Prevalence and Predictors of Prolonged Post-surgical Opioid Use: a Prospective Observational Cohort Study

NCT02571400 | Completed

• 1 other identifier: UNDAustralia
• Study Type: observational
• Target: 1,013
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use Disorders; Opioid-related Disorders; Surgery; Pain, Postoperative; Post-operative Complications; Opiate Addiction

Keywords

Risk; Opioid analgesics; Opioid-related disorders; Surgery; Post-operative care; Post-operative period; Post-operative complications; Opioid Use disorders; Pain, post-operative; Opiate Addiction

Outcome Measures

Primary Outcomes (1)

• 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.

  90 days post-surgery

Secondary Outcomes (2)

• Pain scores (score/10)

  90 days post-surgery

• Presence of pre-operative potential predictors of delayed opioid cessation

  90 days post-surgery

Study Arms (1)

Patients scheduled to undergo surgery

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

Other: Continued use of opioid analgesics >90 days post-surgery

Interventions

Continued use of opioid analgesics >90 days post-surgery OTHER

Exposure of interest: continued use of opioid analgesics \>90 days post-surgery

Patients scheduled to undergo surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pre-Admission Clinic, St Vincent's Private Hospital (pre-operative assessment unit) Day Surgery Unit, St Vincent's Private Hospital

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Notre Dame Australia: lead
• St Vincent's Hospital, Sydney: collaborator

Study Sites (1)

St Vincent's Private Hospital, Sydney

Sydney, New South Wales, 2010, Australia

Location

Related Publications (13)

• 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.

  PMID: 25845470 BACKGROUND

• 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.

  PMID: 19187889 BACKGROUND

• 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.

  PMID: 24964916 BACKGROUND

• 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.

  PMID: 23157942 BACKGROUND

• 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.

  PMID: 24459220 BACKGROUND

• 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.

  PMID: 22729963 BACKGROUND

• 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.

  PMID: 20462458 BACKGROUND

• 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.

  PMID: 27400458 BACKGROUND

• 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. doi: 10.1177/0310057X1404200504.

  PMID: 25233168 BACKGROUND

• 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.

  PMID: 22412106 BACKGROUND

• 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.

  PMID: 24519537 BACKGROUND

• 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):1259-1265. doi: 10.1097/j.pain.0000000000000516.

  PMID: 26871536 BACKGROUND

• 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. doi: 10.1097/j.pain.0000000000000730.

  PMID: 27984526 BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders; Pain, Postoperative

Interventions

Postoperative Period

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Perioperative Period; Surgical Procedures, Operative; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jennifer A Stevens, MBChB

  St Vincent's Hospital, Sydney

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical student

Study Record Dates

• First Submitted: October 5, 2015
• First Posted: October 8, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: May 10, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)