Central Sensitization and Alteration of Circulating Neurosteroid

Completed

• Conditions: Pain, Postoperative; Arthroplasty, Replacement, Knee

• Registration Number: NCT03298711
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-22
• Study First Submitted QC: 2017-09-26
• Study First Posted: 2017-10-02
• Study Start: 2017-11-20
• Primary Completion: 2020-05-06
• Study Completion: 2020-05-06
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-20
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 69

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The profiles of cortisol in the saliva	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.
The profiles of DHEA in the saliva	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.
Post operative knee pain	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 Outcome Measures

Name	Time	Method
Antiemetic usage	At 24h and 48h after the operation, for each stage of the operation.	The number of antiemetics treatments
CARauc	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
Analgesic usage (PCA)	At 24h and 48h after the operation, for each stage of the operation.	Fentanyl usage with PCA
Analgesic usage (rescue)	At 24h and 48h after the operation, for each stage of the operation.	The number of rescue analgesics treatments
Diurnal slope	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
Daucawk	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
CARi	At the morning of operation day, for each stage of the operation	net increases in cortisol levels within the first 30 min after awakening

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of