Surgery Clinical Trial
Official title:
Prevalence and Predictors of Prolonged Post-surgical Opioid Use: a Prospective Observational Cohort Study
Verified date | May 2017 |
Source | University of Notre Dame Australia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1013 |
Est. completion date | October 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 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. |
Country | Name | City | State |
---|---|---|---|
Australia | St Vincent's Private Hospital, Sydney | Sydney | New South Wales |
Lead Sponsor | Collaborator |
---|---|
University of Notre Dame Australia | St Vincent's Hospital, Sydney |
Australia,
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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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | 90 days post-surgery | |
Secondary | 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. |
90 days post-surgery |
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