Characterization of Bio-psychosocial Pain Profiles in the Perioperative Period

Completed

• Conditions: Pain, Postoperative

• Registration Number: NCT03081299
• Lead Sponsor: Defense and Veterans Center for Integrative Pain Management

Brief Summary

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

Detailed Description

This is a two institution (Naval Medical Center San Diego and Walter Reed National Military Medical Center) prospective descriptive correlational design looking to characterize postoperative pain variables across various procedures that historically have significant levels of persistent post-surgical pain.

A total goal of 1500 subjects (750 subjects at Walter Reed National Military Medical Center and 750 subjects at Naval Medical Center San Diego) will be queried regarding their postoperative pain experience following mastectomy, thoracic surgery, total knee arthroplasty, total hip arthroplasty, spinal fusion, and major abdominal surgery. Descriptive multidimensional tools (the Defense and Veterans Pain Rating Scale (DVPRS) and the electronic Pain Assessment Screening Tool and Outcomes Registry (PASTOR) will be used preoperatively, as an inpatient, and up to 6 months postoperatively.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2017-03-10
• Study First Submitted QC: 2017-03-10
• Study First Posted: 2017-03-16
• Primary Completion: 2018-11
• Study Completion: 2019-05
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-24
• Last Update Posted: 2021-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 471

Inclusion Criteria

• Be between the ages of 18 and 80 and having any of the following surgical procedures: mastectomy, thoracic surgery, total knee arthroplasty, total hip arthroplasty, spinal fusion, and major abdominal surgery.

DEERS eligible

Exclusion Criteria

• Total Hip/Total Knee arthroplasty revision Younger than 18 years old Refuse participation Cannot understand English Has cognitive deficiencies (subject unable to provide consent for the study, subject unable to complete initial post consent measures)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain phenotypes	perioperatively to 6 months	To describe various pain phenotypes via multidimensional pain measures throughout the subacute (7 days to 6 months) perioperative period. This description will focus on certain time points but also how such measures change over time (ie pain trajectories)
DVPRS	perioperatively to 6 months	To determine how predictive PASTOR/PROMIS measures are for moderate to severe acute postoperative pain as measured by the DVPRS within the first 48 hours postoperatively for all surgical groups and between surgical groups.
PASTOR/PROMIS	perioperatively to 6 months	To assess any predictive/correlative capability of early postoperative PASTOR/PROMIS measures (7 days,14 days, and 1 month postoperatively) in the prediction of persistent pain at 3 and 6 months for all surgical groups and between surgical groups

Trial Locations

Locations (1)

Walter Reed National Military Medical Center; 🇺🇸 Bethesda, Maryland, United States