Efficacy Between Serratus Plane Block And Local Infiltration In Vats

Study Overview
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Brief Summary
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Robotic video-assisted thoracoscopic surgery (VATS) is increasingly being used as it is a less invasive surgery compared to traditional methods, but the acute pain at an early stage after VATS has a major impact on perioperative outcomes. Effective post operative analgesia is believed to reduce morbidity, quicken recovery, improve patient outcome and reduce hospital costs. The site and extent of the incision influences the degree of pain due to disruption of intercostal nerves as well as inflammation of chest wall and pleura. Neuraxial and systemic opioids have been a gold standard as a part of multimodal analgesia for thoracic surgeries. Numerous modalities have been studied: thoracic paravertebral nerve blocks, thoracic epidural analgesia, intercostal nerve blocks, patient controlled analgesia (PCA), cryo-analgesia, transcutaneous electrical nerve stimulation (TENS), inter-pleural blocks, stellate ganglion blocks, long thoracic nerve blocks, and infiltration under direct vision by the surgeon. Serratus plane block is an emerging regional technique that has proven to be effective in comparison to paravertebral blocks in patients undergoing breast surgery and mastectomy with reduced perioperative opioid consumption and improved pain scores. The lateral pectoral nerve, medial pectoral nerve, intercostal nerves and long thoracic nerve are all targets for the serratus plane block. It can be safely performed under ultrasound guidance. The purpose of the study is to evaluate the difference in quality of analgesia between efficacy of serratus plane block and local surgical infiltration by surgeon as measured by patient opioid consumption and pain scores.

Detailed Description
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Participants will be assigned randomly using a computer-generated table of numbers to either serratus group or infiltration group. Block team will perform all blocks.

Official Title
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Comparison Between Serratus Plane Block And Local Surgical Infiltration In Robotic Video Assisted Thoracoscopic Surgery- A Randomised Controlled Trial

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: Bupivacaine
* Drug: Bupivacaine liposome


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA (American Society of Anesthesiology) class I-IV age 81-75 Exclusion Criteria: ASA class V morbid obesity patient refusal patients with chronic pain or on pain medications allergy to LA patients receiving any additional regional techniques coagulopathy patients receiving systemic anticoagulation local infection procedures anticipated to last more than 5 hours.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Serratus Plane Group<br>Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound. | Drug: Bupivacaine<br>* 20 cc 0.5%<br>Drug: Bupivacaine liposome<br>* 133mg liposomal bupivacaine<br>|
| Placebo Comparator: Placebo Group<br>Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice. | Drug: Bupivacaine liposome<br>* 133mg liposomal bupivacaine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of Opioid Consumption | The amount of opioid consumption (in mg IV morphine equivalents) postoperatively up to 24 hours after the procedure. | up to 24 hours post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Dose of Narcotic Administration | Time to first dose of narcotic administration post procedure | up to 24 hours post procedure | 
| PACU Length of Stay | The length of stay post procedure in the PACU | average 3-4 hours post procedure | 
| ICU Length of Stay | The length of stay post procedure in the or ICU | up to 40 hours post procedure | 
| Visual Analogue Score (VAS) | Visual Analogue Score (VAS) pain score from 0 (no pain) to 10 (most pain) | up to 24 hours post procedure | 
| Patient Satisfaction Score | Patient satisfaction score from 0 (not satisfied) to 10 (extremely satisfied) | up to 24 hours post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Video assisted thoracoscopic surgery, Serratus plane block, local infiltration