Personalized Prediction of Persistent Postsurgical Pain

NCT04864275 | Completed

• 1 other identifier: 202101123
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Outcome Measures

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.

  up to 7 months following consent

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• Participants who do not speak English

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University in St Louis

St Louis, Missouri, 63110, United States

Location

Related Publications (4)

• 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.

  PMID: 26966331 BACKGROUND

• 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.

  PMID: 23273105 BACKGROUND

• 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.

  PMID: 16698416 BACKGROUND

• 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.

  PMID: 41638723 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Simon Haroutounian, PhD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 24, 2021
• First Posted: April 28, 2021
• Study Start: September 10, 2021
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

US (1)