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临床试验/NCT03510910
NCT03510910已完成4 期

Multimodal Analgesia With Acetaminophen vs. Narcotics Alone After Hip Arthroscopy

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年4月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
100
试验地点
1
主要终点
Patient Satisfaction

研究概览

简要总结

The purpose of this proposed study is to evaluate the efficacy of a multimodal approach to analgesia for patient's pain after hip arthroscopy and to also assess if this new approach will result in a reduction in post-operative narcotic use.

This study is a single-center, randomized prospective study comparing post-operative pain scores and narcotic consumption between individuals receiving acetaminophen along with a reduced quantity of Percocet (to be used as needed for breakthrough pain) and individuals receiving Percocet only. Both pain management options are considered to be standard of care. Both cohorts will receive aspirin for DVT prophylaxis and celecoxib for heterotopic ossification prophylaxis.

The primary objective of the study are to compare patients' narcotic consumption and reported pain following arthroscopic hip surgery, and determine if acetaminophen can provide adequate pain relief compared to a narcotic medication.

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
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA class I-II
  • Patients indicated and scheduled for arthroscopic hip surgery

排除标准

  • Contraindication to acetaminophen or oxycodone/acetaminophen (e.g. hypersensitivity, history of GI or bleeding disorder)
  • Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia, etc.)
  • Younger than 18 years of age or older than 65
  • Any patient considered a vulnerable subject
  • Patients on pain medication prior to surgery

研究组 & 干预措施

Acetaminophen along with a reduced quantity of Percocet

Experimental

干预措施: Acetaminophen (Drug)

Acetaminophen along with a reduced quantity of Percocet

Experimental

干预措施: Percocet (Drug)

Percocet only

Experimental

干预措施: Percocet (Drug)

结局指标

主要结局

Patient Satisfaction

时间窗: 7 days post-surgery

Satisfaction was reported on a Likert-type scale of 1-10 (the higher the score, the higher the satisfaction)

Morphine-equivalent Consumption

时间窗: 7 days post-surgery

Amount of oxycodone/acetaminophen (Percocet) in 5mg/325mg doses will be recorded in number of pills

Score on Visual Analog Scale (VAS) of Pain

时间窗: 7 days post-surgery

Pain severity scores at rest will be assessed by use of VAS. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." The higher the score, the worse the pain.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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