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Flexibility of Cognition And Persistent Pain (FlexCAPP)

The Washington University logo

The Washington University

Status

Completed

Conditions

Pain, Postoperative

Study type

Observational

Funder types

Other

Identifiers

NCT02579538
201508145

Details and patient eligibility

About

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

Full 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.

Enrollment

300 patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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


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

Trial design

300 participants in 2 patient groups

Total Knee Arthroplasty
Description:
Patients undergoing unilateral total knee arthroplasty
Thoracic/Breast Surgery
Description:
Patients undergoing mastectomy, thoracotomy, or video-assisted thoracoscopic surgery (VATS)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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