Comparison of Opiranserin/Acetaminophen Versus Ibuprofen/Acetaminophen for Postoperative Pain Management After Minimally Invasive Cholecystectomy: A Randomized, Controlled, Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Area under the curve of the pain score at rest through 12 hours (NRS·h)
研究概览
简要总结
The purpose of this study is to evaluate whether the combination therapy of opiranserin and acetaminophen is non-inferior to the combination of non-steroidal anti-inflammatory drugs (NSAIDs) and acetaminophen for postoperative pain management after minimally invasive cholecystectomy.
This is a single-center, randomized, controlled, non-inferiority clinical trial in adult patients undergoing minimally invasive cholecystectomy. Participants will be randomly assigned to either the Treatement group (opiranserin + acetaminophen) or the control group (NSAIDs + acetaminophen) in a 1:1 ratio to compare the analgesic efficacy and safety between the two analgesic regimens.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, care providers, investigators, and oucome assessors will be blinded to the group assignment.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient undergoing minimally invasive cholecystectomy
排除标准
- •Known hypersensitivity or allergy to acetaminophen, NSAIDs, opiranserin, or fentanyl.
- •pre-existing chronic pain,
- •clinically significant ECG findings (QRS > 200 msec, QTcF >450 msec)
- •severe renal impairment
- •severe hepatic impairment
研究组 & 干预措施
Opiranserin+Acetaminophen group
In the Opiranserin+Acetaminophen group, opiranserine 1000mg infusion will be provided over 10 hr. IV Acetaminophen 1g will be provided q 8h until 24 h potperatively.
干预措施: Opiranserin+Acetaminophen (Drug)
Acetaminophen+NSAIDs group
In the Acetaminophen+NSAIDs group, Normal saline 500 ml will be provided over 10hr. IV Acetaminophen 1g and ibuprofen 300mg will be provided q 8h until 24 h potperatively.
干预措施: Acetaminophen+NSAIDs (Drug)
结局指标
主要结局
Area under the curve of the pain score at rest through 12 hours (NRS·h)
时间窗: Until 12 hours postoperatively
Area under the curve of the numeric rating scale pain score at rest through 12 hours (Numerical Rating Scale·h), Pain score will be assess with the numerical rating scale (NRS), ranging from 0 (0, no pain) to 10 (maximum, worst pain), higher scores indicate greater pain intensity.
次要结局
- Area under the curve of the pain score at rest through 24 hours(until 24hours postoperatively)
- pain at rest(at 0.5, 2, 4, 6, 12, 18, 24hours postoperatively)
- pain during movement(at 0.5, 2, 4, 6, 12, 18, 24hours postoperatively)
- nausea severity(until 24hours)
- patient satisfaction(24hours postoperatively)
- Quality of Recovery(24hours postoperatively)
研究者
Young Song
Professor
Gangnam Severance Hospital