Decreased Opioid Consumption and Enhance Recovery With the Addition of IV-Acetaminophen in Colorectal Patients: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 主要终点
- Total opioid consumption
研究概览
简要总结
The investigators hypothesis is that use of IV acetaminophen will significantly decrease use of post-operative opioid consumption and enhances recovery after colorectal surgery.
详细描述
All patients undergoing laparoscopic and open colorectal surgery are randomized to receive either IV acetaminophen or placebo. All patients received an opioid patient controlled anesthesia (PCA). IV acetaminophen (1 gram) or placebo is given 30 minutes prior to operation and every 6 hours thereafter for up to 5 days post-operatively or discharge.
The investigators primary endpoint is to evaluate opioid consumption during the patient's hospital stay. The investigators secondary endpoints are to evaluate return of gastrointestinal function (ROGIF), time to diet ordered (TTDO), length of hospital stay (LOHS) and occurrence of ileus. Pain is measured with the pain visual analog scale score (PVASS) at 3, 8, 24 and 48 hours.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient undergoing colorectal operation (Hartmann's procedure, sigmoidectomy, left hemicolectomy, right hemicolectomy, transverse colectomy, ileocecectomy, colo-colonic anastomosis, colorectal anastomosis, ileo-colonic anastomosis, low anterior resection, or abdominoperineal resection)
- •Age range from 18 to 90 years old
- •Patient providing signed, written informed consent before participation in the study
排除标准
- •Patient younger than 18 years old or older than 90 years old
- •Patient or family is unable to give consent
- •Patient who use opioids or tramadol daily for >7 days before study medication administration(patient who, in the investigator's opinion, had or was developing opioid tolerance)
- •Patient who had a chronic pain condition or any significant medical disease, laboratory abnormality, or condition that, in the investigator's judgment, could have compromised the subject's welfare, ability to communicate with the study staff, complete study activities, or otherwise restricted study participation
- •Patient who had hypersensitivity to opioids, acetaminophen, or the inactive ingredients of the study medication
- •Patient who had known or suspected history of alcohol or drug abuse or dependence within the previous 1 year
- •Patient who had impaired liver function
- •Patient who had fever within first 48 hours post-operatively and required acetaminophen for fever reduction
研究组 & 干预措施
IV acetaminophen group
In addition to PCA (morphine or hydromorphone) all patients receive 1 gram of IV acetaminophen (100 ml ) 30 minutes prior to operation and every 6 hours thereafter for up to 5 days post-operatively or discharge.
干预措施: IV Acetaminophen (Drug)
Placebo Group
In addition to PCA (morphine or hydromorphone) all patients received placebo (100 ml normal saline) given 30 minutes prior to operation and every 6 hours thereafter for up to 5 days post-operatively or discharge
干预措施: Placebo (Drug)
结局指标
主要结局
Total opioid consumption
时间窗: 48 hours
pain control base on pain visual Analogue Scale Score (1-10)
时间窗: 48 hours
次要结局
- Time to diet ordered (TTDO)(through study completion, an average of 5 days)
- time to Return of GI function (ROGIF) [Flatus or bowel movement](through study completion, an average of 5 days)
- Length of hospital stay (LOHS)(through study completion, an average of 5 days)
- Occurrence of ileus(through study completion, an average of 5 days)
研究者
Amir H. Aryaie
MD
Jewish Hospital, Cincinnati, Ohio