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Serratus Anterior or Erector Spinae Block for Hybrid Arrhythmia Ablation Surgery

Primary Purpose

Arrhythmia

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Ropivacaine injection
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arrhythmia focused on measuring Arrhythmia, Ablation, Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18-80 years.
  2. Provision of signed informed consent prior to any study-specific procedure
  3. Selected for Hybrid Rhythm ablation surgery (ISNT, VT, AF)
  4. American Society of Anesthesiologist physical Status I to III
  5. Dutch, French or English speaking
  6. Ability to follow the study protocol
  7. 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

    -

    Exclusion Criteria:

    • 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..

Sites / Locations

  • Universitair ZiekenhuisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

1 AF SAPB

2 AF ESPB

3 VT SAPB

4 VT ESPB

5 ISNT SAPB

6 ISNT ESPB

Arm Description

Atrial fibrillation. Serratus anterior plane block

Atrial fibrillation. Erector spinae plane block

Ventricular Tachycardia.Serratus anterior plane block

Ventricular Tachycardia. Erector spinae plane block

Inappropriate Sinus node tachycardia. Serratus anterior plane block

Inappropriate Sinus node tachycardia. Erector spinae plane block

Outcomes

Primary Outcome Measures

evaluate block placement efficacy in the hybrid surgery setting specifically time to placement in seconds
Time to placement in seconds
evaluate block placement efficacy in the hybrid surgery setting visualization time of location of injection by picturing
visualisation time of location of injection
evaluate block placement efficacy in the hybrid surgery setting adequacy of ropivacaine spread by picturing
Block placement efficacy by seeing the ropivacaine spread
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

Secondary Outcome Measures

Pain location
Place of pain: sternal; back, thorax, shoulder, throat, neck
Additional analgesic consumption and requests
Pain drugs used: paracetamol in grams, piritramide in milligrams, diclofenac in milligrams, aspirin in milligrams, colchicine in grams
Ease of breathing, breathing quality
Breathing evaluation: superficial, tense, normal, deep
Sleeping quantity
Number of hours slept after surgery
Duration hospital Stay
Length of hospital stay
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
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

Full Information

First Posted
December 2, 2019
Last Updated
April 26, 2023
Sponsor
Universitair Ziekenhuis Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT04868058
Brief Title
Serratus Anterior or Erector Spinae Block for Hybrid Arrhythmia Ablation Surgery
Official Title
Serratus Anterior Plane Block or Erector Spinae Plane Block Used as an Adjuvant for Hybrid Arrhythmia Ablation Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitair Ziekenhuis Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia
Keywords
Arrhythmia, Ablation, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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
ParticipantCare Provider
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1 AF SAPB
Arm Type
Experimental
Arm Description
Atrial fibrillation. Serratus anterior plane block
Arm Title
2 AF ESPB
Arm Type
Experimental
Arm Description
Atrial fibrillation. Erector spinae plane block
Arm Title
3 VT SAPB
Arm Type
Experimental
Arm Description
Ventricular Tachycardia.Serratus anterior plane block
Arm Title
4 VT ESPB
Arm Type
Experimental
Arm Description
Ventricular Tachycardia. Erector spinae plane block
Arm Title
5 ISNT SAPB
Arm Type
Experimental
Arm Description
Inappropriate Sinus node tachycardia. Serratus anterior plane block
Arm Title
6 ISNT ESPB
Arm Type
Experimental
Arm Description
Inappropriate Sinus node tachycardia. Erector spinae plane block
Intervention Type
Drug
Intervention Name(s)
Ropivacaine injection
Other Intervention Name(s)
Naropin
Intervention Description
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
Primary Outcome Measure Information:
Title
evaluate block placement efficacy in the hybrid surgery setting specifically time to placement in seconds
Description
Time to placement in seconds
Time Frame
Time to placement: 1200 seconds
Title
evaluate block placement efficacy in the hybrid surgery setting visualization time of location of injection by picturing
Description
visualisation time of location of injection
Time Frame
Visualisation is done by picturing to confirm adequate block (up 120 seconds)
Title
evaluate block placement efficacy in the hybrid surgery setting adequacy of ropivacaine spread by picturing
Description
Block placement efficacy by seeing the ropivacaine spread
Time Frame
picturing Confirms time of block placement (up to 300 seconds)
Title
Worst numerical scale pain in the first 12 h after admission to the post-anaesthesia care unit.
Description
Maximal pain assesed by visual analog scale ,where 0= no pain 10= maximal pain
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
Pain location
Description
Place of pain: sternal; back, thorax, shoulder, throat, neck
Time Frame
72 hours
Title
Additional analgesic consumption and requests
Description
Pain drugs used: paracetamol in grams, piritramide in milligrams, diclofenac in milligrams, aspirin in milligrams, colchicine in grams
Time Frame
72 hours
Title
Ease of breathing, breathing quality
Description
Breathing evaluation: superficial, tense, normal, deep
Time Frame
72 hours
Title
Sleeping quantity
Description
Number of hours slept after surgery
Time Frame
72 hours
Title
Duration hospital Stay
Description
Length of hospital stay
Time Frame
From 2 to 15 days
Title
Body Mass Index
Description
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
Time Frame
Will be assessed on screening day or exported up to 2 weeks before screening day.
Title
Ideal body weight
Description
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
Time Frame
Will be assessed on screening day or exported up to 2 weeks before screening day.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 - Exclusion Criteria: 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..
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vincent J Umbrain, MD, PhD
Phone
02 477 8962
Ext
0032
Email
vincent.umbrain@uzbrussel.be
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Poelaert, MD PhD
Phone
02 477 8962
Ext
0032
Email
jan.poelaert@uzbrussel.be
Facility Information:
Facility Name
Universitair Ziekenhuis
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Verborgh, MD PhD
Phone
04764773145
Ext
0032
Email
christian.verborgh@uzbrussel.be
First Name & Middle Initial & Last Name & Degree
Stefan Beckers, MD
Phone
04764763141
Ext
0032
Email
stefan.beckers@uzbrussel.be

12. IPD Sharing Statement

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Serratus Anterior or Erector Spinae Block for Hybrid Arrhythmia Ablation Surgery

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