Post-operative Analgesia in Elective, Soft-tissue Hand Surgery: A Randomized, Double Blind Comparison of Acetaminophen/Ibuprofen Versus Acetaminophen/Hydrocodone
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Efficacy Comparison of Pain Intensity Level
研究概览
简要总结
The purpose of this research study is to find out which combination of pain medications following surgery work the best and result in the fewest side effects.
详细描述
This is a prospective, randomized, double-blind study comparing the efficacy of acetaminophen/hydrocodone (AH) to acetaminophen/ibuprofen (AIBU) in providing adequate post-operative pain relief in elective, soft tissue hand surgery patients.
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
- Double (Participant, Investigator)
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 greater than or equal to 18
- •Male or Female (non-pregnant)
- •Elective, soft tissue hand surgery indicated based on diagnosis made by either clinical exam or diagnostic studies (ie nerve conduction study, EMG) or a combination of the two (carpal tunnel release, trigger finger release, first dorsal compartment release, ganglion cyst excision, second extensor compartment release)
- •Subjects are capable of giving informed consent
排除标准
- •Allergy to study medication
- •Any pre-existing pain condition requiring analgesia
- •Fibromyalgia
- •Recent upper gastrointestinal bleeding
- •Coagulopathy (primary or medication-related)
- •Renal impairment
- •Liver disease
- •Pregnancy
- •Patients who consent to the study but require unexpected admission, including those requiring admission resulting from operative complications, will be excluded before randomization
研究组 & 干预措施
Acetaminophen/Ibuprofen (AIBU) Group
Acetaminophen 500 mg and Ibuprofen 400 mg
干预措施: Acetaminophen/Ibuprofen (Drug)
Acetaminophen/Hydrocodone (AH) Group
Acetaminophen 325 mg and Hydrocodone 5 mg
干预措施: Acetaminophen/Hydrocodone (Drug)
结局指标
主要结局
Efficacy Comparison of Pain Intensity Level
时间窗: 1 week post-operatively
Subjects asked to fill out a patient diary recording their pain intensity level (on 100mm Visual Analog Scale) prior to taking study medication every 4 hours. The daily average pain intensity levels are reported as a score on a scale of 0-100, with higher score meaning worse outcome. The daily average pain levels were assessed daily for 1 week post-operatively, then compared between the 2 groups using a two-group Student's t-test.
次要结局
- Efficacy Comparison of Pain Relief(1 week postoperatively)
研究者
Alexander Payatakes, M.D.
Principal Investigator / Sponsor
Milton S. Hershey Medical Center