Serratus Anterior or Erector Spinae Block for Hybrid Arrhythmia Ablation Surgery

Arrhythmia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04868058
• Other study ID #: SAPB-ESPB hybrid AAS study
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: December 1, 2024

Study information

• Verified date: April 2023
• Source: Universitair Ziekenhuis Brussel
• Contact: Vincent J Umbrain, MD, PhD
• Phone: 02 477 8962
• Email: vincent.umbrain[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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..

Related Conditions & MeSH terms

• Arrhythmia
• Arrhythmias, Cardiac

Intervention

Drug:
• Ropivacaine injection
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

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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)
Primary	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	Pain location	Place of pain: sternal; back, thorax, shoulder, throat, neck	72 hours
Secondary	Additional analgesic consumption and requests	Pain drugs used: paracetamol in grams, piritramide in milligrams, diclofenac in milligrams, aspirin in milligrams, colchicine in grams	72 hours
Secondary	Ease of breathing, breathing quality	Breathing evaluation: superficial, tense, normal, deep	72 hours
Secondary	Sleeping quantity	Number of hours slept after surgery	72 hours
Secondary	Duration hospital Stay	Length of hospital stay	From 2 to 15 days
Secondary	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	Will be assessed on screening day or exported up to 2 weeks before screening day.
Secondary	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	Will be assessed on screening day or exported up to 2 weeks before screening day.