- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04868058
Serratus Anterior or Erector Spinae Block for Hybrid Arrhythmia Ablation Surgery
Serratus Anterior Plane Block or Erector Spinae Plane Block Used as an Adjuvant for Hybrid Arrhythmia Ablation Surgery
Study Overview
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Vincent J Umbrain, MD, PhD
- Phone Number: 0032 02 477 8962
- Email: vincent.umbrain@uzbrussel.be
Study Contact Backup
- Name: Jan Poelaert, MD PhD
- Phone Number: 0032 02 477 8962
- Email: jan.poelaert@uzbrussel.be
Study Locations
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Brussel, Belgium, 1090
- Recruiting
- Universitair Ziekenhuis
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Contact:
- Christian Verborgh, MD PhD
- Phone Number: 0032 04764773145
- Email: christian.verborgh@uzbrussel.be
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Contact:
- Stefan Beckers, MD
- Phone Number: 0032 04764763141
- Email: stefan.beckers@uzbrussel.be
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
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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..
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1 AF SAPB
Atrial fibrillation.
Serratus anterior plane block
|
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
Other Names:
|
Experimental: 2 AF ESPB
Atrial fibrillation.
Erector spinae plane block
|
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
Other Names:
|
Experimental: 3 VT SAPB
Ventricular Tachycardia.Serratus anterior plane block
|
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
Other Names:
|
Experimental: 4 VT ESPB
Ventricular Tachycardia.
Erector spinae plane block
|
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
Other Names:
|
Experimental: 5 ISNT SAPB
Inappropriate Sinus node tachycardia.
Serratus anterior plane block
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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
Other Names:
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Experimental: 6 ISNT ESPB
Inappropriate Sinus node tachycardia.
Erector spinae plane block
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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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
evaluate block placement efficacy in the hybrid surgery setting specifically time to placement in seconds
Time Frame: Time to placement: 1200 seconds
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Time to placement in seconds
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Time to placement: 1200 seconds
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evaluate block placement efficacy in the hybrid surgery setting visualization time of location of injection by picturing
Time Frame: Visualisation is done by picturing to confirm adequate block (up 120 seconds)
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visualisation time of location of injection
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Visualisation is done by picturing to confirm adequate block (up 120 seconds)
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evaluate block placement efficacy in the hybrid surgery setting adequacy of ropivacaine spread by picturing
Time Frame: picturing Confirms time of block placement (up to 300 seconds)
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Block placement efficacy by seeing the ropivacaine spread
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picturing Confirms time of block placement (up to 300 seconds)
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Worst numerical scale pain in the first 12 h after admission to the post-anaesthesia care unit.
Time Frame: 12 hours
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Maximal pain assesed by visual analog scale ,where 0= no pain 10= maximal pain
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12 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain location
Time Frame: 72 hours
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Place of pain: sternal; back, thorax, shoulder, throat, neck
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72 hours
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Additional analgesic consumption and requests
Time Frame: 72 hours
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Pain drugs used: paracetamol in grams, piritramide in milligrams, diclofenac in milligrams, aspirin in milligrams, colchicine in grams
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72 hours
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Ease of breathing, breathing quality
Time Frame: 72 hours
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Breathing evaluation: superficial, tense, normal, deep
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72 hours
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Sleeping quantity
Time Frame: 72 hours
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Number of hours slept after surgery
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72 hours
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Duration hospital Stay
Time Frame: From 2 to 15 days
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Length of hospital stay
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From 2 to 15 days
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Body Mass Index
Time Frame: Will be assessed on screening day or exported up to 2 weeks before screening day.
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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
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Will be assessed on screening day or exported up to 2 weeks before screening day.
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Ideal body weight
Time Frame: Will be assessed on screening day or exported up to 2 weeks before screening day.
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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
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Will be assessed on screening day or exported up to 2 weeks before screening day.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAPB-ESPB hybrid AAS study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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