Interest of Serratus Plane Block in Postoperative Analgesia for Robot-assisted Surgery

Study Overview
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Brief Summary
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The aim of the study is to compare the analgesia provided by the serratus plane block with local infiltration of the orifices of the trocars after thoracic robot-assisted surgery.

Detailed Description
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In our hospital, the current practice to provide post operative analgesia for patients scheduled for robot-assisted mitral repair or oncological thoracic surgery is to dispense local anesthetics at the orifices of the trocars at the end of the surgery and to give a Patient Controlled Analgesia (PCA). Some of these patients are not comfortable and we observe a large percentage of chronic pain. Recently we tried to use the Serratus plane block realised before the beginning of the surgery, and it seemed that patients were more comfortable with a lower consumption of morphine. So we decided to perform a double blind, randomized study in this population of patients to compare the analgesia provided by the serratus plane block realized before the beginning of the surgery and the local infiltration of the wound at the end of the surgery.

Official Title
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Interest of Serratus Plane Block in Postoperative Analgesia for Patients Undergoing Robot-assisted Mitral Valve Repair, MIDCAB or Partial Lung Resection

Conditions
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Robotic Surgery, Analgesia

Intervention / Treatment
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* Drug: 0.5% levobupivacaine injectable solution with 10 ml of physiological saline
* Drug: 0.5% levobupivacaine injectable solution with 10 ml of physiological saline
* Drug: 0.5% levobupivacaine injectable solution with physiological saline
* Drug: 0.5% levobupivacaine injectable solution with physiological saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: mitral repair, coronary artery revascularization or thoracic surgery scheduled robot-assisted surgery Exclusion Criteria: non robot-assisted surgery

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
Interventional Model Description: Compare the efficacy of the serratus plane block with local infiltration after thoracic robot-assisted surgery
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: serratus<br>Serratus plane block and local control | Drug: 0.5% levobupivacaine injectable solution with 10 ml of physiological saline<br>* Serratus plane block realized with a mixture of 10 ml of 0.5% levobupivacaine injectable solution with 10 ml of physiological saline<br>* Other names: serratus plane block;Drug: 0.5% levobupivacaine injectable solution with physiological saline<br>* local infiltration of the wound with 20 ml of injectable solution of physiological saline<br>* Other names: local control;|
| Sham Comparator: local<br>serratus control and local anesthesia | Drug: 0.5% levobupivacaine injectable solution with 10 ml of physiological saline<br>* local infiltration of the wound with a mixture of 10 ml of 0.5% levobupivacaine injectable solution with 10 ml of physiological saline<br>* Other names: local anesthesia;Drug: 0.5% levobupivacaine injectable solution with physiological saline<br>* Serratus plane block realized with 20 ml of injectable solution of physiological saline<br>* Other names: local serratus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| D0 pain intensity | Self reported pain intensity the day of surgery. Each item is scored 0-100 (0 - no pain, 100 - pain as bad as can be) | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| D1 pain intensity | Self reported pain intensity the days after surgery. Each item is scored 0 - 100 (0 - no pain, 100 - pain as bad as can be) | 3 days | 
| morphine consumption | Consumption of morphine the day and 4 days after surgery as recorded on the PCA. | 5 days | 
| persistence of a chronic pain | Phone call 3 month after surgery to evaluate the persistence of pain | 3 months |