Clinical trial NCT05877157: Pain AND Opioids After Surgery
Official title: Pain and Opioids After Surgery (PANDOS) Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Opioid Use
Pain, Chronic
Pain, Postoperative
Quality of Life
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
Collaborators: name: European Society of Anaesthesiology and Intensive Care
First posted: 2023-05-26
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible patients undergoing surgery at the hospital during the designated study week

Brief 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. 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

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

Primary outcomes:
measure: Patient reported Opioid use post surgery
timeFrame: 3 months
Secondary outcomes:
measure: Opioid use
timeFrame: From recruitment to 1 year post surgery
measure: Patient reported incidence of pain pre-op and post surgery using BPI-SF
timeFrame: From recruitment to 1 year post surgery
measure: Patient reported incidence of pain pre-op and post surgery using DN2
timeFrame: From recruitment to 1 year post surgery
measure: Surgical complications
timeFrame: During surgery
measure: Participant reported quality of life EQ5D-5L
timeFrame: From recruitment to 1 year post surgery
measure: Participant reported quality of life BPI-SF
timeFrame: From recruitment to 1 year post surgery
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Department of Anaesthesiology Sestre Milosrdnice, University Hospital Center
state: Vinogradska 29
city: Aberdeen
country: United Kingdom
facility: NHS Grampian
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: Kings Mill Hospital, Sherwood Forest Hospitals NHS Foundation Trust
Study officials:
affiliation: University of Aberdeen
name: Patrice Forget
role: PRINCIPAL_INVESTIGATOR
References: