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Completed

NCT Number: NCT03298711

Central Sensitization and Alteration of Circulating Neurosteroid

For patients who underwent two-stage replacement of both knee joints (one knee surgery - one week term- the other knee surgery), postoperative pain and analgesic usage with patient-controlled analgesia (PCA) increased at the second stage, which suggests that central sensitization occurs within a short period (one week) in patients who undergo total knee arthroplasty (TKA). Neurosteroids act on NMDA and AMPA receptors, GABAa receptors, and voltage-dependent Ca2+ or K+ channels of sensory neurons to increase invasive or neuropathic pain and, conversely, to exhibit analgesic and anticonvulsant effects. These actions mean that the neurosteroid acts as an endogenous regulator of pain control and central sensitization. The purpose of this study is to confirm that the hypothalamus-pituitary-adrenal (HPA) axis, which is the main body of endocrine neurosteroid, is associated with increased pain sensitivity after TKA. The concentrations of cortisol and dehydroepiandrosterone (DHEA) in the saliva of patients who undergo two-staged bilateral knee replacement surgery (one knee surgery - one week term- the other knee surgery) will be measured at each stage and analyzed for correlation between concentration-related changes of HPA and postoperative knee pain variations.

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Key information

Age range

Up to 70 year

Sex eligibility

Female

Study type

Observational

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Two-staged bilateral total knee arthroplasty (one knee - one week - the other knee)
  • American Society of Anesthesiologists (ASA) class I, II
  • Postmenopausal women aged under 71

Exclusion criteria

  • Patients who have used analgesics before surgery, such as chronic pain patients
  • ≥ ASA class III, including patients with renal impairment or symptomatic cardiovascular disease
  • Patients who refuse to participate in the study or from whom receive informed consent cannot be received.

Treatment and study plan

Primary outcomes

  1. The profiles of cortisol in the saliva

    Time frame: From the evening (9PM) before the operation day to the morning (60 minutes after the wake-up) of the operation day, for each stage of the operation.

    The cortisol concentrations in the saliva, at the evening before the operation (21:00-22:00), just after wake-up in the morning of operation day, and 30 and 60 minutes after the wake-up.

  2. The profiles of DHEA in the saliva

    Time frame: From the evening (9PM) before the operation day to the morning (60 minutes after the wake-up) of the operation day, for each stage of the operation.

    The DHEA concentrations in the saliva, at the evening before the operation (21:00-22:00), just after wake-up in the morning of operation day, and 30 and 60 minutes after the wake-up.

  3. Post operative knee pain

    Time frame: At 24h and 48h after the operation, for each stage of the operation.

    At rest and at maximum knee flexion, visual analogue scale (VAS) score of knee pain;

Secondary outcomes

  1. Analgesic usage (PCA)

    Time frame: At 24h and 48h after the operation, for each stage of the operation.

    Fentanyl usage with PCA

  2. Analgesic usage (rescue)

    Time frame: At 24h and 48h after the operation, for each stage of the operation.

    The number of rescue analgesics treatments

  3. Antiemetic usage

    Time frame: At 24h and 48h after the operation, for each stage of the operation.

    The number of antiemetics treatments

  4. Diurnal slope

    Time frame: From the evening (9PM) before the operation day to the morning (60 minutes after the wake-up) of the operation day, for each stage of the operation.

    slope for diurnal cortisol decline from the time point immediately upon awakening to nighttime

  5. CARi

    Time frame: At the morning of operation day, for each stage of the operation

    net increases in cortisol levels within the first 30 min after awakening

  6. CARauc

    Time frame: At the morning of operation day, for each stage of the operation

    cortisol secretion area under the curve with respect to ground from the time point immediately after waking to 60 min after waking

  7. Daucawk

    Time frame: At the morning of operation day, for each stage of the operation

    DHEA secretion area under the curve with respect to ground from the time point immediately after waking to 60 min after waking

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

Relationship Between Central Sensitization and Alteration of Circulating Neurosteroid Following Bilateral Total Knee Arthroplasty

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Oct 2, 2017
Registry last updated
Oct 22, 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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