Serratus Anterior Plane Block or Erector Spinae Plane Block Used as an Adjuvant for Hybrid Arrhythmia Ablation Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- evaluate block placement efficacy in the hybrid surgery setting visualization time of location of injection by picturing
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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..
Arms & Interventions
1 AF SAPB
Atrial fibrillation. Serratus anterior plane block
Intervention: Ropivacaine injection (Drug)
2 AF ESPB
Atrial fibrillation. Erector spinae plane block
Intervention: Ropivacaine injection (Drug)
3 VT SAPB
Ventricular Tachycardia.Serratus anterior plane block
Intervention: Ropivacaine injection (Drug)
4 VT ESPB
Ventricular Tachycardia. Erector spinae plane block
Intervention: Ropivacaine injection (Drug)
5 ISNT SAPB
Inappropriate Sinus node tachycardia. Serratus anterior plane block
Intervention: Ropivacaine injection (Drug)
6 ISNT ESPB
Inappropriate Sinus node tachycardia. Erector spinae plane block
Intervention: Ropivacaine injection (Drug)
Outcomes
Primary Outcomes
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)
visualisation time of location of injection
Worst numerical scale pain in the first 12 h after admission to the post-anaesthesia care unit.
Time Frame: 12 hours
Maximal pain assesed by visual analog scale ,where 0= no pain 10= maximal pain
evaluate block placement efficacy in the hybrid surgery setting specifically time to placement in seconds
Time Frame: Time to placement: 1200 seconds
Time to placement in seconds
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)
Block placement efficacy by seeing the ropivacaine spread
Secondary Outcomes
- 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)
- Body Mass Index(Will be assessed on screening day or exported up to 2 weeks before screening day.)
- Ideal body weight(Will be assessed on screening day or exported up to 2 weeks before screening day.)