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Pain AND Opioids After Surgery

NCT ID: NCT05877157

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-25

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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PANDOS is an international, prospective, observational cohort study. In a one week period (the designated "study week"), data will be collected in all eligible hospitalised adult patients who undergo surgery in as many hospitals as possible in the UK and Europe. Participants will be followed up for 12 months

Conditions

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Opioid Use Pain, Chronic Pain, Postoperative Quality of Life

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Society of Anaesthesiology and Intensive Care

OTHER

Sponsor Role collaborator

University of Aberdeen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrice Forget

Role: PRINCIPAL_INVESTIGATOR

University of Aberdeen

Locations

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Department of Anaesthesiology Sestre Milosrdnice, University Hospital Center

Zagreb, Vinogradska 29, Croatia

Site Status NOT_YET_RECRUITING

NHS Grampian

Aberdeen, , United Kingdom

Site Status RECRUITING

University College London Hospitals NHS Foundation Trust

London, , United Kingdom

Site Status ACTIVE_NOT_RECRUITING

Kings Mill Hospital, Sherwood Forest Hospitals NHS Foundation Trust

Nottingham, , United Kingdom

Site Status ACTIVE_NOT_RECRUITING

Countries

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Croatia United Kingdom

Central Contacts

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Patrice Forget

Role: CONTACT

Phone: 01224437285

Email: [email protected]

Holly R Keir, PhD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Tomislav Radocaj

Role: primary

Other Identifiers

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2-082-21

Identifier Type: -

Identifier Source: org_study_id