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ArrhythmiaNCT04868058

Serratus Anterior or Erector Spinae Block for Hybrid Arrhythmia Ablation Surgery

A study testing Ropivacaine injection in people with Arrhythmia, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to evaluate differences between single-shot EQUAL ropivacaine doses of the serratus anterior plane block (SAPB) or erector spinae plane block (ESPB) injection, when used as adjuvant to treat postoperative pain, after one-stage unilateral hybrid arrhythmia (atrial fibrillation, ventricular… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Arrhythmia
What is being tested?
Ropivacaine injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteBelgium
Study dates
2 Oct 2020to 1 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-80 years.
  • Provision of signed informed consent prior to any study-specific procedure
  • Selected for Hybrid Rhythm ablation surgery (ISNT, VT, AF)
  • American Society of Anesthesiologist physical Status I to III
  • Dutch, French or English speaking
  • Ability to follow the study protocol
  • BMI > 35 kg/m2 . BMI or Body mass index will be obtained from body weight in kg divided by the square of the length in meter and is expressed in kg/m2
  • -

Who cannot join

  • a. History of chronic pain or drug treatment abuse
  • b. Depression, psychiatric morbidity or mal-adaptive coping behaviour
  • c. Neuropathy
  • d. Severe anxiety or other mental ailment, taking drugs affecting their capacity to assess pain (gabapentin, pregabalin, opiod use)
  • e. Chronic or acute skin infection of the back or the lateral thorax
  • f. Hypersensitivity to ropivacaine
  • g. Severe hepatic, renal , pulmonary or cardiac (EF < 30%) disease or refuse to participate to the study..

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Universitair Ziekenhuis

    Brussels, Brussels Capital, 1090

Other trials in Belgium

About this study

Official title: Serratus Anterior Plane Block or Erector Spinae Plane Block Used as an Adjuvant for Hybrid Arrhythmia Ablation Surgery

The purpose of this study is to evaluate differences between single-shot EQUAL ropivacaine doses of the serratus anterior plane block (SAPB) or erector spinae plane block (ESPB) injection, when used as adjuvant to treat postoperative pain, after one-stage unilateral hybrid arrhythmia (atrial fibrillation, ventricular tachycardia, inappropriate sinus node tachycardia) ablation surgery. The primary outcomes are to evaluate block placement efficacy in the hybrid surgery setting (total time to block placement in seconds, time to visualization of location of injection in seconds, adequacy of ropivacaine spread) by picturing and worst numerical scale pain at rest or moving, using a visual analog pain scale from 0= no pain to 10= maximal pain, in the first 12 hours after admission to the post-anaesthesia care unit. Secondary outcomes aim to evaluate to investigate pain location, additional analgesic consumption and requests, ease of breathing, breathing quality, sleeping quality and quantity, duration of hospitalisation, and general level of satisfaction.

Read the detailed description

This clinical investigation is an interventional uni-center, prospective, open, randomized, double arm, blinded to the pain physician and the patient, clinical evaluation.

To ensure the same number of patients in each group, a stratified block randomization will be performed. A randomization list is generated for each type of arrhythmia. Patients will be block randomized into two groups: the serratus anterior plane block (SAPB) arm or the erector spinae plane block (ESPB) arm. As such the nerve block performing physician will be informed on the nerve block choice just before surgery.

132 consecutive patients. (22 in each group) Single Center study: Universitair Ziekenhuis Brussel - department of Anesthesiology 3 years Subject will be followed till 3 days post-procedure

Primary outcome measurement details:

The total time to block placement is obtained by starting a timer after local antiseptic application, just before puncturing the skin, to full injection of the local anaesthetic ropivacaine where the timer will be stopped.

In practice: a physician places the nerve block, a nurse anaesthetist manages the patient and a second nurse assistant records the timing and takes a picture just before drug injection and after block injection The time to visualization of the optimal location before nerve block injection is defined as the time needed to find the best place before local anaesthetic injection.

A picture of the location will be taken just before and after injection (by the second nurse assistant with an I-phone or similar device and kept with the patient's file Pain assessment will start 1 h after ICU admission by a different team (ICU nurse- intensive care physician or pain nurse). The first 24h assessments are blinded to the block performing physician.

Visual- analog- pain scores (0 no pain-10= maximal pain) will be analysed at rest or moving every 4 h or more depending on the patient's needs/requests for the first 24 h. After this period pain will be analysed twice daily (morning and afternoon) up to 72 h after start of surgery or less when dismissed earlier.

Secondary outcome measurements will be recorded after the initial 24h twice/da (morning and afternoon) by a pain nurse. Written data will be transmitted for storage to REDCAP.

Conditions
Arrhythmia
Being tested
Ropivacaine injection
Keywords
Arrhythmia, Ablation, Pain
Medical subject headings
Arrhythmias, Cardiac, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ropivacaine injectionDrug

    Also called Naropin

    Ropivacaine : 0.4 ml/kg (ideal body weight!) of 5mg/ml (20 to 30 ml bolus dose (100-150 mg), maximum dose 200 mg ropivacaine

Study groups in NCT04868058
Study groupRoleWhat they receive
1 AF SAPBExperimentalAtrial fibrillation. Serratus anterior plane block
Receives: Drug: Ropivacaine injection
2 AF ESPBExperimentalAtrial fibrillation. Erector spinae plane block
Receives: Drug: Ropivacaine injection
3 VT SAPBExperimentalVentricular Tachycardia.Serratus anterior plane block
Receives: Drug: Ropivacaine injection
4 VT ESPBExperimentalVentricular Tachycardia. Erector spinae plane block
Receives: Drug: Ropivacaine injection
5 ISNT SAPBExperimentalInappropriate Sinus node tachycardia. Serratus anterior plane block
Receives: Drug: Ropivacaine injection
6 ISNT ESPBExperimentalInappropriate Sinus node tachycardia. Erector spinae plane block
Receives: Drug: Ropivacaine injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. evaluate block placement efficacy in the hybrid surgery setting specifically time to placement in seconds

    Time to placement in seconds

    Measured: Time to placement: 1200 seconds

  2. evaluate block placement efficacy in the hybrid surgery setting visualization time of location of injection by picturing

    visualisation time of location of injection

    Measured: Visualisation is done by picturing to confirm adequate block (up 120 seconds)

  3. evaluate block placement efficacy in the hybrid surgery setting adequacy of ropivacaine spread by picturing

    Block placement efficacy by seeing the ropivacaine spread

    Measured: picturing Confirms time of block placement (up to 300 seconds)

  4. Worst numerical scale pain in the first 12 h after admission to the post-anaesthesia care unit.

    Maximal pain assesed by visual analog scale ,where 0= no pain 10= maximal pain

    Measured: 12 hours

Secondary outcomes (7)

  1. Pain location

    Place of pain: sternal; back, thorax, shoulder, throat, neck

    Measured: 72 hours

  2. Additional analgesic consumption and requests

    Pain drugs used: paracetamol in grams, piritramide in milligrams, diclofenac in milligrams, aspirin in milligrams, colchicine in grams

    Measured: 72 hours

  3. Ease of breathing, breathing quality

    Breathing evaluation: superficial, tense, normal, deep

    Measured: 72 hours

  4. Sleeping quantity

    Number of hours slept after surgery

    Measured: 72 hours

  5. Duration hospital Stay

    Length of hospital stay

    Measured: From 2 to 15 days

  6. Body Mass Index

    BMI or Body mass index is obtained from body weight in kg divided by the square of the length in meter) and is expressed in kg/m2).Exclusion criteria if above > 35 kg/m2

    Measured: Will be assessed on screening day or exported up to 2 weeks before screening day.

  7. Ideal body weight

    Ideal body weight will be calculated from body weight in kg, length in cm and gender on https://by globalrph.com/medcalc. It is expressed in kg and used for drug dosing

    Measured: Will be assessed on screening day or exported up to 2 weeks before screening day.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2021
  2. Study start2 Oct 2020
  3. Primary completion11 May 2021
  4. Study completion1 Dec 2024

Why it stopped: not enough patients were recruited

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
This clinical investigation is an interventional uni-center, prospective, open, randomized, double arm, blinded to the pain physician and the patient, clinical evaluation
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04868058
Sponsor's protocol ID
SAPB-ESPB hybrid AAS study
Status last verified
Dec 2025
First submitted
2 Dec 2019
Last updated
18 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Ropivacaine injection in people with Arrhythmia, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: not enough patients were recruited). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

evaluate block placement efficacy in the hybrid surgery setting specifically time to placement in seconds (time frame: Time to placement: 1200 seconds). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04868058.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.

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