Pain AND Opioids After Surgery
- Conditions
- Pain, PostoperativeOpioid UseQuality of LifePain, Chronic
- Registration Number
- NCT05877157
- Lead Sponsor
- University of Aberdeen
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10000
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient reported Opioid use post surgery 3 months Patient reported use of opioids post surgery
- Secondary Outcome Measures
Name Time Method Opioid use From recruitment to 1 year post surgery Patient reported use of opioids pre-op and opioids used during surgery and prescribed post surgery
Patient reported incidence of pain pre-op and post surgery using BPI-SF 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 DN2 From recruitment to 1 year post surgery Patient reported incidence of pain pre-op and post surgery using DN2
Surgical complications During surgery Recording of surgical complications during surgery
Participant reported quality of life EQ5D-5L From recruitment to 1 year post surgery EQ5D-5L
Participant reported quality of life BPI-SF From recruitment to 1 year post surgery BPI-SF
Trial Locations
- Locations (4)
Department of Anaesthesiology Sestre Milosrdnice, University Hospital Center
ðŸ‡ðŸ‡·Zagreb, Vinogradska 29, Croatia
NHS Grampian
🇬🇧Aberdeen, United Kingdom
University College London Hospitals NHS Foundation Trust
🇬🇧London, United Kingdom
Kings Mill Hospital, Sherwood Forest Hospitals NHS Foundation Trust
🇬🇧Nottingham, United Kingdom