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Pain AND Opioids After Surgery

Sponsor: University of Aberdeen

NCT ID: NCT05877157

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 36 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
10,000
Started
2023-09-25
Last checked
2024-12

Plain English Summary

What is this study?

  • • Testing a new treatment for opioid use
  • • Clinical study - 10,000 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with opioid use

Where?

  • • Aberdeen - NHS Grampian
  • • London - University College London Hospitals NHS Foundation Trust
  • • Nottingham - Kings Mill Hospital, Sherwood Forest Hospitals NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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

Opioid UsePain, ChronicPain, PostoperativeQuality of Life

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Able to understand and has capacity to give written agreement to take part

Who cannot take part

  • ✗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 agreement to take part
See the full criteria
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

Where Is This Study? (3 UK sites)

NHS Grampian

Aberdeen, United Kingdom

Recruiting
Hospital R&D contact (matched)

Fiona Brebner

gram.randd@nhs.scot01224 551121

University College London Hospitals NHS Foundation Trust

London, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Rajinder Sidhu - Associate Director, Research Governance and Operations

uclh.jro-communications@nhs.net020 3447 9825

Kings Mill Hospital, Sherwood Forest Hospitals NHS Foundation Trust

Nottingham, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Alison Steel

sfh-tr.researchandinnovation@nhs.net01623 622515 ext 3990

How to Get in Touch

Patrice Forget

Sponsor contact

CONTACT

01224437285 patrice.forget@abdn.ac.uk

Holly R Keir, PhD

Sponsor contact

CONTACT

PANDOS@abdn.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2024-12