PANDOS: Pain AND Opioids After Surgery

Sponsor
University of Aberdeen (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05877157
Collaborator
European Society of Anaesthesiology and Intensive Care (Other)
10,000
14

Study Details

Study Description

Brief Summary

The aim of this study is to document the perioperative opioid use and its safety in the UK and countries in Europe and to describe its association with surgical complications, persistent pain and quality of life. In an international, prospective, observational cohort study, data about the perioperative pain management will be collected in all eligible hospitalised adult patients who undergo surgery in a designated "study week" in as many hospitals as possible in Europe. Baseline data will be collected, and participants followed up at one week, and at three and twelve months post-operatively. The primary outcome will be opioid use at three months after surgery. Secondary outcomes will include opioid use during the preoperative month (preoperative use), during surgery and up to one week after surgery (or discharge, whichever is earlier), and up to the end of the postoperative year. Additional secondary outcomes are the incidence of preoperative pain, persistent pain with/without the presence of neuropathic components, quality of life and surgical complications. The potential association between opioid use and pain outcomes will be investigated. This study could help to develop strategies to improve quality of care, through pain management, for patients undergoing surgery.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    10000 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Prospective
    Official Title:
    Pain and Opioids After Surgery (PANDOS) Study
    Anticipated Study Start Date :
    Jun 1, 2023
    Anticipated Primary Completion Date :
    Apr 30, 2024
    Anticipated Study Completion Date :
    Jul 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Patient reported Opioid use post surgery [3 months]

      Patient reported use of opioids post surgery

    Secondary Outcome Measures

    1. Opioid use [From recruitment to 1 year post surgery]

      Patient reported use of opioids pre-op and opioids used during surgery and prescribed post surgery

    2. Patient reported incidence of pain [From recruitment to 1 year post surgery]

      Patient reported incidence of pain pre-op and post surgery using BPI-SF

    3. Patient reported incidence of pain [From recruitment to 1 year post surgery]

      Patient reported incidence of pain pre-op and post surgery using DN2

    4. Surgical complications [During surgery]

      Recording of surgical complications during surgery

    5. Participant reported quality of life [From recruitment to 1 year post surgery]

      EQ5D-5L

    6. Participant reported quality of life [From recruitment to 1 year post surgery]

      BPI-SF

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • hospitalised adult patients (18 years and older) undergoing any inpatient surgery (elective or emergency) during the designated study week where an anaesthetist is involved (general anaesthetic, sedation, local anaesthetic).

    Able to understand and has capacity to give written informed consent

    Exclusion Criteria:
    • American Society of Anaesthesiologists (ASA) grade V or VI

    • Refusal to participate.

    • Lack of comprehension of validated questionnaires or inability to complete the follow-up for any reason.

    • Lack of capacity to give written informed consent

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Aberdeen
    • European Society of Anaesthesiology and Intensive Care

    Investigators

    • Principal Investigator: Patrice Forget, University of Aberdeen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Aberdeen
    ClinicalTrials.gov Identifier:
    NCT05877157
    Other Study ID Numbers:
    • 2-082-21
    First Posted:
    May 26, 2023
    Last Update Posted:
    May 26, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 26, 2023