Clinical trial NCT03298711: Central Sensitization and Alteration of Circulating Neurosteroid
Official title: Relationship Between Central Sensitization and Alteration of Circulating Neurosteroid Following Bilateral Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthroplasty, Replacement, Knee
Pain, Postoperative
Keywords: Central Nervous System Sensitization
Neuropeptides
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2017-10-02
Enrollment: 69
Sex: FEMALE
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who visit Seoul National University Bundang Hospital for two-staged bilateral total knee arthroplasty.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The profiles of cortisol in the saliva
timeFrame: 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.
measure: The profiles of DHEA in the saliva
timeFrame: 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.
measure: Post operative knee pain
timeFrame: At 24h and 48h after the operation, for each stage of the operation.
Secondary outcomes:
measure: Analgesic usage (PCA)
timeFrame: At 24h and 48h after the operation, for each stage of the operation.
measure: Analgesic usage (rescue)
timeFrame: At 24h and 48h after the operation, for each stage of the operation.
measure: Antiemetic usage
timeFrame: At 24h and 48h after the operation, for each stage of the operation.
measure: Diurnal slope
timeFrame: 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.
measure: CARi
timeFrame: At the morning of operation day, for each stage of the operation
measure: CARauc
timeFrame: At the morning of operation day, for each stage of the operation
measure: Daucawk
timeFrame: At the morning of operation day, for each stage of the operation
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jin-Woo Park, MD
role: PRINCIPAL_INVESTIGATOR
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citation: Jo KB, Lee YJ, Lee IG, Lee SC, Park JY, Ahn RS. Association of pain intensity, pain-related disability, and depression with hypothalamus-pituitary-adrenal axis function in female patients with chronic temporomandibular disorders. Psychoneuroendocrinology. 2016 Jul;69:106-15. doi: 10.1016/j.psyneuen.2016.03.017. Epub 2016 Mar 31.
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