Serratus Anterior or Erector Spinae Block for Hybrid Arrhythmia Ablation Surgery

NCT04868058 | Terminated

• 1 other identifier: SAPB-ESPB hybrid AAS study
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Arrhythmia

Keywords

Arrhythmia; Ablation; Pain

Outcome Measures

Primary Outcomes (4)

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

  Time to placement in seconds

  Time to placement: 1200 seconds

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

  visualisation time of location of injection

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

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

  Block placement efficacy by seeing the ropivacaine spread

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

• 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

  12 hours

Secondary Outcomes (7)

• Pain location

  72 hours

• Additional analgesic consumption and requests

  72 hours

• Ease of breathing, breathing quality

  72 hours

• Sleeping quantity

  72 hours

• Duration hospital Stay

  From 2 to 15 days

Study Arms (6)

1 AF SAPB

EXPERIMENTAL

Atrial fibrillation. Serratus anterior plane block

Drug: Ropivacaine injection

2 AF ESPB

EXPERIMENTAL

Atrial fibrillation. Erector spinae plane block

Drug: Ropivacaine injection

3 VT SAPB

EXPERIMENTAL

Ventricular Tachycardia.Serratus anterior plane block

Drug: Ropivacaine injection

4 VT ESPB

EXPERIMENTAL

Ventricular Tachycardia. Erector spinae plane block

Drug: Ropivacaine injection

5 ISNT SAPB

EXPERIMENTAL

Inappropriate Sinus node tachycardia. Serratus anterior plane block

Drug: Ropivacaine injection

6 ISNT ESPB

EXPERIMENTAL

Inappropriate Sinus node tachycardia. Erector spinae plane block

Drug: Ropivacaine injection

Interventions

Ropivacaine injection DRUG

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

Also known as: Naropin

1 AF SAPB; 2 AF ESPB; 3 VT SAPB; 4 VT ESPB; 5 ISNT SAPB; 6 ISNT ESPB

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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..

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair Ziekenhuis

Brussels, Brussels Capital, 1090, Belgium

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac; Pain

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: April 30, 2021
• Study Start: October 2, 2020
• Primary Completion: May 11, 2021
• Study Completion: December 1, 2024
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

BE (1)