Pain, PostoperativeNCT01324375
Prediction of Pain in Total Hip Arthroplasty
An observational study of Pain, Postoperative, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- heat pain test (Modular Sensory Analyzer, Somedic AB, Horby, Sweden).
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2011to Mar 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing total hip arthroplasty (THA)
Who may be able to join
- Ethnic danes, above 18 years and able to give informed consent scheduled for primary, unilateral total hip arthroplasty
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dep. of Anesthesiology, Hvidovre University Hospital
Copenhagen, Hvidovre, 2650
About this study
Official title: 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.
Read the 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).
- Conditions
- Pain, Postoperative
- Being tested
- heat pain test (Modular Sensory Analyzer, Somedic AB, Horby, Sweden).
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heat pain test (Modular Sensory Analyzer, Somedic AB, Horby, Sweden).Device
pain during heat test preoperatively
| Study group | Role | What they receive |
|---|---|---|
| THA (total hip arthroplasty) | Patients undergoing THA, preoperatively heat tested Receives: Device: heat pain test (Modular Sensory Analyzer, Somedic AB, Horby, Sweden). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (from 0-24 hours after surgery)
Pain assessed with the visual analog scale
Measured: 24 hours
Secondary outcomes (3)
Pain (from day 1 to day 7 after surgery)
Pain assessed with the visual analog scale
Measured: 7 days
Pain at day 14 after surgery
Pain assessed with the visual analog scale
Measured: 14 days
Pain at day 30 after surgery
Pain assessed with the visual analog scale
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Troels Haxholdt Lunn, Hvidovre University Hospital
- Investigators
- Troels H Lunn, MD, Principal investigator, Dep. of Anesthesiology, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01324375
- Sponsor's protocol ID
- H-2-2010-052, part 2
- Status last verified
- Sep 2012
- First submitted
- 25 Mar 2011
- Last updated
- 26 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Preoperative Pain Response Upon Tonic Heat Stimulation Predictive for Pain After Total Hip Arthroplasty?
- ClinicalTrials.gov ID
- NCT01324375
- Acronym / sponsor ID
- H-2-2010-052, part 2
- Conditions
- Pain, Postoperative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 29 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| THA (total hip arthroplasty) | – | Device: heat pain test (Modular Sensory Analyzer, Somedic AB, Horby, Sweden).Patients undergoing THA, preoperatively heat tested |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing total hip arthroplasty (THA)
Key inclusion criteria (1 listed)
- Ethnic danes, above 18 years and able to give informed consent scheduled for primary, unilateral total hip arthroplasty
Key exclusion criteria (8 listed)
- Bilateral/revision arthroplasty
- Disease affection central or peripheral nerve function
- Alcohol and medical abuse
- Daily use of opioids or glucocorticoids
- Malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| heat pain test (Modular Sensory Analyzer, Somedic AB, Horby, Sweden).pain during heat test preoperatively | Device | THA (total hip arthroplasty) |
Primary outcome
Pain (from 0-24 hours after surgery)
Time frame: 24 hours
Pain assessed with the visual analog scale
3 secondary outcomes
Pain (from day 1 to day 7 after surgery)
Time frame: 7 days
Pain at day 14 after surgery
Time frame: 14 days
Pain at day 30 after surgery
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2012.
Related trials for Pain, Postoperative
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Troels H Lunn, MD principal investigator
Dep. of Anesthesiology, Hvidovre University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (from 0-24 hours after surgery) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2012.