores between the treatment versus control group. Further evaluation will examine if opioid consumption and total time in PACU differs between groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is scheduled for knee arthroscopy with or without chondroplasty.
- •Scheduled arthroscopy procedure will not include ligament repairs or ligament reconstructions and/or bone cutting or fixation procedures.
- •Has not received any acetaminophen (IV, PR, PO) within at least 8 hours of the initiation of surgery.
- •Is willing and able to sign an informed consent.
排除标准
- •Is undergoing arthroscopy for ligament repairs/reconstructions and bone cutting or fixation procedures
- •Has self-reported and/or documented previous hypersensitivity to acetaminophen.
- •Has self-reported and/or documented history of hepatic disease or impairment.
- •Pre-operative calculated creatinine clearance (CrCL) less than 40 ml/min.
- •Has a medical history of alcohol abuse and/or currently drinks more than 3 alcoholic beverages per day.
- •Has a medical history of substance dependence (i.e. prescription analgesics or illegal drugs such as cocaine, heroin, etc...). May be self-reported or maybe per the judgment of the physician PI/Sub-I.
研究组 & 干预措施
Intravenous acetaminophen
Infusion of Intravenous acetaminophen (Ofirmev)
干预措施: Intravenous Acetaminophen (Drug)
Placebo (0.9% Normal Saline Infusion)
Infusion of 100 ml of 0.9 NS Normal Saline
干预措施: Placebo (0.9% Normal Saline infusion) (Drug)
结局指标
主要结局
Postoperative Pain Levels
时间窗: up to 8 hours
To determine if postoperative pain levels, as measured by a Verbal Numerical Rating Scale (VNRS), are reduced with the administration of IV acetaminophen when compared to a control group. In the VNRS, the user has the option to verbally rate their scale from 0 to 10. Zero indicates the absence of pain, while 10 represents the most intense pain possible.
次要结局
- Postoperative Opioid Consumption(up to 8 hours)