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Personalized Prediction of Persistent Postsurgical Pain

NCT ID: NCT04864275

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-10

Study Completion Date

2025-09-30

Brief Summary

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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

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Conditions

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Pain, Postoperative

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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simon.haroutounian

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Simon Haroutounian, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

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Washington University in St Louis

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 23273105 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16698416 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26966331 (View on PubMed)

Other Identifiers

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202101123

Identifier Type: -

Identifier Source: org_study_id