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CompletedNCT04864275P5Updated Dec 17, 2025

Personalized Prediction of Persistent Postsurgical Pain

An observational study in Pain, Postoperative, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-17.

Sponsored by Washington University School of Medicine · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,500
Ages
18 Years to 75 Years
Sex
All
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Study 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.

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Conditions studied

  • Pain, Postoperative

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In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 2,500 is above the median of 102 across 608 observational studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who are 18 to 75 years of age and candidates for major surgery at Barnes-Jewish Hospital (expected surgery duration >1h, 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)) will be approached for consent to this study. Participants will be recruited for participation in the study during their initial preoperative visit to the Center for Perioperative Assessment and Planning (CPAP).

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

Exclusion Criteria:

  • Participants who do not speak English
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,500 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. Persistent Postsurgical Pain (PPSP)

    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.

    Time frame: up to 7 months following consent

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Study locations

1 site
  • Washington University in St Louis
    St Louis, Missouri 63110, United States
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References and documents

Publications

  • Weiser TG, Haynes AB, Molina G, Lipsitz SR, Esquivel MM, Uribe-Leitz T, Fu R, Azad T, Chao TE, Berry WR, Gawande AA. Size and distribution of the global volume of surgery in 2012. Bull World Health Organ. 2016 Mar 1;94(3):201-209F. doi: 10.2471/BLT.15.159293. PubMed 26966331 ↗
  • Haroutiunian S, Nikolajsen L, Finnerup NB, Jensen TS. The neuropathic component in persistent postsurgical pain: a systematic literature review. Pain. 2013 Jan;154(1):95-102. doi: 10.1016/j.pain.2012.09.010. PubMed 23273105 ↗
  • Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X. PubMed 16698416 ↗
  • Holzer KJ, Alaverdyan H, Xu Z, Frumkin MR, Frey KA, Gregory SH, Rodebaugh TL, Lu C, King CR, Head D, Kannampallil T, Haroutounian S. Protocol for Personalised Prediction of Persistent Postsurgical Pain. BMJ Open. 2026 Feb 4;16(2):e107055. doi: 10.1136/bmjopen-2025-107055. PubMed 41638723 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04864275
Lead sponsor
Washington University School of Medicine
Responsible party
simon.haroutounian (Associate Professor, Washington University School of Medicine) — Principal investigator
First posted
Apr 28, 2021
Start date
Sep 10, 2021
Primary completion
Sep 30, 2025
Completion
Sep 30, 2025
Last update
Dec 17, 2025

Study contacts

Simon Haroutounian, PhD
principal investigator · Associate Professor

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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