Characterization of PostOp Pain in Shoulder and Knee Arthroscopy

Post Surgical Pain Clinical Trial

— PurpleRain  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03047434
• Other study ID #: 413667
• Status: Completed
• Start date: November 9, 2016
• Est. completion date: January 24, 2020

Study information

• Verified date: February 2020
• Source: Defense and Veterans Center for Integrative Pain Management
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Post Surgical Pain
• Shoulder Pain

Locations

Country	Name	City	State
United States	WRNMMC	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Defense and Veterans Center for Integrative Pain Management

Country where clinical trial is conducted

United States, 

Outcome

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