NCT05211492

Brief Summary

After one-stage hybrid arrhythmia ablation surgery there are possible side effects like acute and chronic pain. There is a lot of research surrounding these pains but not specifically after one-stage hybrid arrhythmia ablation surgery. The investigators want to research factors that may be associated with the absence of chronic pain after hybrid ablation include ketamine, peroperative opioids, loco-regional blocks, neuraxial blocks, wound infiltration, postoperative patient-controlled analgesia. The presence of corticosteroids or NSAIDS, will also be evaluated. Furthermore, non-adaptable factors such as genetics complicate the onset of chronic post-operative pain. Taking existing knowledge in this field into account, incidence risk as well as acute pain duration and intensity and their effects on chronic pain will become the primary focus of this study. The investigators will contact all patients who had a one-stage hybrid arrhythmia ablation surgery at UZ Brussels. Participants will be sent a questionnaire with a consent form in and a survey asking about their pain 3 months postop and their current pain management therapy.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

December 22, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
1 year until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

December 18, 2025

Status Verified

April 1, 2023

Enrollment Period

2.3 years

First QC Date

December 22, 2021

Last Update Submit

December 11, 2025

Conditions

ArrythmiaChronic PainAcute PainPost Operative Pain

Outcome Measures

Primary Outcomes (2)

  • Number of patients with acute pain after one stage hybrid ablation.

    How many patients have acute pain after surgery

    3 months postop

  • Number of patients with chronic pain after one stage hybrid ablation.

    How many patients have acute pain after surgery

    3 months postop

Secondary Outcomes (6)

  • Intensity of immediate pain following one stage hybrid ablation

    3 days

  • Duration of immediate pain following one stage hybrid ablation

    3 days

  • Intensity of acute and chronic pain after receiving an advance anesthesiologic pain block.

    3 months

  • Intensity of acute and chronic pain after administration of ketamine.

    3 months

  • Intensity of acute and chronic pain after treatment with opioids.

    3 months

  • +1 more secondary outcomes

Study Arms (3)

Chronic pain

OTHER
Other: Questionnaire

Acute pain

OTHER
Other: Questionnaire

Control group

OTHER
Other: Questionnaire

Interventions

QuestionnaireOTHER

Patients are asked to fill in an online questionnaire concerning their postoperative pain.

Acute painChronic painControl group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • he/she must understand and read the Dutch, French or English language
  • be able to digitally agree to participate in the study
  • had to have a one stage hybrid procedure at least three months ago
  • have an ASA score of I, II or III.

You may not qualify if:

  • Patients with previously known chronic pain syndromes, fibromyalgia, complex regional pain syndrome are excluded.
  • Subjects with previous known chronic conditions such as diabetes neuropathy, rheumatoid arthri-tis, … are also excluded.
  • Subject are excluded if they underwent a surgical treatment within the observed period.
  • Patients are excluded when under treatment with chemotherapy/radiotherapy
  • Pregnant patients are also excluded.
  • Patients with known psychological conditions such as depression are excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Brussel

Jette, Brussels Capital, 1090, Belgium

Location

MeSH Terms

Conditions

Arrhythmias, CardiacChronic PainAcute PainPain, Postoperative

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPostoperative Complications

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: There are 3 groups. 1 chronic pain, 2 acute pain, 3 no pain
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2021

First Posted

January 27, 2022

Study Start

February 1, 2023

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

December 18, 2025

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)