SERRATHOR TRIAL : Interest of the Novel Serratus Plane Block in Post Operative Analgesia After Video-Assisted Thoracoscopic Lobectomy

Study Overview
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Brief Summary
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Pain after thoracic surgery remains a challenge for anesthetists. Although VATS for lobectomy is associated with fewer complications compared to thoracotomy, pain after VATS needs to be treated with opioids. Opioids may lead to PONV, respiratory depression, sedation and pruritus. As part of multimodal analgesia and opioids sparing, several local regional techniques has been described: paravertebral block, thoracic epidural analgesia, intercostal block. To date, there is no gold standard for regional anesthesia after VATS. Serratus plane block is a local regional technique, recently described for analgesia after breast surgery and ribs fracture. In our hospital center, since 2016, we used the Serratus plane block for patients scheduled for lobectomy VATS : a local retrospective trial showed that SPB was associated with a lower consumption of morphine. The purpose of this randomized controlled double blinded study is to evaluate the analgesic effect of the Serratus plane block, added to a general anesthesia on post operative pain control after VATS lobectomy.

Official Title
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SERRATHOR Trial : Analgesic Effect of Serratus Plane Block After Video-Assisted Thoracoscopic Surgery Lobectomy

Conditions
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Video Assisted Thoracoscopic Surgery, Lobectomy, Pain Post Operative, Regional Anesthesia

Intervention / Treatment
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* Drug: Ropivacaine
* Drug: sterile saline


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: All patients undergoing lobectomy VATS Older > 18 years Patients who meet criteria of ASA 1 to 3 class Exclusion criteria: Patient's refusal to participate in the study Psychiatric disorder (impossibility to collect the informed consent) Patient under juridical protection On going an other study Non balanced epilepsy 3 grade auriculo-ventricular heart block without pacing Severe hepatocellular insufficiency Anti arrhythmic treatment : class III of the Vaughan William's classification Pregnant patient or/and breastfeeding History of opioid abuse Allergy to local anesthetic drug or opioids

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Serratus Block<br>At the end of the lobectomy VATS procedure, 0,5 mL/kg of 0.375% ropivacaine will be administered. Under ultrasonography assistance, block will be performed at the fifth rib in the midaxillary line. Local anesthetic will be injected either superficial to the serratus anterior muscle or deep underneath the muscle. Anesthesiologists, and all the nurses and caring staff involved in this study will be blinded. Solutions of ropivacaine will be prepared identically by the central pharmacy, without any possible identification of the product. | Drug: Ropivacaine<br>* At the end of the lobectomy VATS procedure, 0,5 mL/kg of 0.375% ropivacaine will be administered.<br>|
| Placebo Comparator: Placebo Block - Control Group<br>Patients will receive a placebo injection with 0,5 mL/kg of sterile normal solution. Under ultrasonography assistance, placebo will be injected at the fifth rib in the midaxillary line, either superficial to the serratus anterior muscle or deep underneath the muscle. Anesthesiologists, and all the nurses and caring staff involved in this study will be blinded. Solutions of sterile saline will be prepared identically by the central pharmacy, without any possible identification of the product. | Drug: sterile saline<br>* Patients will receive a placebo injection with 0,5 mL/kg of sterile normal solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total intravenous morphine consumption (mg) in the PACU and department. | Including the dose of titration while the patient is in PACU and PCA up to 24h postoperatively. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Serratus plane block, Analgesia after VATS, Lobectomy VATS