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NCT Number: NCT05877157

Pain AND Opioids After Surgery

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anaesthesiology Sestre Milosrdnice, University Hospital Center, Zagreb, Vinogradska 29, Croatia

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Patient reported Opioid use post surgery

    Time frame: 3 months

    Patient reported use of opioids post surgery

Secondary outcomes

  1. Opioid use

    Time frame: 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 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 BPI-SF

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

    Time frame: From recruitment to 1 year post surgery

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

  4. Surgical complications

    Time frame: During surgery

    Recording of surgical complications during surgery

  5. Participant reported quality of life EQ5D-5L

    Time frame: From recruitment to 1 year post surgery

    EQ5D-5L

  6. Participant reported quality of life BPI-SF

    Time frame: From recruitment to 1 year post surgery

    BPI-SF

Study contacts

Contact information is provided by the study sponsor or research team.

Holly R Keir, PhD

CONTACT

[email protected]

Patrice Forget

CONTACT

[email protected]

01224437285

Sponsors and collaborators

Lead sponsor

University of Aberdeen

Other

Collaborators

  • European Society of Anaesthesiology and Intensive Care

Registry information

Official study title

Pain and Opioids After Surgery (PANDOS) Study

Acronym: PANDOS

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 26, 2023
Registry last updated
Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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