Pain AND Opioids After Surgery

Quality of Life Clinical Trial

— PANDOS  

Official title:

Pain and Opioids After Surgery (PANDOS) Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05877157
• Other study ID #: 2-082-21
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

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

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