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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02571400




Registration number
NCT02571400
Ethics application status
Date submitted
5/10/2015
Date registered
8/10/2015

Titles & IDs
Public title
Prevalence and Predictors of Prolonged Post-surgical Opioid Use: a Prospective Observational Cohort Study
Scientific title
Prevalence and Predictors of Prolonged Post-surgical Opioid Use: a Prospective Observational Cohort Study
Secondary ID [1] 0 0
UNDAustralia
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Opioid Use Disorders 0 0
Opioid-related Disorders 0 0
Surgery 0 0
Pain, Postoperative 0 0
Post-operative Complications 0 0
Opiate Addiction 0 0
Condition category
Condition code
Surgery 0 0 0 0
Other surgery
Mental Health 0 0 0 0
Addiction

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Continued use of opioid analgesics >90 days post-surgery

Patients scheduled to undergo surgery - Patients scheduled to undergo surgery at St Vincent's Private Hospital Sydney


Other interventions: Continued use of opioid analgesics >90 days post-surgery
Exposure of interest: continued use of opioid analgesics \>90 days post-surgery
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Continued opioid use
Timepoint [1] 0 0
90 days post-surgery
Secondary outcome [1] 0 0
Pain scores (score/10)
Timepoint [1] 0 0
90 days post-surgery
Secondary outcome [2] 0 0
Presence of pre-operative potential predictors of delayed opioid cessation
Timepoint [2] 0 0
90 days post-surgery

Eligibility
Key inclusion criteria
* Age =18 years
* Able to give written informed consent
* Willing to participate and comply with the study
* Scheduled to undergo surgery at St Vincent's Private Hospital, and attending the pre-admission clinic or day surgery unit
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Opioid tolerant patients (patients who are chronically receiving opioid analgesics on a daily basis)
* Scheduled to undergo surgery relating to malignancy
* Surgical procedures completed under local anaesthetic
* Minimally invasive procedures including gastroscopy, colonoscopy, bronchoscopy, cardioversion or transoesophageal echo
* Patients who were unable to complete study questionnaires due to psychological illness, medical condition or significant language barrier were excluded from the study.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2016
Sample size
Target
Accrual to date
Final
1013
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St Vincent's Private Hospital, Sydney - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
University of Notre Dame Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
St Vincent's Hospital, Sydney
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jennifer A Stevens, MBChB
Address 0 0
St Vincent's Hospital, Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02571400