Clinical trial NCT03047434: Characterization of PostOp Pain in Shoulder and Knee Arthroscopy
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Surgical Pain
Lead sponsor: Defense and Veterans Center for Integrative Pain Management
Sponsor class: OTHER
First posted: 2017-02-09
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1. 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.
2. 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.

Brief summary: The purpose of this study is to describe the chronology of post operative pain in patients undergoing total knee arthroplasty and total hip arthroplasty. Further, within this population the predictive validity of the Defense and Veterans Pain Rating Scale will be assessed for persistent post surgical pain.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients undergoing the following surgeries: Total Knee Arthroscopy, Total Hip Arthroscopy.
2. DEERS eligible

Exclusion Criteria:

1. Younger than 18
2. Refuses participation
3. Cannot understand English
4. Has cognitive deficiencies
5. Ambulatory surgical status where they go home same day.

Primary outcomes:
measure: 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
timeFrame: 3-months and 6-months post-surgery
measure: 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.
timeFrame: 3-months and 6-months post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: WRNMMC
state: Maryland
Study officials:
affiliation: Walter Reed National Military Medical Center
name: Harold Gelfand
role: PRINCIPAL_INVESTIGATOR
References:
citation: Giordano NA, Kent M, Buckenmaier CC 3rd, Mauntel TC, Dickens JF, Millington M, Highland KB. A Longitudinal Comparison of Patient-Reported Outcomes Measurement Information System to Legacy Scales in Knee and Shoulder Arthroscopy Patients. Arthroscopy. 2021 Jan;37(1):185-194.e2. doi: 10.1016/j.arthro.2020.07.026. Epub 2020 Jul 25.