Post Surgical Pain Clinical Trial
— PurpleRainOfficial 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
NCT number | NCT03047434 |
Other study ID # | 413667 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 9, 2016 |
Est. completion date | January 24, 2020 |
Verified date | February 2020 |
Source | Defense and Veterans Center for Integrative Pain Management |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 250 |
Est. completion date | January 24, 2020 |
Est. primary completion date | January 24, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | WRNMMC | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
Defense and Veterans Center for Integrative Pain Management |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Primary | 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. | ) 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? | 3-months and 6-months post-surgery |
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