Acute and Chronic Pain After One-stage Hybrid Arrhythmia Ablation Surgery

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Pain; Acute Pain; Post Operative Pain; Arrythmia
• Intervention / Treatment: Other: Questionnaire

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels Capital
    • Jette, Brussels Capital, Belgium, 1090
      • UZ Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control group	Other: Questionnaire; Patients are asked to fill in an online questionnaire concerning their postoperative pain.
Other: Chronic pain	Other: Questionnaire; Patients are asked to fill in an online questionnaire concerning their postoperative pain.
Other: Acute pain	Other: Questionnaire; Patients are asked to fill in an online questionnaire concerning their postoperative pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 days
Duration of immediate pain following one stage hybrid ablation	How long does the immediate pain post operation last?	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.	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.	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.	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.	3 months

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): June 1, 2025
• Study Completion (Actual): June 1, 2025

Study Registration Dates

• First Submitted: December 22, 2021
• First Submitted That Met QC Criteria: January 26, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Estimated): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Heart Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Chronic Pain; Acute Pain; Arrhythmias, Cardiac; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: Pain 1StageHybride Ablation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No