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临床试验/NCT02313675
NCT02313675已完成4 期

Comparing Pain Outcomes of Intra-operative IV Tylenol and/or IV Toradol Administration for Carpal Tunnel Release and Distal Radius Fracture Surgeries

John Fowler1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2015年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
44
试验地点
1
主要终点
Postoperative Pain (Pain Scores From 0-10 Scale)

研究概览

简要总结

The purpose of this study is to determine the efficacy of intra-operative administration of IV tylenol and/or IV toradol in minimizing post-operative pain for carpal tunnel patients and distal radius fracture patients.

详细描述

The study population will include patients presenting for surgery with carpal tunnel syndrome as well as surgical treatment of distal radius fracture. Patients will be treated intra-operatively with either IV tylenol, IV toradol, both, or neither. All patients will receive the standard post-operative prescriptions for pain management. Daily pain surveys scoring pain from 0-10 will be distributed to the subjects to be filled out over the course of 10 days prior to first post-operative visit, usually 10-14 days later. Number of pain pills used before the first post-operative visit will also be measured.

We hypothesize that the effects of intra-operative administration of IV tylenol and/or IV toradol will have a significant effect on decreasing post-operative pain in the first 10 days following distal radius fracture surgeries, with a significant difference in pain described as at least a 2 points on a 0-10 pain scale.

We also hypothesize that intra-operative administration of IV tylenol and/or IV toradol will not have such significant effect on decreasing post-operative pain for carpal tunnel release surgery.

A secondary aim is to evaluate the post-operative opioid consumption of patients within these treatment groups. We hypothesize that opioid consumption will be decreased in the groups receiving IV tylenol and/or toradol for distal radius fracture surgery compared to the placebo group. We do not expect such a difference for the carpal tunnel release surgery group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • carpal tunnel release surgery candidates,
  • distal radius fracture surgery candidates

排除标准

  • under 18 years of age,
  • pregnant women,
  • prisoners

研究组 & 干预措施

IV tylenol

Experimental

One time intra-operative IV acetaminophen administration

干预措施: Acetaminophen (Drug)

IV toradol

Experimental

One time intra-operative IV ketorolac thromethamine administration

干预措施: Ketorolac Tromethamine (Drug)

IV tylenol/toradol combination

Experimental

One time intra-operative IV combination of acetaminophen/ketorolac administration

干预措施: Acetaminophen (Drug)

IV tylenol/toradol combination

Experimental

One time intra-operative IV combination of acetaminophen/ketorolac administration

干预措施: Ketorolac Tromethamine (Drug)

saline

Placebo Comparator

One time intra-operative 50ml IV normal saline administration

干预措施: Saline (Drug)

结局指标

主要结局

Postoperative Pain (Pain Scores From 0-10 Scale)

时间窗: 7 days

This is an ordinal pain scale. The patient picks a number from 0-10 scale every 4 hours for 7 days post-operatively. 0 is no pain, 10 is the worst pain imaginable. Lower scores would be preferable to higher scores.

次要结局

  • Opioid Consumption (Number of Pills Taken)(7 days)

研究者

发起方
John Fowler
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

John Fowler

MD

University of Pittsburgh

研究点 (1)

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