Continuous Serrates Plane Block in Axillary Dissection

Study Overview
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Brief Summary
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Patients undergone to axillary dissection during breast surgery with a PECS I, II block will be randomized to receive either a serratus plane continuous local anesthetic infusion through a multiple hole catheter or nothing. Both groups will receive a patient controlled analgesia with morphine.

Detailed Description
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84 patients ASA I-III undergoing breast surgery with axillary dissection after modified PECS II block as described by Blanco et al. with Ropivacaine 0.37% 30 ml. General anesthesia with remifentanil 0.1 mcg/Kg/min and Propofol 1.5-2 mg/Kg to facilitate endotracheal intubation will provide for all patients, and maintained with Desflurane and Remifentanil infusion. In case of axillary dissection patient will be randomized to receive either a serratus plane continuous local anesthetic infusion through a multiple hole catheter or nothing. Both groups will receive as intraoperative analgesia 1 g Acetaminophene ev 30 minute before the end of the surgery and 1g. 8h-1 postoperative associated to a patient controlled analgesia with morphine. PCA will set up as follow: bolus 1 mg, lock-out 6 minute, max 20 mg/4h. In the serratus group 10 ml of Ropivacaine 0.5% before fascial closure and a continuous infusion of 12 ml/h of Ropivacaine 0.2% will be provide.

Official Title
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Continuous Serratus Plane Block Added to PECS II vs PECS II Alone for Post Operative Analgesia After Axillary Dissection in Breast Cancer Surgery

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Continuous serratus plane block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age > 18 breast surgery informed consent Exclusion Criteria: ASA >3 allergy to local anesthetic opioid administration in the last month patient refusal

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: serratus catheter<br>Continuous serratus plane block: Ropivacaine 0.2% infusion through a multiple hole catheter (C-Cat Cimpax Denmark)at a fixed dose of 12 ml/h and a multimodal analgesia with acetaminophen and a PCA of morphine | Procedure: Continuous serratus plane block<br>* Peripheral nerve catheter placed by the surgeon at the end of surgery<br>|
| No Intervention: standard treatment<br>Post-operative multimodal analgesia with Acetaminophen and PCA of Morphine | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine consumption | A 70% reduction in morphine consumption in the continuous serratus plane block over control | 12-48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| persistent post-surgical pain: numerical rating scale | a numerical rating scale (0-10, 0= no pain, 10 = worst imaginable pain),> 4 | 3-6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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regional anesthesia