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Pain AND Opioids After Surgery (PANDOS)

U

University of Aberdeen

Status

Enrolling

Conditions

Quality of Life
Pain, Postoperative
Pain, Chronic
Opioid Use

Study type

Observational

Funder types

Other

Identifiers

NCT05877157
2-082-21

Details and patient eligibility

About

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.

Full 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

Enrollment

10,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

4

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Central trial contact

Patrice Forget; Holly R Keir, PhD

Data sourced from clinicaltrials.gov

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