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Recruiting NCT05877157

Pain AND Opioids After Surgery

— Observational Opioid Use Pain, Chronic Pain, Postoperative Quality of Life

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Opioid Use, Pain, Chronic, Pain, Postoperative, Quality of Life. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Croatia, United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Pain and Opioids After Surgery (PANDOS) Study

Overview

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

Primary outcome measures

  • Patient reported Opioid use post surgery [Time frame: 3 months]
Secondary outcome measures (6)
  • 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]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Ecologic or community

Study locations

United Kingdom · 3 centers
  • NHS Grampian — Aberdeen
  • University College London Hospitals NHS Foundation Trust — London
  • Kings Mill Hospital, Sherwood Forest Hospitals NHS Foundation Trust — Nottingham
Croatia · 1 center
  • Department of Anaesthesiology Sestre Milosrdnice, University Hospital Center — Zagreb

Identifiers

NCT: NCT05877157 · 2-082-21

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗