Opioid UsePANDOSNCT05877157
Pain AND Opioids After Surgery
An observational study of Opioid Use and Pain, Chronic, run by University of Aberdeen at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use, Pain, Chronic, Pain, Postoperative
- How many people
- 10,000 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 25 Sep 2023to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All eligible patients undergoing surgery at the hospital during the designated study week
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Holly R Keir, PhD contact
4 sites in 2 countries
United Kingdom3 sites, 1 recruiting
- Recruiting
NHS Grampian
Aberdeen
- Active, not recruiting
University College London Hospitals NHS Foundation Trust
London
- Active, not recruiting
Kings Mill Hospital, Sherwood Forest Hospitals NHS Foundation Trust
Nottingham
Croatia1 site, 1 recruiting
- Not yet recruiting
Department of Anaesthesiology Sestre Milosrdnice, University Hospital Center
Zagreb, Vinogradska 29, 10000
Tomislav Radocaj, +38591 1262 586, tomislav.radocaj@kbcsm.hr
About this study
Official title: Pain and Opioids After Surgery (PANDOS) Study
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.
Read the detailed description
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
- Opioid Use, Pain, Chronic, Pain, Postoperative, Quality of Life
- Medical subject headings
- Chronic Pain, Pain, Postoperative
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported Opioid use post surgery
Patient reported use of opioids post surgery
Measured: 3 months
Secondary outcomes (6)
Opioid use
Patient reported use of opioids pre-op and opioids used during surgery and prescribed post surgery
Measured: From recruitment to 1 year post surgery
Patient reported incidence of pain pre-op and post surgery using BPI-SF
Patient reported incidence of pain pre-op and post surgery using BPI-SF
Measured: From recruitment to 1 year post surgery
Patient reported incidence of pain pre-op and post surgery using DN2
Patient reported incidence of pain pre-op and post surgery using DN2
Measured: From recruitment to 1 year post surgery
Surgical complications
Recording of surgical complications during surgery
Measured: During surgery
Participant reported quality of life EQ5D-5L
EQ5D-5L
Measured: From recruitment to 1 year post surgery
Participant reported quality of life BPI-SF
BPI-SF
Measured: From recruitment to 1 year post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start25 Sep 2023
- Primary completion30 May 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- European Society of Anaesthesiology and Intensive Care
- Responsible party
- Sponsor
- Investigators
- Patrice Forget, Principal investigator, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05877157
- Sponsor's protocol ID
- 2-082-21
- Acronym
- PANDOS
- Status last verified
- Dec 2024
- First submitted
- 6 Apr 2023
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain and Opioids After Surgery (PANDOS) Study
- ClinicalTrials.gov ID
- NCT05877157
- Acronym / sponsor ID
- PANDOS / 2-082-21
- Conditions
- Opioid Use, Pain, Chronic, Pain, Postoperative, Quality of Life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- European Society of Anaesthesiology and Intensive Care
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All eligible patients undergoing surgery at the hospital during the designated study week
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient reported Opioid use post surgery
Time frame: 3 months
Patient reported use of opioids post surgery
6 secondary outcomes
Opioid use
Time frame: From recruitment to 1 year post surgery
Patient reported incidence of pain pre-op and post surgery using BPI-SF
Time frame: From recruitment to 1 year post surgery
Patient reported incidence of pain pre-op and post surgery using DN2
Time frame: From recruitment to 1 year post surgery
Surgical complications
Time frame: During surgery
Participant reported quality of life EQ5D-5L
Time frame: From recruitment to 1 year post surgery
Participant reported quality of life BPI-SF
Time frame: From recruitment to 1 year post surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Holly R Keir, PhD contact
Patrice Forget principal investigator
University of Aberdeen
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Use and Pain, Chronic, run by University of Aberdeen at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom, Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrice Forget (01224437285, patrice.forget@abdn.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient reported Opioid use post surgery (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.