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

NCT01863342 | Unknown

• 1 other identifier: 4-2013-0127
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis

Keywords

central sensitization; osteoarthritis; epidural analgesia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

CSI score < 40

CSI cutoff value\<40

Procedure: CSI score < 40

Group 2: CSI score ≥ 40

CSI cutoff value≥40

Procedure: CSI score ≥ 40

Interventions

CSI score ≥ 40 PROCEDURE

Group 2: CSI score ≥ 40

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

osteoarthritis patients undergoing total knee replacement

You may qualify if:

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

You may not qualify if:

• refusal
• coagulopathy
• neurologic deficit
• preoperative opioids medication
• recent analgesics change

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, Seoul, 120-752, South Korea

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Shin Hyung Kim, MD

CONTACT

82-2-2227-3556; tessar@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2013
• First Posted: May 27, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 27, 2013

Record last verified: 2013-05

Locations

KR (1)