NCT05244655

Brief Summary

In this retrospective cohort study, we assess the relationship between the intensity of early postoperative pain and the risk of infectious- and non-infectious complications within 30 days after major abdominal surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 8, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 17, 2022

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2023

Completed
Last Updated

April 4, 2024

Status Verified

November 1, 2021

Enrollment Period

1 month

First QC Date

February 8, 2022

Last Update Submit

April 2, 2024

Conditions

Infectious ComplicationsPostoperative PainAcute PainPostoperative ComplicationsSurgery--Complications

Keywords

Early postoperative painInfectious complications

Outcome Measures

Primary Outcomes (1)

  • Acute postoperative pain

    Early pain following abdominal surgery POD1

    1 day

Secondary Outcomes (2)

  • Infectious complications postoperative

    30 days

  • Overall complications postoperative

    30 days

Study Arms (2)

Patients without painscores available during hospital stay

Patients with painscores available during hospital stay

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients who underwent major abdominal surgery, mostly electively scheduled, between January 2014 and December 2020 were considered eligible for participation in our study.

You may qualify if:

  • Major abdominal surgery under general anesthesia

You may not qualify if:

  • younger than 18 years of age
  • procedures outside the operation room
  • procedures solely under regional anesthesia, i.e. no general anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RadboudUMC

Nijmegen, Gelderland, Netherlands

Location

Related Publications (1)

  • Bijkerk V, Jacobs LMC, Visser J, van Helden EV, Keijzer C, Helder LS, Albers KI, Warle MC. The immunomodulatory effect of sugammadex in vitro and after total hip arthroplasty : A randomised controlled pilot and retrospective cohort study. Eur J Anaesthesiol. 2025 Aug 1;42(8):676-686. doi: 10.1097/EJA.0000000000002132. Epub 2025 Feb 14.

    PMID: 39957489DERIVED

MeSH Terms

Conditions

Pain, PostoperativeAcute PainPostoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2022

First Posted

February 17, 2022

Study Start

December 1, 2021

Primary Completion

January 3, 2022

Study Completion

December 8, 2023

Last Updated

April 4, 2024

Record last verified: 2021-11

Locations

NL(1)