Bi-level vs. Single Level ESB in VATS

Study Overview
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Brief Summary
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Video assisted thoracoscopic surgery (VATS) is a minimally invasive surgery to remove lesions from the thoracic cavity. It is associated with moderate pain which can lead to pulmonary complications after surgery. The Enhanced Recovery After Surgery (ERAS) and the European Society of Thoracic Surgeons recommended a multimodal analgesia approach to manage pain after VATS. Erector spinae block (ESB) is a popular analgesic block due to its ease of performance and wide coverage. It has been shown to be effective in randomized control trials. Recently, case reports on bi-level ESB are emerging, suggesting more effective analgesia compared to single level ESB. As there is no available data, the investigators are interested in conducting a randomized pilot study, comparing bi-level to single level ESB to gather baseline data for sample size calculation for a formal randomized trial.

Official Title
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The Analgesic Efficacy of Bi-level Versus Single Level Erector Spinae Block in Video Assisted Thoracoscopic Surgery: a Randomized Patient Blinded Study

Conditions
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Acute Pain

Intervention / Treatment
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* Procedure: Bi-level erector spinae block
* Procedure: Single level erector spinae block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients (at least 18 years old) elective unilateral wedge resection, segmentectomy, lobectomy or bilobectomy via VATS Exclusion Criteria: history of malignant hyperthermia BMI > 40, chronic pain condition Daily opioid consumption of more than 60 mg oral morphine equivalents Conversion to thoracotomy Insertion of epidural postoperative admission to ICU

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single level block arm - Control<br>Single level erector spinae block at 4th transverse process | Procedure: Single level erector spinae block<br>* erector spinae block at 4th transverse process<br>|
| Experimental: Bi-level block arm - Intervention<br>Bi-level erector spinae block at 4th and 6th transverse process | Procedure: Bi-level erector spinae block<br>* erector spinae block at 4th and 6th transverse process<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid use in first 12 postoperaive hour |  | First 12 hour from arriving at postoperative recovery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score area under curve first 12 hour | Numeric rating scale, 0 to 10, 0 being no pain and 10 being the worst possible pain | First 12 hour from arriving at postoperative recovery | 
| Pain score area under curve first 24 hour | Numeric rating scale, 0 to 10, 0 being no pain and 10 being the worst possible pain | First 24 hour from arriving at postoperative recovery | 
| Incidence of Acute block complication - based on clinical assessment | pneumothorax, local anesthetic toxicity, epidural spread, bleeding | First 12 hour since block placement | 
| Incidence of Delayed block complication - based on clinical assessment | paresthesia, motor weakness, hematoma, abscess | First 5 days |