Clinical trial NCT02579538: Flexibility of Cognition And Persistent Pain
Official title: Cognitive Predictors of Persistent Post-surgical Pain (PPSP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Keywords: Total Knee Arthroplasty
Thoracotomy
Mastectomy
Video-Assisted Thoracoscopic Surgery (VATS)
Persistent Pain
Cognitive Flexibility
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2015-10-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: This observational study aims to determine the association between preoperative cognitive flexibility and the risk of developing PPSP by preoperative administration of cognitive tests.

Detailed description: Postoperative pain is a normal, physiologic, protective response to tissue injury that routinely resolves after healing of the surgical site. However, in some patients, pain persists long after surgery. PPSP is a diagnosis of exclusion that has most consistently been defined as pain that (1) developed after a surgical procedure, (2) is not residual from a preexisting condition, (3) has lasted for at least two months, and (4) is not attributable to other causes. One suggested risk factor for PPSP is poorer performance on tests of cognitive flexibility. Two common tests of cognitive flexibility are the Trail Making Tests (TMT) A and B and the Color Word Matching Stroop Test (CWMST).

Three hundred patients undergoing either total knee arthroplasty or thoracotomy/mastectomy will be enrolled. During preoperative evaluation, participants will complete the TMT and CWMST. Subjects will be followed prospectively and will complete surveys at one month, six months, and one year postoperatively to assess PPSP prevalence and intensity.

Eligibility criteria: Total Knee Arthroplasty (TKA) patients

- Inclusion criteria: Adults age 18 to 85 undergoing unilateral TKA for osteoarthritis English as primary language

- Exclusion criteria: Bilateral procedure Unable to complete cognitive testing Surgical indication for condition other than osteoarthritis (i.e. rheumatoid arthritis, spondylarthropathy) Prior knee surgery

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Thoracotomy/mastectomy patients

- Inclusion criteria: Females age 18 to 85 undergoing mastectomy for breast cancer OR Adults age 18 to 85 undergoing unilateral open thoracotomy or video-assisted thoracoscopic surgery (VATS) for any non-cardiac etiology English as primary language

- Exclusion criteria: Bilateral procedure Unable to complete cognitive testing Plan for breast reconstruction Prior breast/thoracic surgery

Primary outcomes:
measure: PPSP prevalence in relation to baseline TMT B minus A time
timeFrame: Six months
measure: PPSP prevalence in relation to baseline Stroop interference effect test score
timeFrame: Six months
Secondary outcomes:
measure: Comparison of cognitive test scores and severity of PPSP between patients undergoing total knee arthroplasty vs. patients undergoing thoracotomy/mastectomy
timeFrame: up to one year
measure: Multiple regression analysis
timeFrame: up to one year
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in Saint Louis
state: Missouri
Study officials:
affiliation: Washington University in Saint Louis
name: Simon Haroutounian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.