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

• Sponsor: Yonsei University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01863342
• Collaborator: (none)
• Enrollment: 98
• Location: 1
• Duration (Months): 12
• Patients Per Site Per Month: 8.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Procedure: CSI score < 40; Procedure: CSI score ≥ 40

Study Design

• Study Type: Observational
• Anticipated Enrollment: 98 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Study Start Date: May 1, 2013
• Anticipated Primary Completion Date: May 1, 2014
• Anticipated Study Completion Date: May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
CSI score < 40 CSI cutoff value<40	Procedure: CSI score < 40
Group 2: CSI score ≥ 40 CSI cutoff value≥40	Procedure: CSI score ≥ 40

Outcome Measures

Primary Outcome Measures

1. Peak pain score [at the point of Epidural PCA to postoperative 1-48 h]

   Numeric rating scale (0 to 10 points) at each assessment interval

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

• Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT01863342
• Other Study ID Numbers: 4-2013-0127
• First Posted: May 27, 2013
• Last Update Posted: May 27, 2013
• Last Verified: May 1, 2013

• Keywords provided by Yonsei University: central sensitization; osteoarthritis; epidural analgesia
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

No Results Posted as of May 27, 2013