Pain AND Opioids After Surgery

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Aberdeen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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

Trial population

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

Trial design

Design model

Ecologic or community

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Patient reported Opioid use post surgery

Patient reported use of opioids post surgery

Time frame
3 months

Secondary outcomes

1

Opioid use

Patient reported use of opioids pre-op and opioids used during surgery and prescribed post surgery

Time frame
From recruitment to 1 year post surgery
2

Patient reported incidence of pain pre-op and post surgery using BPI-SF

Patient reported incidence of pain pre-op and post surgery using BPI-SF

Time frame
From recruitment to 1 year post surgery
3

Patient reported incidence of pain pre-op and post surgery using DN2

Patient reported incidence of pain pre-op and post surgery using DN2

Time frame
From recruitment to 1 year post surgery
4

Surgical complications

Recording of surgical complications during surgery

Time frame
During surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Aberdeen

Lead sponsor

European Society of Anaesthesiology and Intensive Care

Collaborator