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OpenTrials
Completed

NCT Number: NCT04864275

Personalized Prediction of Persistent Postsurgical Pain

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University in St Louis

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Persistent Postsurgical Pain (PPSP)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Acronym: P5

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Apr 28, 2021
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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