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临床试验/NCT02779166
NCT02779166已完成不适用

Evaluation of Perioperative Celecoxib for Hip Arthroscopy

Northwestern University0 个研究点目标入组 98 人开始时间: 2012年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
98
主要终点
Total Narcotic Consumption in the Post Anesthesia Care Unit (PACU)

研究概览

简要总结

Celecoxib is commonly used for perioperative pain control for certain orthopaedic procedures. It has been shown to be successful in assisting in pain control for knee arthroscopy. It has not previously been studied in hip arthroscopy. This is a double blinded randomized controlled trial to determine the efficacy of celecoxib in perioperative pain control for hip arthroscopy.

详细描述

This study examines the efficacy of perioperative dose of celecoxib in pain management after hip arthroscopy. Perioperative administration of celecoxib has been shown to improve pain control after knee arthroscopy, but this has not yet been studied in the hip. In this study, patients are randomized to receive either 400mg celecoxib or placebo 1 hour prior to undergoing hip arthroscopy surgery. Postoperatively, patients are monitored for pain on the VAS scale, narcotic use, and meeting discharge criteria. The study will enroll 100 patients. Patients are approached for informed consent on the day of surgery. Pain scores, narcotic use, and time to discharge in the celecoxib group are compared to the placebo group.

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
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

入选标准

  • All patients who are undergoing a hip arthroscopy procedure at Northwestern Memorial Hospital with Dr. Michael Terry.

排除标准

  • Pregnant women and any patient under the age of 18 years.

研究组 & 干预措施

Intervention

Experimental

Received 400mg celecoxib prior to surgery

干预措施: Celecoxib (Drug)

Placebo

Placebo Comparator

Received placebo pill prior to surgery

干预措施: placebo (Drug)

结局指标

主要结局

Total Narcotic Consumption in the Post Anesthesia Care Unit (PACU)

时间窗: duration of PACU stay,immediate post op period up to a maximum of 4 hours postoperatively

Monitored consumption of narcotic medications following surgery, measured in morphine equivalents

Visual Analog Score for Pain (VAS) in the Immediate Post Operative Period

时间窗: Pre operative on day of surgery, immediately following OR close, 1 hr post operatively, 2 hrs post operatively

The pain VAS is a uni dimensional measure of pain intensity. It is a continuous scale comprised of a 0-10 pain rating. A score of 0 indicates no pain while a score of 10 would indicate extreme pain.

Time to Discharge Following Surgery

时间窗: time from OR to discharge, up to a maximum of 6 hours postoperatively

Total time to discharge from OR close following surgery, measured in minutes

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Terry

Associate Professor

Northwestern University

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