Central Sensitization and Alteration of Circulating Neurosteroid

October 20, 2020 updated by: Jin-Woo Park, Seoul National University Bundang Hospital

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

69

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 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.
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.
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;
At 24h and 48h after the operation, for each stage of the operation.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic usage (PCA)
Time Frame: At 24h and 48h after the operation, for each stage of the operation.
Fentanyl usage with PCA
At 24h and 48h after the operation, for each stage of the operation.
Analgesic usage (rescue)
Time Frame: At 24h and 48h after the operation, for each stage of the operation.
The number of rescue analgesics treatments
At 24h and 48h after the operation, for each stage of the operation.
Antiemetic usage
Time Frame: At 24h and 48h after the operation, for each stage of the operation.
The number of antiemetics treatments
At 24h and 48h after the operation, for each stage of the operation.
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
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.
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
At the morning of operation day, for each stage of the operation
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
At the morning of operation day, for each stage of the operation
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
At the morning of operation day, for each stage of the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 20, 2017

Primary Completion (ACTUAL)

May 6, 2020

Study Completion (ACTUAL)

May 6, 2020

Study Registration Dates

First Submitted

September 22, 2017

First Submitted That Met QC Criteria

September 26, 2017

First Posted (ACTUAL)

October 2, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 20, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-1709-423-308

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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