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

Sponsor
Universitair Ziekenhuis Brussel (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05211492
Collaborator
(none)
150
1
3
4.9
30.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaire
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
There are 3 groups. 1 chronic pain, 2 acute pain, 3 no painThere are 3 groups. 1 chronic pain, 2 acute pain, 3 no pain
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
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
Anticipated Study Start Date :
Feb 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

Other: Control group

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

Outcome Measures

Primary Outcome Measures

  1. Number of patients with acute pain after one stage hybrid ablation. [3 months postop]

    How many patients have acute pain after surgery

  2. Number of patients with chronic pain after one stage hybrid ablation. [3 months postop]

    How many patients have acute pain after surgery

Secondary Outcome Measures

  1. Intensity of immediate pain following one stage hybrid ablation [3 days]

    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.

  2. Duration of immediate pain following one stage hybrid ablation [3 days]

    How long does the immediate pain post operation last?

  3. Intensity of acute and chronic pain after receiving an advance anesthesiologic pain block. [3 months]

    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.

  4. Intensity of acute and chronic pain after administration of ketamine. [3 months]

    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.

  5. Intensity of acute and chronic pain after treatment with opioids. [3 months]

    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.

  6. Intensity of acute and chronic pain after placing of a thorax drain post operatively. [3 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 UZ Brussel Jette Brussel Belgium 1090

Sponsors and Collaborators

  • Universitair Ziekenhuis Brussel

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT05211492
Other Study ID Numbers:
  • Pain 1StageHybride Ablation
First Posted:
Jan 27, 2022
Last Update Posted:
Jan 27, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 27, 2022