NCT02579538|Completed
Flexibility of Cognition And Persistent Pain
FlexCAPP
Cognitive Predictors of Persistent Post-surgical Pain (PPSP)
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FlexCAPP
Cognitive Predictors of Persistent Post-surgical Pain (PPSP)
Sponsor study identifier
observational
300
1 country
1
Study Start
September 1, 2015
Actual (reported)Primary Completion
March 1, 2018
Actual (reported)Study Completion
December 1, 2018
Actual (reported)This observational study aims to determine the association between preoperative cognitive flexibility and the risk of developing PPSP by preoperative administration of cognitive tests.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 1, 2015
Actual (reported)September 9, 2015
Actual (reported)October 19, 2015
Actual (reported)March 1, 2018
Actual (reported)December 1, 2018
Actual (reported)PPSP prevalence in relation to baseline TMT B minus A time
The time to complete TMT B test minus the time to complete TMT A test (B-A) at baseline between patients with persistent post surgical pain at six months follow-up, compared to patients without persistent post surgical pain.
Six months
PPSP prevalence in relation to baseline Stroop interference effect test score
The Stroop interference effect time (time to complete mixed color wording - time to complete same color wording) at baseline between patients with persistent post surgical pain at six months follow-up, compared to patients without persistent post surgical pain.
Six months
Comparison of cognitive test scores and severity of PPSP between patients undergoing total knee arthroplasty vs. patients undergoing thoracotomy/mastectomy
up to one year
Multiple regression analysis
up to one year
Patients undergoing unilateral total knee arthroplasty
Patients undergoing mastectomy, thoracotomy, or video-assisted thoracoscopic surgery (VATS)
Patients who are 18 to 85 years of age undergoing unilateral TKA for osteoarthritis, unilateral mastectomy for breast cancer, or thoracotomy or video-assisted thoracoscopic surgery for any non-cardiac indication will be recruited for participation in the study during their initial preoperative visit at the Washington University Center for Perioperative Assessment and Planning (CPAP). Patient eligibility will not be affected by the anesthetic plan including the potential use of regional anesthesia techniques.
Washington University in Saint Louis
St Louis, Missouri, 63110, United States
Attal N, Masselin-Dubois A, Martinez V, Jayr C, Albi A, Fermanian J, Bouhassira D, Baudic S. Does cognitive functioning predict chronic pain? Results from a prospective surgical cohort. Brain. 2014 Mar;137(Pt 3):904-17. doi: 10.1093/brain/awt354. Epub 2014 Jan 17.
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.
Simon Haroutounian, PhD
Washington University in Saint Louis
300 participants (actual enrollment reported by the registry).
First Submitted
September 9, 2015
First Posted
October 19, 2015
Study Start
September 1, 2015
Actual (reported)Single Dose Preoperative Gabapentin Use in Minimally Invasive Hysterectomy for Acute Pain Management
Contact the study team to confirm eligibility.
Solberg Nes L, Roach AR, Segerstrom SC. Executive functions, self-regulation, and chronic pain: a review. Ann Behav Med. 2009 Apr;37(2):173-83. doi: 10.1007/s12160-009-9096-5. Epub 2009 Apr 9.
Bonanno GA, Papa A, Lalande K, Westphal M, Coifman K. The importance of being flexible: the ability to both enhance and suppress emotional expression predicts long-term adjustment. Psychol Sci. 2004 Jul;15(7):482-7. doi: 10.1111/j.0956-7976.2004.00705.x.
McCracken LM, Vowles KE. Psychological flexibility and traditional pain management strategies in relation to patient functioning with chronic pain: an examination of a revised instrument. J Pain. 2007 Sep;8(9):700-7. doi: 10.1016/j.jpain.2007.04.008. Epub 2007 Jul 5.
Wicksell RK, Olsson GL, Hayes SC. Psychological flexibility as a mediator of improvement in Acceptance and Commitment Therapy for patients with chronic pain following whiplash. Eur J Pain. 2010 Nov;14(10):1059.e1-1059.e11. doi: 10.1016/j.ejpain.2010.05.001. Epub 2010 Jun 9.
Vila MR, Todorovic MS, Tang C, Fisher M, Steinberg A, Field B, Bottros MM, Avidan MS, Haroutounian S. Cognitive flexibility and persistent post-surgical pain: the FLEXCAPP prospective observational study. Br J Anaesth. 2020 May;124(5):614-622. doi: 10.1016/j.bja.2020.02.002. Epub 2020 Mar 10.
Primary Completion
March 1, 2018
Actual (reported)Study Completion
December 1, 2018
Actual (reported)Last Updated
January 28, 2020
Record last verified: 2020-01
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