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Personalized Prediction of Persistent Postsurgical Pain

Personalized Prediction of Persistent Postsurgical Pain

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04864275
Acronym
P5
Enrollment
2500
Registered
2021-04-28
Start date
2021-09-10
Completion date
2025-09-30
Last updated
2025-12-17

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

Conditions

Pain, Postoperative

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.

Interventions

None listed

Sponsors

Washington University School of Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Adults age 18-75 who are candidates for major surgery (expected surgery duration \>1 hour, and expected overnight admission to the hospital), or having one of the following procedures, even if outpatient (total joint replacement, hysterectomy, inguinal hernia repair, breast surgery, or video-assisted thoracic surgery (VATS)). * Access to a smartphone

Exclusion criteria

* Participants who do not speak English

Design outcomes

Primary

MeasureTime frameDescription
Persistent Postsurgical Pain (PPSP)up to 7 months following consentClinically 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026