Pain AND Opioids After Surgery

NCT05877157 | Recruiting

• 1 other identifier: 2-082-21
• Study Type: observational
• Target: 10,000
• Locations: 2 countries
• Sites: 4

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.

Conditions

Opioid Use; Pain, Chronic; Pain, Postoperative; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Patient reported Opioid use post surgery

  Patient reported use of opioids post surgery

  3 months

Secondary Outcomes (6)

• Opioid use

  From recruitment to 1 year 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 DN2

  From recruitment to 1 year post surgery

• Surgical complications

  During surgery

• Participant reported quality of life EQ5D-5L

  From recruitment to 1 year post surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aberdeen: lead
• European Society of Anaesthesiology and Intensive Care: collaborator

Study Sites (4)

Department of Anaesthesiology Sestre Milosrdnice, University Hospital Center

Zagreb, Vinogradska 29, 10000, Croatia

NOT YET RECRUITING

NHS Grampian

Aberdeen, United Kingdom

RECRUITING

University College London Hospitals NHS Foundation Trust

London, United Kingdom

ACTIVE NOT RECRUITING

Kings Mill Hospital, Sherwood Forest Hospitals NHS Foundation Trust

Nottingham, United Kingdom

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Chronic Pain; Pain, Postoperative

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Patrice Forget

  University of Aberdeen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrice Forget

CONTACT

01224437285; patrice.forget@abdn.ac.uk

Holly R Keir, PhD

CONTACT

PANDOS@abdn.ac.uk

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: May 26, 2023
• Study Start: September 25, 2023
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1); GB (3)