Prediction of Pain After Total Knee Arthroplasty

Knee Osteoarthritis Clinical Trial

Official title:

Prospective Descriptive Study of Nociceptive and Psychological Prediction of Pain After Total Knee Arthroplasty (TKA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02254499
• Other study ID #: H-3-2014-090
• Status: Completed
• Phase: N/A
• First received: September 29, 2014
• Last updated: September 22, 2015
• Start date: September 2014
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial Summary

Despite improvements in treatment, a significant part of patients have severe pain following knee arthroplasty. Preoperative identification of high-risk patients would allow for an intensive individualized analgesic treatment pre- and postoperatively and thus potentially in reduced pain acute and chronically.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• primary unilateral TKA

• caucasian

• 50 - 80 years

• osteoarthritis

Exclusion Criteria:

• deficient written or spoken danish

• impairment from psychological og neurological disease

• expected discharged to rehabilitation facility

• anticoagulant therapy

• allergies to analgesic treatment

• hypertension (systolic > 160 / diastolic > 100)

• ASA class = 4

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis, Knee

Locations

Country	Name	City	State
Denmark	Gentofte Hospital	Hellerup

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Lundbeck Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Pain intensity on a NRS from 0 to 10 upon ambulation 24 hours following surgery	24 hours postoperatively	No
Secondary	Pain	Pain intensity on a NRS (numeric rank scale) from 0 to 10 upon ambulation 48 hours following surgery	48 hours postoperatively	No
Secondary	Pain	Daily diary reported pain intensity on a NRS (numeric rank scale) from 0 to 10 in average and when worse the first two weeks following knee arthroplasty.	From day 1 to day 14 following surgery	No