Pain AND Opioids After Surgery | NCT05877157

Studies
Pain AND Opioids After Surgery

NCT05877157

Sponsor

University of Aberdeen

Status

Recruiting

Last Update Posted

Dec 24, 2024Actual

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Opioid Use
Pain, Chronic
Pain, Postoperative
Quality of Life

Interventions

Not provided

Countries

Croatia
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 25, 2023Actual

Primary Completion Date

May 30, 2026Estimated

Completion Date

Sep 30, 2026Estimated

First Submitted Date

Apr 6, 2023

First Submission Date that Met QC Criteria

May 23, 2023

First Posted Date

May 26, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2024

Last Update Posted Date

Dec 24, 2024Actual

Name	Class
European Society of Anaesthesiology and Intensive Care	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

PANDOS is an international, prospective, observational cohort study. In a one week period (the designated "study week"), data will be collected in all eligible hospitalised adult patients who undergo surgery in as many hospitals as possible in the UK and Europe. Participants will be followed up for 12 months

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10,000Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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 pre-op and post surgery using BPI-SF

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Patrice Forget	Contact	01224437285		patrice.forget@abdn.ac.uk
Holly R Keir, PhD	Contact			PANDOS@abdn.ac.uk

Overall Officials

Name	Affiliation	Role
Patrice Forget	University of Aberdeen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anaesthesiology Sestre Milosrdnice, University Hospital Center	Not yet recruiting	Zagreb	Vinogradska 29	10000	Croatia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D059350	Chronic Pain
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided