Prediction of Pain in Total Hip Arthroplasty

September 25, 2012 updated by: Troels Haxholdt Lunn, Hvidovre University Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 hip arthroplasty - demographic factors, preoperative pain related factors, psychosocial factors (Hospital Anxiety and Depression Scale and Pain Catastrophizing Scale).

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Hvidovre
      • Copenhagen, Hvidovre, Denmark, 2650
        • Dep. of Anesthesiology, Hvidovre University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing total hip arthroplasty (THA)

Description

Inclusion Criteria:

  • Ethnic danes, above 18 years and able to give informed consent scheduled for primary, unilateral total hip 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
THA (total hip arthroplasty)
Patients undergoing THA, preoperatively heat tested
Device: heat pain test (Modular Sensory Analyzer, Somedic AB, Horby, Sweden).
pain during heat test preoperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain (from 0-24 hours after surgery)
Time Frame: 24 hours
Pain assessed with the visual analog scale
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain (from day 1 to day 7 after surgery)
Time Frame: 7 days
Pain assessed with the visual analog scale
7 days
Pain at day 14 after surgery
Time Frame: 14 days
Pain assessed with the visual analog scale
14 days
Pain at day 30 after surgery
Time Frame: 30 days
Pain assessed with the visual analog scale
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Investigators

  • Principal Investigator: Troels H Lunn, MD, Dep. of Anesthesiology, Hvidovre University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

March 25, 2011

First Submitted That Met QC Criteria

March 25, 2011

First Posted (Estimate)

March 29, 2011

Study Record Updates

Last Update Posted (Estimate)

September 26, 2012

Last Update Submitted That Met QC Criteria

September 25, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2-2010-052, part 2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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