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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02571400
Ethics application status
Date submitted
5/10/2015
Date registered
8/10/2015
Date last updated
10/05/2017

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 - Subjects will be recruited to the study from October 2015 to March 2016, prior to their elective surgical procedure. All subjects will be contacted by investigators at 90 days post-surgery. At this point, they will be asked questions regarding their current analgesic use. This will enable us to calculate the prevalence of continued opioid use at =90 days post-surgery. Data collection will be complete by June 2016.
Timepoint [1] 0 0
90 days post-surgery
Secondary outcome [1] 0 0
Pain scores (score/10) - Subjects will be recruited to the study from October 2015 to March 2016, prior to their elective surgical procedure. All subjects will be contacted by investigators at 90 days post-surgery. At this point, they will be asked questions regarding their current pain scores out of 10. Data collection will be complete by June 2016.
Timepoint [1] 0 0
90 days post-surgery
Secondary outcome [2] 0 0
Presence of pre-operative potential predictors of delayed opioid cessation - Subjects will be recruited to the study from October 2015 to March 2016, prior to their elective surgical procedure. Subjects will complete a single questionnaire prior to surgery which will collect data including their age, sex, operation type, pre-operative opioid use, depression traits, anxiety traits, addictive traits, perceived susceptibility to addiction, average hours of sleep per night, history of chronic pain, and perceived general health.
The investigators will compare subjects with and without delayed opioid cessation to see which questionnaire items were able to independently predict continued opioid use >90 days post-surgery. Data collection will be complete by June 2016.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Post-surgical opioid prescribing intended for the short-term management of acute pain may
lead to long-term opioid use, and its associated harms. This study was undertaken to
determine the prevalence of prolonged post-surgical opioid use, and patient-related factors
associated with prolonged post-surgical opioid use.
Trial website
https://clinicaltrials.gov/show/NCT02571400
Trial related presentations / publications
Hollingworth SA, Gray PD, Hall WD, Najman JM. Opioid analgesic prescribing in Australia: a focus on gender and age. Pharmacoepidemiol Drug Saf. 2015 Jun;24(6):628-36. doi: 10.1002/pds.3767. Epub 2015 Apr 1.
Chou R, Fanciullo GJ, Fine PG, Adler JA, Ballantyne JC, Davies P, Donovan MI, Fishbain DA, Foley KM, Fudin J, Gilson AM, Kelter A, Mauskop A, O'Connor PG, Passik SD, Pasternak GW, Portenoy RK, Rich BA, Roberts RG, Todd KH, Miaskowski C; American Pain Society-American Academy of Pain Medicine Opioids Guidelines Panel. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain. 2009 Feb;10(2):113-30. doi: 10.1016/j.jpain.2008.10.008.
Hah JM, Mackey S, Barelka PL, Wang CK, Wang BM, Gillespie MJ, McCue R, Younger JW, Trafton J, Humphreys K, Goodman SB, Dirbas FM, Schmidt PC, Carroll IR. Self-loathing aspects of depression reduce postoperative opioid cessation rate. Pain Med. 2014 Jun;15(6):954-64. doi: 10.1111/pme.12439.
Singh JA, Lewallen DG. Predictors of use of pain medications for persistent knee pain after primary Total Knee Arthroplasty: a cohort study using an institutional joint registry. Arthritis Res Ther. 2012 Nov 16;14(6):R248. doi: 10.1186/ar4091.
Singh JA, Lewallen DG. Predictors of pain medication use for arthroplasty pain after revision total knee arthroplasty. Rheumatology (Oxford). 2014 Oct;53(10):1752-8. doi: 10.1093/rheumatology/ket443. Epub 2014 Jan 22.
Carroll I, Barelka P, Wang CK, Wang BM, Gillespie MJ, McCue R, Younger JW, Trafton J, Humphreys K, Goodman SB, Dirbas F, Whyte RI, Donington JS, Cannon WB, Mackey SC. A pilot cohort study of the determinants of longitudinal opioid use after surgery. Anesth Analg. 2012 Sep;115(3):694-702. doi: 10.1213/ANE.0b013e31825c049f. Epub 2012 Jun 22.
Singh JA, Lewallen D. Predictors of pain and use of pain medications following primary Total Hip Arthroplasty (THA): 5,707 THAs at 2-years and 3,289 THAs at 5-years. BMC Musculoskelet Disord. 2010 May 13;11:90. doi: 10.1186/1471-2474-11-90.
Sun EC, Darnall BD, Baker LC, Mackey S. Incidence of and Risk Factors for Chronic Opioid Use Among Opioid-Naive Patients in the Postoperative Period. JAMA Intern Med. 2016 Sep 1;176(9):1286-93. doi: 10.1001/jamainternmed.2016.3298. Erratum in: JAMA Intern Med. 2016 Sep 1;176(9):1412.
Macintyre PE, Huxtable CA, Flint SL, Dobbin MD. Costs and consequences: a review of discharge opioid prescribing for ongoing management of acute pain. Anaesth Intensive Care. 2014 Sep;42(5):558-74. Review.
Alam A, Gomes T, Zheng H, Mamdani MM, Juurlink DN, Bell CM. Long-term analgesic use after low-risk surgery: a retrospective cohort study. Arch Intern Med. 2012 Mar 12;172(5):425-30. doi: 10.1001/archinternmed.2011.1827.
Clarke H, Soneji N, Ko DT, Yun L, Wijeysundera DN. Rates and risk factors for prolonged opioid use after major surgery: population based cohort study. BMJ. 2014 Feb 11;348:g1251. doi: 10.1136/bmj.g1251.
Goesling J, Moser SE, Zaidi B, Hassett AL, Hilliard P, Hallstrom B, Clauw DJ, Brummett CM. Trends and predictors of opioid use after total knee and total hip arthroplasty. Pain. 2016 Jun;157(6):1259-65. doi: 10.1097/j.pain.0000000000000516.
Quinn PD, Hur K, Chang Z, Krebs EE, Bair MJ, Scott EL, Rickert ME, Gibbons RD, Kroenke K, D'Onofrio BM. Incident and long-term opioid therapy among patients with psychiatric conditions and medications: a national study of commercial health care claims. Pain. 2017 Jan;158(1):140-148.
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

Summary results
Other publications