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The Perioperative Pain Self-Management Program Trial

Preventing Chronic Post-Surgical Pain and Prolonged Opioid Use: The Perioperative Pain Self-Management Program

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04979429
Acronym
PePS
Enrollment
401
Registered
2021-07-28
Start date
2021-08-03
Completion date
2026-06-15
Last updated
2026-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

postoperative pain, opioid

Brief summary

This study will trial the impact of teaching surgical patients a pain self-management approach to compliment medical post-surgical pain management.

Detailed description

Surgery can precipitate the development of both chronic pain and long-term opioid use. There is a need for strategies to augment perioperative pharmacotherapeutic management of pain with non-pharmacologic strategies to prevent long-term sequelae. Psychological interventions such as cognitive behavioral therapy (CBT) can effectively reduce distress and improve functioning among patients with chronic pain. While CBT has been used extensively in patients with established chronic pain, it has not been used as a preventive intervention targeting the transition from acute to chronic postsurgical pain. The Perioperative Pain Self-management (PePS) program has the potential to reduce the incidence of chronic post-surgical pain and long-term opioid use among Veterans. This study will: Examine the efficacy of PePS compared to standard care on 6-month pain (primary outcome), mood and functioning outcomes as well as time to post-surgical opioid and other analgesic use cessation.

Interventions

BEHAVIORALPerioperative Pain Self-management (PePS)

4 sessions of telephone CBT-based pain self-management.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

The outcomes assessor will be blinded to randomization status.

Intervention model description

Participants will be randomized to either receive the pain self-management sessions (PePS) or standard care (SC).

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* scheduled for total hip, knee, or shoulder joint arthroplasty through the Iowa City, IA, Des Moines, IA, Minneapolis, IA, or Milwaukee WI, VA medical centers

Exclusion criteria

* inability to complete study forms/procedures because of a language/literacy barrier * active bipolar or psychotic disorder * history of brain injury * dementia * CBT therapy within the past year * lack of access to a telephone for PePS sessions

Design outcomes

Primary

MeasureTime frameDescription
Numeric Pain Rating Scale6-months post-surgerySurgical Site Pain The Numeric Rating Scale (NRS) is a 0-10 measure where 0 = no pain.

Secondary

MeasureTime frameDescription
opioid usetime to cessation post surgery (weekly phone calls for the first 6 weeks)Time to opioid cessation following surgery: daily opioid use will be collected via weekly phone calls for the first 6 weeks post-surgery.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDiana J. Burgess, PhD

Minneapolis VA Health Care System, Minneapolis, MN

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 3, 2026