Personalized Prediction of Persistent Postsurgical Pain

Pain, Postoperative Clinical Trial

— P5  

Official title:

Personalized Prediction of Persistent Postsurgical Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04864275
• Other study ID #: 202101123
• Status: Recruiting
• Start date: September 10, 2021
• Est. completion date: October 30, 2026

Study information

• Verified date: February 2024
• Source: Washington University School of Medicine
• Contact: Karen Frey
• Phone: 314-454-5980
• Email: freyk[@]wustl.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2750
• Est. completion date: October 30, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Locations

Country	Name	City	State
United States	Washington University in St Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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