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Central Sensitization and Alteration of Circulating Neurosteroid

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03298711
Enrollment
69
Registered
2017-10-02
Start date
2017-11-20
Completion date
2020-05-06
Last updated
2020-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty, Replacement, Knee, Pain, Postoperative

Keywords

Central Nervous System Sensitization, Neuropeptides

Brief summary

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.

Interventions

None listed

Sponsors

Seoul National University Bundang Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
No minimum to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The profiles of cortisol in the salivaFrom 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.
The profiles of DHEA in the salivaFrom 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.
Post operative knee painAt 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

MeasureTime frameDescription
Diurnal slopeFrom 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
CARiAt the morning of operation day, for each stage of the operationnet increases in cortisol levels within the first 30 min after awakening
Analgesic usage (PCA)At 24h and 48h after the operation, for each stage of the operation.Fentanyl usage with PCA
DaucawkAt the morning of operation day, for each stage of the operationDHEA secretion area under the curve with respect to ground from the time point immediately after waking to 60 min after waking
CARaucAt the morning of operation day, for each stage of the operationcortisol secretion area under the curve with respect to ground from the time point immediately after waking to 60 min after waking
Analgesic usage (rescue)At 24h and 48h after the operation, for each stage of the operation.The number of rescue analgesics treatments
Antiemetic usageAt 24h and 48h after the operation, for each stage of the operation.The number of antiemetics treatments

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026