Postoperative PainNCT02340052
Pain Map DK: a Prospective Cohort Study of Pain Treatment in 500 Hip Arthroplasty Patients at Different Danish Hospitals
An observational study of Postoperative Pain, run by Zealand University Hospital at 3 sites in Denmark.
Trial summary
This is a prospective observational cohorte study. The aim is to investigate actual pain treatment and outcomes in a large population of total hip arthroplasty patients at 5 different hospitals in Denmark. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Pain treatment
- How many people
- 501 participants
- Where
- 3 sitesDenmark
- Study dates
- Apr 2014to 1 Jun 2016
- 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: Total hip arthroplasty patients
Who may be able to join
- Primary planned total hip arthroplasty, Able to understand and speak english or danish.
Who cannot join
- patients not able to cooperate, patients with alcohol or drug abuse
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Frederiksberg hospital
Frederiksberg, Sealand, 2000
Koege hospital
Koege, Sealand, 4600
Naestved hospital
Næstved, Sealand, 4700
About this study
This is a prospective observational cohorte study. The aim is to investigate actual pain treatment and outcomes in a large population of total hip arthroplasty patients at 5 different hospitals in Denmark.
- Conditions
- Postoperative Pain
- Being tested
- Pain treatment
- Keywords
- postoperative pain treatment
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain treatmentDrug
Registration af actual analgesic treatment and outcomes
| Study group | Role | What they receive |
|---|---|---|
| Frederiksberg Hospital | 100 patients undergoing planned total hil arthroplasty Receives: Drug: Pain treatment | |
| Koege hospital | 100 patients undergoing planned total hil arthroplasty Receives: Drug: Pain treatment | |
| Naestved Hospital | 100 patients undergoing planned total hil arthroplasty Receives: Drug: Pain treatment | |
| Hilleroed Hospital | 100 patients undergoing planned total hil arthroplasty Receives: Drug: Pain treatment | |
| Nykoebing Falster Hospital | 100 patients undergoing planned total hil arthroplasty Receives: Drug: Pain treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS pain during mobilization
Measured: 6 hours postoperatively
Total morphine-eqv. opioid consumption
Measured: 24 hours postoperatively
Secondary outcomes (11)
NRS pain at rest
Measured: 6 hours postoperatively
NRS pain at rest
Measured: 24 hours postoperatively
NRS pain during mobilization
Measured: 24 hours postoperatively
Nausea
Measured: 6 hours postoperatively
Nausea
Measured: 24 hours postoperatively
Vomiting
Measured: Number of episodes during 24 hours postoperatively
Dizziness
Measured: 6 hours postoperatively
Dizziness
Measured: 24 hours postoperatively
Sedation
Measured: 6 hours postoperatively
Sedation
Measured: 24 hours postoperatively
Length of hospital stay
Measured: Number of days until discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2015 (estimated)
- Study startApr 2014
- Primary completionMay 2016
- Study completion1 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- 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
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anja Geisler, Zealand University Hospital
- Investigators
- Ole Mathiesen, MD. PhD, Study chair, Head of research, department of anaesthesiology, Koege hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02340052
- Sponsor's protocol ID
- SM1-AG-2014
- Status last verified
- Jan 2017
- First submitted
- 13 Jan 2015
- Last updated
- 27 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Geisler A, Dahl JB, Thybo KH, Pedersen TH, Jorgensen ML, Hansen D, Schulze LK, Persson EI, Mathiesen O. Pain management after total hip arthroplasty at five different Danish hospitals: A prospective, observational cohort study of 501 patients. Acta Anaesthesiol Scand. 2019 Aug;63(7):923-930. doi: 10.1111/aas.13349. Epub 2019 Mar 18.
PubMed 30883668
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Map DK: a Prospective Cohort Study of Pain Treatment in 500 Hip Arthroplasty Patients at Different Danish Hospitals
- ClinicalTrials.gov ID
- NCT02340052
- Acronym / sponsor ID
- SM1-AG-2014
- Conditions
- Postoperative Pain
- Keywords
- postoperative pain treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- May 2016 (actual)
- Study completion
- 1 Jun 2016 (actual)
- First posted
- 16 Jan 2015 (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.
This is a prospective observational cohorte study. The aim is to investigate actual pain treatment and outcomes in a large population of total hip arthroplasty patients at 5 different hospitals in Denmark.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Frederiksberg Hospital | – | Drug: Pain treatment100 patients undergoing planned total hil arthroplasty |
| Koege hospital | – | Drug: Pain treatment100 patients undergoing planned total hil arthroplasty |
| Naestved Hospital | – | Drug: Pain treatment100 patients undergoing planned total hil arthroplasty |
| Hilleroed Hospital | – | Drug: Pain treatment100 patients undergoing planned total hil arthroplasty |
| Nykoebing Falster Hospital | – | Drug: Pain treatment100 patients undergoing planned total hil arthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Total hip arthroplasty patients
Key inclusion criteria (1 listed)
- Primary planned total hip arthroplasty, Able to understand and speak english or danish.
Key exclusion criteria (1 listed)
- patients not able to cooperate, patients with alcohol or drug abuse
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 |
|---|---|---|
| Pain treatmentRegistration af actual analgesic treatment and outcomes | Drug | Frederiksberg Hospital, Hilleroed Hospital, Koege hospital, Naestved Hospital, Nykoebing Falster Hospital |
Primary outcome
NRS pain during mobilization
Time frame: 6 hours postoperatively
Total morphine-eqv. opioid consumption
Time frame: 24 hours postoperatively
11 secondary outcomes
NRS pain at rest
Time frame: 6 hours postoperatively
NRS pain at rest
Time frame: 24 hours postoperatively
NRS pain during mobilization
Time frame: 24 hours postoperatively
Nausea
Time frame: 6 hours postoperatively
Nausea
Time frame: 24 hours postoperatively
Vomiting
Time frame: Number of episodes during 24 hours postoperatively
Dizziness
Time frame: 6 hours postoperatively
Dizziness
Time frame: 24 hours postoperatively
Sedation
Time frame: 6 hours postoperatively
Sedation
Time frame: 24 hours postoperatively
Length of hospital stay
Time frame: Number of days until discharge
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 27 Jan 2017.
- Derived from this study: PubMed 30883668Geisler A, Dahl JB, Thybo KH, Pedersen TH, Jorgensen ML, Hansen D, Schulze LK, Persson EI, Mathiesen O. Pain management after total hip arthroplasty at five different Danish hospitals: A prospective, observational cohort study of 501 patients. Acta Anaesthesiol Scand. 2019 Aug;63(7):923-930. doi: 10.1111/aas.13349. Epub 2019 Mar 18.
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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.
Ole Mathiesen, MD. PhD study chair
Head of research, department of anaesthesiology, Koege hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, run by Zealand University Hospital at 3 sites 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 1 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 27 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
NRS pain during mobilization (time frame: 6 hours postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02340052, which also lists 1 linked publication.
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 27 Jan 2017.