Pain Map DK: a Prospective Cohort Study of Pain Treatment in 500 Hip Arthroplasty Patients at Different Danish Hospitals

January 26, 2017 updated by: Anja Geisler, Zealand University Hospital
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

501

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
    • Sealand
      • Frederiksberg, Sealand, Denmark, 2000
        • Frederiksberg Hospital
      • Koege, Sealand, Denmark, 4600
        • Koege Hospital
      • Naestved, Sealand, Denmark, 4700
        • Naestved 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

Total hip arthroplasty patients

Description

Inclusion Criteria:

  • Primary planned total hip arthroplasty, Able to understand and speak english or danish.

Exclusion Criteria:

  • patients not able to cooperate, patients with alcohol or drug abuse

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Frederiksberg Hospital
100 patients undergoing planned total hil arthroplasty
Drug: Pain treatment
Registration af actual analgesic treatment and outcomes
Koege hospital
100 patients undergoing planned total hil arthroplasty
Drug: Pain treatment
Registration af actual analgesic treatment and outcomes
Naestved Hospital
100 patients undergoing planned total hil arthroplasty
Drug: Pain treatment
Registration af actual analgesic treatment and outcomes
Hilleroed Hospital
100 patients undergoing planned total hil arthroplasty
Drug: Pain treatment
Registration af actual analgesic treatment and outcomes
Nykoebing Falster Hospital
100 patients undergoing planned total hil arthroplasty
Drug: Pain treatment
Registration af actual analgesic treatment and outcomes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
NRS pain during mobilization
Time Frame: 6 hours postoperatively
6 hours postoperatively
Total morphine-eqv. opioid consumption
Time Frame: 24 hours postoperatively
24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
NRS pain at rest
Time Frame: 6 hours postoperatively
6 hours postoperatively
NRS pain at rest
Time Frame: 24 hours postoperatively
24 hours postoperatively
NRS pain during mobilization
Time Frame: 24 hours postoperatively
24 hours postoperatively
Nausea
Time Frame: 6 hours postoperatively
6 hours postoperatively
Nausea
Time Frame: 24 hours postoperatively
24 hours postoperatively
Vomiting
Time Frame: Number of episodes during 24 hours postoperatively
Number of episodes during 24 hours postoperatively
Dizziness
Time Frame: 6 hours postoperatively
6 hours postoperatively
Dizziness
Time Frame: 24 hours postoperatively
24 hours postoperatively
Sedation
Time Frame: 6 hours postoperatively
6 hours postoperatively
Sedation
Time Frame: 24 hours postoperatively
24 hours postoperatively
Length of hospital stay
Time Frame: Number of days until discharge
Number of days until discharge

Collaborators and Investigators

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

Sponsor

Zealand University Hospital

Investigators

  • Study Chair: Ole Mathiesen, MD. PhD, Head of research, department of anaesthesiology, Koege hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

January 13, 2015

First Submitted That Met QC Criteria

January 15, 2015

First Posted (Estimate)

January 16, 2015

Study Record Updates

Last Update Posted (Estimate)

January 27, 2017

Last Update Submitted That Met QC Criteria

January 26, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SM1-AG-2014

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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