NCT02340052

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
501

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 16, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

January 27, 2017

Status Verified

January 1, 2017

Enrollment Period

2.1 years

First QC Date

January 13, 2015

Last Update Submit

January 26, 2017

Conditions

Keywords

postoperative pain treatment

Outcome Measures

Primary Outcomes (2)

  • NRS pain during mobilization

    6 hours postoperatively

  • Total morphine-eqv. opioid consumption

    24 hours postoperatively

Secondary Outcomes (11)

  • NRS pain at rest

    6 hours postoperatively

  • NRS pain at rest

    24 hours postoperatively

  • NRS pain during mobilization

    24 hours postoperatively

  • Nausea

    6 hours postoperatively

  • Nausea

    24 hours postoperatively

  • +6 more secondary outcomes

Study Arms (5)

Frederiksberg Hospital

100 patients undergoing planned total hil arthroplasty

Drug: Pain treatment

Koege hospital

100 patients undergoing planned total hil arthroplasty

Drug: Pain treatment

Naestved Hospital

100 patients undergoing planned total hil arthroplasty

Drug: Pain treatment

Hilleroed Hospital

100 patients undergoing planned total hil arthroplasty

Drug: Pain treatment

Nykoebing Falster Hospital

100 patients undergoing planned total hil arthroplasty

Drug: Pain treatment

Interventions

Registration af actual analgesic treatment and outcomes

Frederiksberg HospitalHilleroed HospitalKoege hospitalNaestved HospitalNykoebing Falster Hospital

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Total hip arthroplasty patients

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Frederiksberg hospital

Frederiksberg, Sealand, 2000, Denmark

Location

Koege hospital

Koege, Sealand, 4600, Denmark

Location

Naestved hospital

Næstved, Sealand, 4700, Denmark

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Analgesia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

  • Ole Mathiesen, MD. PhD

    Head of research, department of anaesthesiology, Koege hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RCCN

Study Record Dates

First Submitted

January 13, 2015

First Posted

January 16, 2015

Study Start

April 1, 2014

Primary Completion

May 1, 2016

Study Completion

June 1, 2016

Last Updated

January 27, 2017

Record last verified: 2017-01

Locations