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临床试验/NCT04336579
NCT04336579招募中不适用

Diaphragmatic Breathing Exercises As An Analgesia Adjunct in Total Knee Arthroplasty Patients in the Perioperative Period

University of Southern California1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年6月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Opioid Usage (morphine equivalents)

研究概览

简要总结

Rationale: While total knee replacements (TKA) are one of the most commonly performed surgical procedures in the United States, this procedure can also be very painful. Postoperative mobilization and rehabilitation is vital to a patient's recovery, but inadequate pain control can impede patients' progress. Diaphragmatic breathing is an additional non-pharmacological and non-invasive tool with no adverse effects that could aid in recovery. This will serve as a pilot study for a possible larger controlled trials.

详细描述

Study population: Patients (participants) undergoing total knee arthroplasty at Keck USC Hospital at HC3

Study methodology: Patients (participants) will be taught with the aide of a handout and instructional videos preoperatively and in the recovery room on how to perform diaphragmatic breathing exercises for post-operative pain control. Patient (participant) pain levels will be assessed using the visual analog scale (VAS). The investigators will then be comparing VAS scores and daily opioid doses (morphine equivalents) between the study group and a control group. The control group will include prior patients (participants) over the past year who underwent TKA at Keck Hospital and also had pain scores and opioid usage measured, but did not receive the breathing treatment.

Study endpoints: Endpoints will include: pain levels via VAS scale, anxiety levels via VAS scale, and opioid usage (morphine equivalents).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

年龄范围
50 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients (participants) undergoing total knee arthroplasty with a continuous peripheral nerve block catheter

排除标准

  • Inability to perform or learn diaphragmatic breathing exercises or do not wish to participate in diaphragmatic breathing or study protocol
  • Pregnant patients
  • Patients without continuous peripheral nerve block catheter

结局指标

主要结局

Opioid Usage (morphine equivalents)

时间窗: 1 day after intervention

Opioid Usage for pain

Anxiety Level

时间窗: 1 day after intervention

Verbal Analog Score - rate anxiety on 0-10 scale where 0 = no anxiety, 10 = worst possible pain

Pain Level

时间窗: 1 day after intervention

Verbal Analog Pain Score - rate pain on 0-10 scale where 0 =no pain, 10 = worst possible pain

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

Linda Rever

Clinical Associate Professor of Anesthesiology

University of Southern California

研究点 (1)

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