Pain, PostoperativeNCT03081299
Characterization of Bio-psychosocial Pain Profiles in the Perioperative Period
An observational study of Pain, Postoperative, run by Defense and Veterans Center for Integrative Pain Management at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Postoperative
- How many people
- 471 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
About this study
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
Read the 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.
- Conditions
- Pain, Postoperative
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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)
Measured: perioperatively to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2017
- Study startMay 2016
- Primary completionNov 2018
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 471 participants (actual)
Sponsor and investigators
- Lead sponsor
- Defense and Veterans Center for Integrative Pain Management
- Sponsor type
- University, hospital or other
- Collaborators
- Pacira Pharmaceuticals, Inc
- Responsible party
- Sponsor
- Investigators
- Michael Kent, MD, Principal investigator, Defense and Veterans Center for Integrative Pain Management
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081299
- Sponsor's protocol ID
- 500094-1
- Status last verified
- Mar 2021
- First submitted
- 10 Mar 2017
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32445848
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Bio-psychosocial Pain Profiles in the Perioperative Period
- ClinicalTrials.gov ID
- NCT03081299
- Acronym / sponsor ID
- 500094-1
- Conditions
- Pain, Postoperative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 471 participants (actual)
- Lead sponsor
- Defense and Veterans Center for Integrative Pain ManagementUniversity, hospital or other
- Collaborators
- Pacira Pharmaceuticals, Inc
- Study start
- May 2016 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 16 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
DVPRS
Time frame: 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
Time frame: 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
Pain phenotypes
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- Derived from this study: PubMed 32445848Giordano 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Kent, MD principal investigator
Defense and Veterans Center for Integrative Pain Management
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative, run by Defense and Veterans Center for Integrative Pain Management at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DVPRS (time frame: perioperatively to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03081299, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2021.