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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02340052
Other study ID # SM1-AG-2014
Secondary ID
Status Completed
Phase N/A
First received January 13, 2015
Last updated January 26, 2017
Start date April 2014
Est. completion date June 1, 2016

Study information

Verified date January 2017
Source Zealand University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 501
Est. completion date June 1, 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Pain treatment
Registration af actual analgesic treatment and outcomes

Locations

Country Name City State
Denmark Frederiksberg hospital Frederiksberg Sealand
Denmark Koege hospital Koege Sealand
Denmark Naestved hospital Naestved Sealand

Sponsors (1)

Lead Sponsor Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary NRS pain during mobilization 6 hours postoperatively
Primary Total morphine-eqv. opioid consumption 24 hours postoperatively
Secondary NRS pain at rest 6 hours postoperatively
Secondary NRS pain at rest 24 hours postoperatively
Secondary NRS pain during mobilization 24 hours postoperatively
Secondary Nausea 6 hours postoperatively
Secondary Nausea 24 hours postoperatively
Secondary Vomiting Number of episodes during 24 hours postoperatively
Secondary Dizziness 6 hours postoperatively
Secondary Dizziness 24 hours postoperatively
Secondary Sedation 6 hours postoperatively
Secondary Sedation 24 hours postoperatively
Secondary Length of hospital stay Number of days until discharge
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