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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05877157
Other study ID # 2-082-21
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 25, 2023
Est. completion date September 30, 2025

Study information

Verified date February 2024
Source University of Aberdeen
Contact Patrice Forget
Phone 01224437285
Email patrice.forget@abdn.ac.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10000
Est. completion date September 30, 2025
Est. primary completion date September 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
United Kingdom 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

Sponsors (2)

Lead Sponsor Collaborator
University of Aberdeen European Society of Anaesthesiology and Intensive Care

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient reported Opioid use post surgery Patient reported use of opioids post surgery 3 months
Secondary 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
Secondary 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
Secondary Patient reported incidence of pain Patient reported incidence of pain pre-op and post surgery using DN2 From recruitment to 1 year post surgery
Secondary Surgical complications Recording of surgical complications during surgery During surgery
Secondary Participant reported quality of life EQ5D-5L From recruitment to 1 year post surgery
Secondary Participant reported quality of life BPI-SF From recruitment to 1 year post surgery
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