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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02571400
Recruitment Status : Completed
First Posted : October 8, 2015
Last Update Posted : May 10, 2017
Sponsor:
Collaborator:
St Vincent's Hospital, Sydney
Information provided by (Responsible Party):
Natasha Stark, University of Notre Dame Australia

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.

Condition or disease Intervention/treatment
Opioid Use Disorders Opioid-related Disorders Surgery Pain, Postoperative Post-operative Complications Opiate Addiction Other: Continued use of opioid analgesics >90 days post-surgery

Detailed Description:

There are growing concerns that surgery is a risk factor for chronic opioid use. Existing studies suggest that post-surgical opioid prescribing intended for the short-term management of acute pain may result in unintended long-term opioid use for a small, but meaningful number of patients.

Increasing numbers of patients are discharged from hospital post-surgery with opioids for the management of their acute post-surgical pain. Opioids have proven efficacy for the management of acute post-surgical pain, but can cause significant harm when used long-term for non-cancer pain. Evidence suggests that post-surgical opioid use continues in some patients for years after surgery.

Identification of patients at risk of prolonged opioid use after surgery may assist in reducing the adverse outcomes associated with long-term opioid use. Pre-operative risk stratification tools may be of use in identifying surgical patients at risk of long-term opioid use. Validated tools are widely used to identify patients at high risk of opioid misuse in the chronic pain setting, but currently there is no optimal method to predict patients at risk of chronic opioid use after surgery.

Existing studies have found that a wide range of patient characteristics and psychiatric comorbidities are associated with long-term opioid use in a post-surgical setting.

There are 5 primary study procedures in the investigators research project:

  1. Enrolment in the study: Subjects will be recruited and enrolled at the pre-operative admission clinic and day surgery unit at St Vincent's Private Hospital, Sydney. This study aims to enrol 1000 patients.
  2. Informed consent: Patients who meet inclusion criteria, and agree to enrol in the study will be asked to read and sign an informed consent document.
  3. Initial questionnaire: Trained nursing staff will administer an initial questionnaire to all patients participating in the study. This questionnaire will gather data regarding potential predictors of delayed opiate cessation including 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.
  4. Follow-up questionnaire: At approximately 90 days post-surgery, a follow-up questionnaire will be administered to all enrolled subjects via phone call or email. This questionnaire will determine current pain scores and details regarding current pain medication usage.
  5. Statistical analysis: Once data collection is complete, identifying details will be removed, and data will be entered into a password-protected electronic database. The investigators will analyse data from all patients and determine the prevalence of delayed opioid cessation, and which questionnaire items independently predict delayed opioid cessation.

The investigators primary study objective is to determine the prevalence of prolonged post-surgical opioid use, defined by our study as patients taking opioids >90 days post-surgery. The investigators secondary objective is to identify patient-related factors that are independently associated with prolonged post-surgical opioid use. These factors may be used to develop a pre-operative screening tool for patients undergoing surgery, in order to assign a level of risk for chronic post-surgical opioid use.

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Study Type : Observational
Actual Enrollment : 1013 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence and Predictors of Prolonged Post-surgical Opioid Use: a Prospective Observational Cohort Study
Study Start Date : October 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Exposure of interest: continued use of opioid analgesics >90 days post-surgery




Primary Outcome Measures :
  1. Continued opioid use [ Time Frame: 90 days post-surgery ]
    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.


Secondary Outcome Measures :
  1. Pain scores (score/10) [ Time Frame: 90 days post-surgery ]
    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.

  2. Presence of pre-operative potential predictors of delayed opioid cessation [ Time Frame: 90 days post-surgery ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02571400


Locations
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Australia, New South Wales
St Vincent's Private Hospital, Sydney
Sydney, New South Wales, Australia, 2010
Sponsors and Collaborators
University of Notre Dame Australia
St Vincent's Hospital, Sydney
Investigators
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Principal Investigator: Jennifer A Stevens, MBChB St Vincent's Hospital, Sydney
Publications:

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Responsible Party: Natasha Stark, Medical student, University of Notre Dame Australia
ClinicalTrials.gov Identifier: NCT02571400    
Other Study ID Numbers: UNDAustralia
First Posted: October 8, 2015    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Natasha Stark, University of Notre Dame Australia:
Risk
Opioid analgesics
Opioid-related disorders
Surgery
Post-operative care
Post-operative period
Post-operative complications
Opioid Use disorders
Pain, post-operative
Opiate Addiction
Additional relevant MeSH terms:
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Disease
Pain, Postoperative
Postoperative Complications
Opioid-Related Disorders
Behavior, Addictive
Pathologic Processes
Compulsive Behavior
Impulsive Behavior
Pain
Neurologic Manifestations
Signs and Symptoms
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Analgesics
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents