The Perioperative Pain Self-Management Program Trial

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

Detailed Description
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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.

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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Behavioral: Perioperative Pain Self-management (PePS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized to either receive the pain self-management sessions (PePS) or standard care (SC).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PePS<br>4 sessions of telephone CBT-based pain self-management in addition to standard perioperative care. | Behavioral: Perioperative Pain Self-management (PePS)<br>* 4 sessions of telephone CBT-based pain self-management.<br>* Other names: PePS;|
| No Intervention: Standard Care<br>Standard perioperative care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Pain Rating Scale | Surgical Site Pain The Numeric Rating Scale (NRS) is a 0-10 measure where 0 = no pain. | 6-months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| opioid use | Time to opioid cessation following surgery: daily opioid use will be collected via weekly phone calls for the first 6 weeks post-surgery. | time to cessation post surgery (weekly phone calls for the first 6 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative pain, opioid