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임상시험 NCT04336579은(는) 마취 및 진통에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요.
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Diaphragmatic Breathing Exercises in Total Knee Arthroplasty Patients

모집중
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임상시험 NCT04336579은(는) 마취 및 진통에 대해 알아보는 관찰연구입니다. 현재 상태는 모집중이며, 연구는 2024년 6월 10일에 시작되어 50명의 참여자를 모집하고 있습니다. 서던캘리포니아 대학교이(가) 진행하며, 2024년 10월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2024년 8월 27일에 갱신되었습니다.
간단한 개요
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.
상세한 설명
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).

공식 제목

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

질환/상태
마취 및 진통
기타 연구 식별자
  • HS-19-00223
NCT 번호
실제 연구 시작일
2024-06-10
최신 업데이트 게시
2024-08-27
예상 연구 완료일
2024-10-01
계획된 등록 인원
50
연구종류
관찰연구
상태
모집중
시험군 / 개입
참가자 그룹/시험군개입/치료
Control
Retrospective review of patients (participants) with standard analgesia post total knee arthroplasty
해당 없음
Diaphragmatic Breathing
Intervention: Participants will perform diaphragmatic breathing exercises postoperatively as part of their multi-modal pain regimen.
횡격막 호흡
Simple diaphragmatic breathing exercise
주요결과변수
결과변수측정값 설명시간 범위
Pain Level
Verbal Analog Pain Score - rate pain on 0-10 scale where 0=no pain, 10= worst possible pain
Prior to intervention
Opioid Usage (morphine equivalents)
Opioid Usage for pain
Prior to intervention
Anxiety Level
Verbal Analog Score -rate anxiety on 0-10 scale where 0= no anxiety, 10= worst possible anxiety
Prior to intervention
Pain Level
Verbal Analog Pain Score - rate pain on 0-10 scale where 0 =no pain, 10 = worst possible pain
15 minutes after intervention
Opioid Usage (morphine equivalents)
Opioid Usage for pain
15 minutes after intervention
Anxiety Level
Verbal Analog Score - rate anxiety on 0-10 scale where 0 =no anxiety, 10 = worst possible anxiety
15 minutes after intervention
Pain Level
Verbal Analog Pain Score - rate pain on 0-10 scale where 0 =no pain, 10 = worst possible pain
6 hours after intervention
Opioid Usage (morphine equivalents)
Opioid Usage for pain
6 hours after intervention
Anxiety Level
Verbal Analog Score- rate anxiety on 0-10 scale where 0 =no anxiety, 10 = worst possible anxiety
6 hours after intervention
Pain Level
Verbal Analog Pain Score - rate pain on 0-10 scale where 0 =no pain, 10 = worst possible pain
1 day after intervention
Opioid Usage (morphine equivalents)
Opioid Usage for pain
1 day after intervention
Anxiety Level
Verbal Analog Score - rate anxiety on 0-10 scale where 0 = no anxiety, 10 = worst possible pain
1 day after intervention
적격성 기준

연령대
성인, 노인
최소 연령
50 Years
참여 가능한 성별
전체
  • Patients (participants) undergoing total knee arthroplasty with a continuous peripheral nerve block catheter

  • 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
연구 책임자
Linda Rever, 책임연구자, Clinical Associate Professor of Anesthesiology, University of Southern California
연구 대표 연락처
연락처: Linda J Rever, MD, 3234427400, [email protected]
1 1개국에 임상시험 장소

California

Keck Hospital of USC, Los Angeles, California, 90033, United States
모집중