Personalized Prediction of Persistent Postsurgical Pain
- Conditions
- Pain, Postoperative
- Registration Number
- NCT04864275
- Lead Sponsor
- Washington University School of Medicine
- Brief Summary
P5 is planned as a prospective observational study, collecting evidence-based perioperative data on patient history and demographics, physical function, cognitive measures, psychological, and biological markers associated with increased pain susceptibility, and psychophysical measures of pain processing.
The study will use daily ecologic momentary assessment (EMA) of physical and emotional parameters, and collect data on perioperative events.
Follow up will occur 3 months and 6 months postoperatively.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2750
- Adults age 18-75 who are candidates for major surgery (expected surgery duration >1 hour, and expected overnight admission to the hospital)
- Access to a smartphone
- Participants who do not speak English
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Persistent Postsurgical Pain (PPSP) up to 7 months following consent Clinically meaningful PPSP will be defined as pain in the surgical area present 3 months after surgery which fulfils one of the following criteria: 1) pain intensity on rest or movement ≥3 on 0-10 numerical rating scale (NRS), or 2) pain interference with any of the seven Brief Pain Inventory items (general activity, mood, walking ability, normal work \[including housework\], relations with other people, sleep, and enjoyment of life) ≥3 on 0-10 scale.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Washington University in St Louis
🇺🇸Saint Louis, Missouri, United States