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Completed

NCT Number: NCT02579538

Flexibility of Cognition And Persistent Pain

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

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University in Saint Louis

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. PPSP prevalence in relation to baseline TMT B minus A time

    Time frame: Six months

    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.

  2. PPSP prevalence in relation to baseline Stroop interference effect test score

    Time frame: Six months

    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.

Secondary outcomes

  1. Comparison of cognitive test scores and severity of PPSP between patients undergoing total knee arthroplasty vs. patients undergoing thoracotomy/mastectomy

    Time frame: up to one year

    Association between baseline TMT B score and Stroop color interference effect results and severity of PPSP at six months follow-up in patients undergoing total knee arthroplasty vs. patients undergoing thoracotomy/mastectomy

  2. Multiple regression analysis

    Time frame: up to one year

    Association of the following risk factors with PPSP at six months: cognitive flexibility (TMT and CWMST), age, gender, BMI, type of surgery, use of regional anesthesia, presence of preoperative pain, preoperative anxiety or depression, presence of prior stressful life events, and presence of severe acute postoperative pain)

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Cognitive Predictors of Persistent Post-surgical Pain (PPSP)

Acronym: FlexCAPP

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 19, 2015
Registry last updated
Jan 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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