Characterization of Bio-psychosocial Pain Profiles in the Perioperative Period

NCT03081299 | Completed

• 1 other identifier: 500094-1
• Study Type: observational
• Target: 471
• Locations: 1 country
• Sites: 1

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

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (3)

• DVPRS

  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.

  perioperatively to 6 months

• PASTOR/PROMIS

  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

  perioperatively to 6 months

• Pain phenotypes

  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)

  perioperatively to 6 months

Study Arms (6)

Total Knee Arthroplasty

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.

Total Hip Arthroplasty

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.

Mastectomy

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.

Thoracic 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.

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.

Spinal Fusion

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female military health care beneficiaries age between 18 and 80 years old presenting any of the following surgeries: mastectomy, thoracic surgery, total knee arthroplasty, total hip arthroplasty, spinal fusion, and major abdominal surgery.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Defense and Veterans Center for Integrative Pain Management: lead
• Pacira Pharmaceuticals, Inc: collaborator

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Related Publications (1)

• Giordano NA, Kane A, Jannace KC, Rojas W, Lindl MJ, Lujan E, Gelfand H, Kent ML, Highland KB. Discrete and Dynamic Postoperative Pain Catastrophizing Trajectories Across 6 Months: A Prospective Observational Study. Arch Phys Med Rehabil. 2020 Oct;101(10):1754-1762. doi: 10.1016/j.apmr.2020.04.023. Epub 2020 May 21.

  PMID: 32445848 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Michael Kent, MD

  Defense and Veterans Center for Integrative Pain Management

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: March 16, 2017
• Study Start: May 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: May 1, 2019
• Last Updated: March 25, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)