Prediction of Pain in Total Knee Arthroplasty

Pain, Postoperative Clinical Trial

Official title:

Is Preoperative Pain Response Upon Tonic Heat Stimulation Predictive for Pain After Total Knee Arthroplasty?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01179204
• Other study ID #: H-2-2010-052
• Status: Completed
• Phase: N/A
• First received: August 9, 2010
• Last updated: September 25, 2012
• Start date: August 2010
• Est. completion date: September 2011

Study information

• Verified date: September 2012
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial Summary

In this consecutive, prospective cohort study trial the investigators evaluate if preoperative pain response upon heat stimulation is predictive for acute and subacute postoperative pain after total knee arthroplasty.

Description:

The preoperative heat stimulation consists of short and long tonic heat stimulation. Pain response is evaluated with an electronic visual analog scale.

Furthermore the investigators evaluate other factors possibly predictable for acute and subacute postoperative pain after total knee arthroplasty - demographic factors, preoperative pain related factors, psychosocial factors (Hospital Anxiety and Depression Scale and Pain Catastrophizing Scale).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ethnic danes, above 18 years and able to give informed consent scheduled for primary, unilateral total knee arthroplasty.

Exclusion Criteria:

• Bilateral / revision arthroplasty

• Disease affection central or peripheral nerve function

• Alcohol and medical abuse

• Daily use of opioids or glucocorticoids

• Malignancy

• BMI > 40

• Depression

• Dementia or other cognitive dysfunction

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Procedure:
• Preoperative heat stimulation
Preoperative short and long tonic heat stimulation

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Copenhagen	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulated pain (from 0-24 hours after surgery)	Pain during walk 5 m (VAS)	24 hours	No
Secondary	Cumulated pain (from day 1 to day 7 after surgery)		7 days	No
Secondary	Pain at day 14 after surgery		14 days	No
Secondary	Pain at day 30 after surgery		30 days	Yes