Personalized Prediction of Persistent Postsurgical Pain (P5)

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative

• Study Type: Observational
• Enrollment (Estimated): 2750

Contacts and Locations

• Study Contact: Name: Karen Frey; Phone Number: 314-454-5980; Email: freyk@wustl.edu

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University in St Louis
      • Contact: Washington University I St Louis; Email: simon.haroutounian@wustl.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• 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) 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).

Description

Inclusion Criteria:

• Adults age 18-75 who are candidates for major surgery (expected surgery duration >1 hour, and expected overnight admission to the hospital)
• Access to a smartphone

Exclusion Criteria:

• Participants who do not speak English

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Simon Haroutounian, PhD, Associate Professor

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2021
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: April 24, 2021
• First Submitted That Met QC Criteria: April 24, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 202101123

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No