Acute and Chronic Pain After One-stage Hybrid Arrhythmia Ablation Surgery
Primary Purpose
Arrythmia, Chronic Pain, Acute Pain
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Questionnaire
Sponsored by
About this trial
This is an interventional supportive care trial for Arrythmia
Eligibility Criteria
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.
Sites / Locations
- UZ BrusselRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Chronic pain
Acute pain
Control group
Arm Description
Outcomes
Primary Outcome Measures
Number of patients with acute pain after one stage hybrid ablation.
How many patients have acute pain after surgery
Number of patients with chronic pain after one stage hybrid ablation.
How many patients have acute pain after surgery
Secondary Outcome Measures
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.
Duration of immediate pain following one stage hybrid ablation
How long does the immediate pain post operation last?
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.
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.
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.
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.
Full Information
NCT ID
NCT05211492
First Posted
December 22, 2021
Last Updated
April 26, 2023
Sponsor
Universitair Ziekenhuis Brussel
1. Study Identification
Unique Protocol Identification Number
NCT05211492
Brief Title
Acute and Chronic Pain After One-stage Hybrid Arrhythmia Ablation Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitair Ziekenhuis Brussel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrythmia, Chronic Pain, Acute Pain, Post Operative Pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There are 3 groups. 1 chronic pain, 2 acute pain, 3 no pain
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chronic pain
Arm Type
Other
Arm Title
Acute pain
Arm Type
Other
Arm Title
Control group
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Questionnaire
Intervention Description
Patients are asked to fill in an online questionnaire concerning their postoperative pain.
Primary Outcome Measure Information:
Title
Number of patients with acute pain after one stage hybrid ablation.
Description
How many patients have acute pain after surgery
Time Frame
3 months postop
Title
Number of patients with chronic pain after one stage hybrid ablation.
Description
How many patients have acute pain after surgery
Time Frame
3 months postop
Secondary Outcome Measure Information:
Title
Intensity of immediate pain following one stage hybrid ablation
Description
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.
Time Frame
3 days
Title
Duration of immediate pain following one stage hybrid ablation
Description
How long does the immediate pain post operation last?
Time Frame
3 days
Title
Intensity of acute and chronic pain after receiving an advance anesthesiologic pain block.
Description
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.
Time Frame
3 months
Title
Intensity of acute and chronic pain after administration of ketamine.
Description
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.
Time Frame
3 months
Title
Intensity of acute and chronic pain after treatment with opioids.
Description
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.
Time Frame
3 months
Title
Intensity of acute and chronic pain after placing of a thorax drain post operatively.
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
UZ Brussel
City
Jette
State/Province
Brussel
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evelien Vandeurzen, Biomedical Sciences
Phone
024749237
Email
evelien.vandeurzen@uzbrussel.be
First Name & Middle Initial & Last Name & Degree
Christian Verborgh, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Acute and Chronic Pain After One-stage Hybrid Arrhythmia Ablation Surgery
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