Clinical trial NCT05211492: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Arrythmia
Chronic Pain
Acute Pain
Post Operative Pain
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are 3 groups. 1 chronic pain, 2 acute pain, 3 no pain
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Number of patients with acute pain after one stage hybrid ablation.
timeFrame: 3 months postop
measure: Number of patients with chronic pain after one stage hybrid ablation.
timeFrame: 3 months postop
Secondary outcomes:
measure: Intensity of immediate pain following one stage hybrid ablation
timeFrame: 3 days
measure: Duration of immediate pain following one stage hybrid ablation
timeFrame: 3 days
measure: Intensity of acute and chronic pain after receiving an advance anesthesiologic pain block.
timeFrame: 3 months
measure: Intensity of acute and chronic pain after administration of ketamine.
timeFrame: 3 months
measure: Intensity of acute and chronic pain after treatment with opioids.
timeFrame: 3 months
measure: Intensity of acute and chronic pain after placing of a thorax drain post operatively.
timeFrame: 3 months
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
state: Brussel
Study officials:
References: