Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

9. maj 2017 opdateret af: Natasha Stark, University of Notre Dame Australia
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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

1013

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • New South Wales
      • Sydney, New South Wales, Australien, 2010
        • St Vincent's Private Hospital, Sydney

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Patients scheduled to undergo surgery
Patients scheduled to undergo surgery at St Vincent's Private Hospital Sydney
Exposure of interest: continued use of opioid analgesics >90 days post-surgery

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Continued opioid use
Tidsramme: 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.
90 days post-surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain scores (score/10)
Tidsramme: 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.
90 days post-surgery
Presence of pre-operative potential predictors of delayed opioid cessation
Tidsramme: 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.

90 days post-surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Jennifer A Stevens, MBChB, St Vincent's Hospital, Sydney

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2015

Primær færdiggørelse (Faktiske)

1. oktober 2016

Studieafslutning (Faktiske)

1. oktober 2016

Datoer for studieregistrering

Først indsendt

5. oktober 2015

Først indsendt, der opfyldte QC-kriterier

7. oktober 2015

Først opslået (Skøn)

8. oktober 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. maj 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. maj 2017

Sidst verificeret

1. maj 2017

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner