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

SAPB-ESPB hybrid AAS study

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.

2019-11-01

2024-12-01

2024-12-01

Recruiting

132

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..

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'This clinical investigation is an interventional uni-center, prospective, open, randomized, double arm, blinded to the pain physician and the patient, clinical evaluation', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 132, 'type': 'ESTIMATED'}}

2023-04-27