Pain AND Opioids After Surgery (PANDOS)

Pain and Opioids After Surgery (PANDOS) Study

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Pain, Postoperative; Opioid Use; Pain, Chronic

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Patrice Forget; Phone Number: 01224437285; Email: patrice.forget@abdn.ac.uk
• Study Contact Backup: Name: Tracey Davidson, Msc; Phone Number: 01224 438180; Email: t.davidson@abdn.ac.uk

Study Locations

• United Kingdom
  • Aberdeen, United Kingdom
    • Recruiting
    • NHS Grampian
  • London, United Kingdom
    • Active, not recruiting
    • University College London Hospitals NHS Foundation Trust
  • Nottingham, United Kingdom
    • Active, not recruiting
    • Kings Mill Hospital, Sherwood Forest Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All eligible patients undergoing surgery at the hospital during the designated study week

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported Opioid use post surgery	Patient reported use of opioids post surgery	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid use	Patient reported use of opioids pre-op and opioids used during surgery and prescribed post surgery	From recruitment to 1 year post surgery
Patient reported incidence of pain	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	Patient reported incidence of pain pre-op and post surgery using DN2	From recruitment to 1 year post surgery
Surgical complications	Recording of surgical complications during surgery	During surgery
Participant reported quality of life	EQ5D-5L	From recruitment to 1 year post surgery
Participant reported quality of life	BPI-SF	From recruitment to 1 year post surgery

Collaborators and Investigators

• Sponsor: University of Aberdeen
• Collaborators: European Society of Anaesthesiology and Intensive Care
• Investigators: Principal Investigator: Patrice Forget, University of Aberdeen

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2023
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: April 6, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Actual): May 26, 2023

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Chronic Pain
• Other Study ID Numbers: 2-082-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No