Influence of Central Sensitization on Efficacy of Patient-controlled Epidural Analgesia in Osteoarthritis Patients Undergoing Total Knee Replacement

Knee Osteoarthritis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01863342
• Other study ID #: 4-2013-0127
• Status: Recruiting
• Phase: N/A
• First received: May 22, 2013
• Last updated: May 22, 2013
• Start date: May 2013
• Est. completion date: May 2014

Study information

• Verified date: May 2013
• Source: Yonsei University
• Contact: Shin Hyung Kim, MD
• Phone: 82-2-2227-3556
• Email: tessar[@]yuhs.ac
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Nociceptor inputs can trigger a prolonged but reversible increase in the excitability and synaptic efficacy of neurons in central nociceptive pathways, the phenomenon of central sensitization. The degenerative joint disease, osteoarthritis, with characteristic destruction of cartilage and alteration in bone is a very common cause of chronic pain. The degree of pain does not always correlate with the extent of joint damage or presence of active inflammation raising the possibility that there may be a central component to the pain. The central sensitization inventory (CSI) is a new self-report screening instrument to measure the degree of central sensitization, and to help identify patients with central sensitivity syndromes. The aim of this investigation is to evaluate the influence of preoperative central sensitization, which represented by CSI score, on postoperative pain score in osteoarthritis patients undergoing total knee replacement who receiving patient-controlled epidural analgesia.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Aged 20 to 80 years osteoarthritis patients undergoing total knee replacement under spinal anesthesia, and who receiving postoperative epidural PCA

Exclusion Criteria:

• refusal

• coagulopathy

• neurologic deficit

• preoperative opioids medication

• recent analgesics change

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• CSI score < 40

• CSI score = 40

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak pain score	Numeric rating scale (0 to 10 points) at each assessment interval	at the point of Epidural PCA to postoperative 1-48 h	No