Prediction of Pain in Total Hip Arthroplasty
This study has been completed.
Sponsor:
Hvidovre University Hospital
Information provided by (Responsible Party):
Troels Haxholdt Lunn, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01324375
First received: March 25, 2011
Last updated: September 25, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pain, Postoperative |
Device: heat pain test (Modular Sensory Analyzer, Somedic AB, Horby, Sweden). |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Is Preoperative Pain Response Upon Tonic Heat Stimulation Predictive for Pain After Total Hip Arthroplasty? |
Further study details as provided by Hvidovre University Hospital:
Primary Outcome Measures:
- Pain (from 0-24 hours after surgery) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]Pain assessed with the visual analog scale
Secondary Outcome Measures:
- Pain (from day 1 to day 7 after surgery) [ Time Frame: 7 days ] [ Designated as safety issue: No ]Pain assessed with the visual analog scale
- Pain at day 14 after surgery [ Time Frame: 14 days ] [ Designated as safety issue: No ]Pain assessed with the visual analog scale
- Pain at day 30 after surgery [ Time Frame: 30 days ] [ Designated as safety issue: No ]Pain assessed with the visual analog scale
Biospecimen Retention: Samples With DNA
Blood samples
| Enrollment: | 60 |
| Study Start Date: | March 2011 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients undergoing total hip arthroplasty (THA)
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01324375
Locations
| Denmark | |
| Dep. of Anesthesiology, Hvidovre University Hospital | |
| Copenhagen, Hvidovre, Denmark, 2650 | |
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
| Principal Investigator: | Troels H Lunn, MD | Dep. of Anesthesiology, Hvidovre University Hospital |
More Information
No publications provided
| Responsible Party: | Troels Haxholdt Lunn, MD, Hvidovre University Hospital |
| ClinicalTrials.gov Identifier: | NCT01324375 History of Changes |
| Other Study ID Numbers: | H-2-2010-052, part 2 |
| Study First Received: | March 25, 2011 |
| Last Updated: | September 25, 2012 |
| Health Authority: | Denmark: Ethics Committee Denmark: Danish Dataprotection Agency |
Additional relevant MeSH terms:
|
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013