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Arthroplasty, Replacement, KneeNCT03298711

Central Sensitization and Alteration of Circulating Neurosteroid

An observational study of Arthroplasty, Replacement, Knee and Pain, Postoperative, run by Seoul National University Bundang Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages Up to 70 years, women only
How many people
69 participants
Where
1 siteSouth Korea
Study dates
20 Nov 2017to 6 May 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 70 years
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients who visit Seoul National University Bundang Hospital for two-staged bilateral total knee arthroplasty.

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

Other trials in South Korea

About this study

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

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.

Keywords
Central Nervous System Sensitization, Neuropeptides
Medical subject headings
Pain, Postoperative

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The profiles of cortisol in the saliva

    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.

    Measured: 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.

  2. The profiles of DHEA in the saliva

    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.

    Measured: 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.

  3. Post operative knee pain

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

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

Secondary outcomes (7)

  1. Analgesic usage (PCA)

    Fentanyl usage with PCA

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

  2. Analgesic usage (rescue)

    The number of rescue analgesics treatments

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

  3. Antiemetic usage

    The number of antiemetics treatments

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

  4. Diurnal slope

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

    Measured: 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.

  5. CARi

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

    Measured: At the morning of operation day, for each stage of the operation

  6. CARauc

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

    Measured: At the morning of operation day, for each stage of the operation

  7. Daucawk

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

    Measured: At the morning of operation day, for each stage of the operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2017
  2. Study start20 Nov 2017
  3. Primary completion6 May 2020
  4. Study completion6 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03298711
Sponsor's protocol ID
B-1709-423-308
Status last verified
Oct 2020
First submitted
22 Sep 2017
Last updated
22 Oct 2020
Results posted
No
Individual data sharing
No

Publications

  • Losina E, Katz JN. Total knee replacement: pursuit of the paramount result. Rheumatology (Oxford). 2012 Oct;51(10):1735-6. doi: 10.1093/rheumatology/kes199. Epub 2012 Jul 28. No abstract available.

    PubMed 22843792

  • Rosseland LA, Solheim N, Stubhaug A. Pain and disability 1 year after knee arthroscopic procedures. Acta Anaesthesiol Scand. 2008 Mar;52(3):332-7. doi: 10.1111/j.1399-6576.2007.01541.x.

    PubMed 18269385

  • Harden NR, Bruehl S, Stanos S, Brander V, Chung OY, Saltz S, Adams A, Stulberg DS. Prospective examination of pain-related and psychological predictors of CRPS-like phenomena following total knee arthroplasty: a preliminary study. Pain. 2003 Dec;106(3):393-400. doi: 10.1016/j.pain.2003.08.009.

    PubMed 14659522

  • Pruessner JC, Wolf OT, Hellhammer DH, Buske-Kirschbaum A, von Auer K, Jobst S, Kaspers F, Kirschbaum C. Free cortisol levels after awakening: a reliable biological marker for the assessment of adrenocortical activity. Life Sci. 1997;61(26):2539-49. doi: 10.1016/s0024-3205(97)01008-4.

    PubMed 9416776

  • Kim MH, Nahm FS, Kim TK, Chang MJ, Do SH. Comparison of postoperative pain in the first and second knee in staged bilateral total knee arthroplasty: clinical evidence of enhanced pain sensitivity after surgical injury. Pain. 2014 Jan;155(1):22-27. doi: 10.1016/j.pain.2013.08.027. Epub 2013 Aug 30.

    PubMed 23994101

  • Shin HJ, Kim EY, Na HS, Kim TK, Kim MH, Do SH. Magnesium sulphate attenuates acute postoperative pain and increased pain intensity after surgical injury in staged bilateral total knee arthroplasty: a randomized, double-blinded, placebo-controlled trial. Br J Anaesth. 2016 Oct;117(4):497-503. doi: 10.1093/bja/aew227. Epub 2016 Oct 17.

    PubMed 28077538

  • 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.

    PubMed 27082645

  • Park JY, Ahn RS. Hypothalamic-pituitary-adrenal axis function in patients with complex regional pain syndrome type 1. Psychoneuroendocrinology. 2012 Sep;37(9):1557-68. doi: 10.1016/j.psyneuen.2012.02.016. Epub 2012 Mar 24.

    PubMed 22445364

  • Ahn RS, Park JW, Park IS, Shin HJ, Ryu JH, Oh AY, Park HY, Do SH. The Involvement of the Hypothalamus-Pituitary-Adrenal Axis in the Development of Hyperalgesia during the Early Postoperative Period. Neuroendocrinology. 2023;113(3):319-331. doi: 10.1159/000526793. Epub 2022 Aug 29.

    PubMed 36037793

Questions about this trial

What is this clinical trial studying?

An observational study of Arthroplasty, Replacement, Knee and Pain, Postoperative, run by Seoul National University Bundang Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03298711, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.

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