ArrythmiaNCT05211492
Acute and Chronic Pain After One-stage Hybrid Arrhythmia Ablation Surgery
A study testing Questionnaire in people with Arrythmia and Chronic Pain, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrythmia, Chronic Pain, Acute Pain
- What is being tested?
- Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2023to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute and Chronic Pain After One-stage Hybrid Arrhythmia Ablation Surgery: A Study on the Presence of Chronic Pain After Hybrid Ablation and Factors That May be Associated
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.
- Conditions
- Arrythmia, Chronic Pain, Acute Pain, Post Operative Pain
- Being tested
- Questionnaire
- Medical subject headings
- Arrhythmias, Cardiac, Chronic Pain, Acute Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Patients are asked to fill in an online questionnaire concerning their postoperative pain.
| Study group | Role | What they receive |
|---|---|---|
| Chronic pain | Other | Not described Receives: Other: Questionnaire |
| Acute pain | Other | Not described Receives: Other: Questionnaire |
| Control group | Other | Not described Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with acute pain after one stage hybrid ablation.
How many patients have acute pain after surgery
Measured: 3 months postop
Number of patients with chronic pain after one stage hybrid ablation.
How many patients have acute pain after surgery
Measured: 3 months postop
Secondary outcomes (6)
Intensity of immediate pain following one stage hybrid ablation
How painful on a numeric pain scale rating of 0 to 10 is the immediate pain post operation? 10 being the worst pain ever felt and 0 being totally painfree.
Measured: 3 days
Duration of immediate pain following one stage hybrid ablation
How long does the immediate pain post operation last?
Measured: 3 days
Intensity of acute and chronic pain after receiving an advance anesthesiologic pain block.
How painful on a numeric pain scale rating of 0 to 10 is the acute or chronic pain post operation? 10 being the worst pain ever felt and 0 being totally pain free.
Measured: 3 months
Intensity of acute and chronic pain after administration of ketamine.
How painful on a numeric pain scale rating of 0 to 10 is the acute or chronic pain post operation? 10 being the worst pain ever felt and 0 being totally pain free.
Measured: 3 months
Intensity of acute and chronic pain after treatment with opioids.
How painful on a numeric pain scale rating of 0 to 10 is the acute or chronic pain post operation? 10 being the worst pain ever felt and 0 being totally pain free.
Measured: 3 months
Intensity of acute and chronic pain after placing of a thorax drain post operatively.
How painful on a numeric pain scale rating of 0 to 10 is the acute or chronic pain post operation? 10 being the worst pain ever felt and 0 being totally pain free.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start1 Feb 2023
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Why it stopped: not enough patients were recruited
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrythmiaStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- There are 3 groups. 1 chronic pain, 2 acute pain, 3 no pain
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211492
- Sponsor's protocol ID
- Pain 1StageHybride Ablation
- Status last verified
- Apr 2023
- First submitted
- 22 Dec 2021
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Chronic Pain After One-stage Hybrid Arrhythmia Ablation Surgery: A Study on the Presence of Chronic Pain After Hybrid Ablation and Factors That May be Associated
- ClinicalTrials.gov ID
- NCT05211492
- Acronym / sponsor ID
- Pain 1StageHybride Ablation
- Conditions
- Arrythmia, Chronic Pain, Acute Pain, Post Operative Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not enough patients were recruited
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- There are 3 groups. 1 chronic pain, 2 acute pain, 3 no pain
| Arm | Type | Receives |
|---|---|---|
| Chronic pain | Other | Other: Questionnaire |
| Acute pain | Other | Other: Questionnaire |
| Control group | Other | Other: Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairePatients are asked to fill in an online questionnaire concerning their postoperative pain. | Other | Acute pain, Chronic pain, Control group |
Primary outcome
Number of patients with acute pain after one stage hybrid ablation.
Time frame: 3 months postop
How many patients have acute pain after surgery
Number of patients with chronic pain after one stage hybrid ablation.
Time frame: 3 months postop
How many patients have acute pain after surgery
6 secondary outcomes
Intensity of immediate pain following one stage hybrid ablation
Time frame: 3 days
Duration of immediate pain following one stage hybrid ablation
Time frame: 3 days
Intensity of acute and chronic pain after receiving an advance anesthesiologic pain block.
Time frame: 3 months
Intensity of acute and chronic pain after administration of ketamine.
Time frame: 3 months
Intensity of acute and chronic pain after treatment with opioids.
Time frame: 3 months
Intensity of acute and chronic pain after placing of a thorax drain post operatively.
Time frame: 3 months
Results and safety
The study was stopped early (reason given: not enough patients were recruited). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire in people with Arrythmia and Chronic Pain, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: not enough patients were recruited). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with acute pain after one stage hybrid ablation. (time frame: 3 months postop). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.