Characterization of PostOp Pain in Shoulder and Knee Arthroscopy (PurpleRain)
Characterization of Postoperative Pain in Shoulder Arthroscopy and Knee Arthroscopy and Assessment of the Defense and Veterans Pain Rating Scale for Persistent Post-Surgical Pain
연구 개요
상세 설명
This is a prospective descriptive correlational design looking to characterize postoperative pain variables across various procedures that historically have significant levels of persistent post-surgical pain. Further, bivariate correlations at different time points will be examined to see how DVPRS along with Pain Assessment Screening Tool and Outcomes Registry (PASTOR) correlates with other measures.
Methodology/Technical Approach A total goal of 250 participants will be queried regarding their postoperative pain experience following shoulder arthroscopy and knee arthroscopy. Descriptive multidimensional tools (the DVPRS and the electronic Pain Assessment Screening Tool and Outcomes Registry (PASTOR)) will be used preoperative either during their preoperative surgical visit or the day of surgery and extending to 6 months postoperatively. As these tools have been utilized in previous studies for the prediction of persistent post surgical pain, the DVPRS will additionally be evaluated for its predictive validity as it is a short, easy-to-administer, bedside tool.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Maryland
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Bethesda, Maryland, 미국, 20889
- WRNMMC
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
- Male and female military health care beneficiaries age 18 years and older presenting any of the following surgeries: total knee arthroplasty and total hip arthroplasty.
- The recruitment and participation in this study will have minimal impact on surrounding health care activities. This study is measuring pain in a more specific manner than usual to describe the perioperative pain experience and evaluate the predictive capability of the DVPRS. Measurements in this study will not be used to make therapeutic decisions. Participants will be screened from the Surgical Scheduling System (S3) and joint arthroplasty surgeon's scheduling nurse prior to surgery and approached upon their preoperative visit with their surgeon.
설명
Inclusion Criteria:
- Patients undergoing the following surgeries: Total Knee Arthroscopy, Total Hip Arthroscopy.
- DEERS eligible
Exclusion Criteria:
- Younger than 18
- Refuses participation
- Cannot understand English
- Has cognitive deficiencies
- Ambulatory surgical status where they go home same day.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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To characterize the chronology/natural history of the postoperative pain experience in patients undergoing shoulder arthroscopy, knee, ankle arthroscopy in a multidimensional fashion from the immediate postoperative phase until 6 months post-surgery
기간: 3-months and 6-months post-surgery
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Describe biopsychosocial functioning, as indicated by PROMIS domain scales and the DVPRS, at each time point, as well as longitudinal, polynomial data patterns for the aggregated sample. Examine whether longitudinal patterns vary according to surgical factors (e.g. procedure type, type of regional intervention received). Identify factors associated with low functioning and persistent opioid use at 3-months and 6-months post-surgery. |
3-months and 6-months post-surgery
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To assess the predictive validity of the DVPRS and PASTOR for persistent post-surgical pain at 3 and 6 months in patients undergoing the above surgical procedures.
기간: 3-months and 6-months post-surgery
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) When accounting for baseline levels, does postoperative Day 7 DVPRS scores predict persistent post- surgical pain at 3 months, as defined as 1 SD worse functioning on PROMIS Pain Interference?
b) When accounting for baseline levels, does postoperative Day 7 DVPRS scores predict persistent post-surgical pain at 3 months, as defined as 1 SD worse functioning on PROMIS Neuropathic?
c) What are the optimal cut-offs for the DVPRS at Day 7 in predicting persistent post-surgical pain at 3 months, as defined as 1 SD worse functioning on PROMIS Pain Interference?
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3-months and 6-months post-surgery
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공동 작업자 및 조사자
수사관
- 수석 연구원: Harold Gelfand, Walter Reed National Military Medical Center
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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