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

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05211492
• Other study ID #: Pain 1StageHybride Ablation
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: July 2023

Study information

• Verified date: April 2023
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Arrhythmias, Cardiac
• Arrythmia
• Chronic Pain
• Pain, Postoperative
• Post Operative Pain

Intervention

Other:
• Questionnaire
Patients are asked to fill in an online questionnaire concerning their postoperative pain.

Locations

Country	Name	City	State
Belgium	UZ Brussel	Jette	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with acute pain after one stage hybrid ablation.	How many patients have acute pain after surgery	3 months postop
Primary	Number of patients with chronic pain after one stage hybrid ablation.	How many patients have acute pain after surgery	3 months postop
Secondary	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
Secondary	Duration of immediate pain following one stage hybrid ablation	How long does the immediate pain post operation last?	3 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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