PVB vs PECS Block in Breast Surgery

Study Overview
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Brief Summary
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Purpose to compare paravertebral thoracic block (PVB) and pectorals nerves block as analgesic option for major breast surgery. 102 patients undergoing reconstruction breast surgery will be randomized into two groups: Group PVB (n=51) will receive US guided paravertebral thoracic block (between T2-T6) performed with 30ml of 0.25% levobupivacaine before general anesthesia (TCI-TIVA) induction. Morphine patient control analgesia (PCA) with loading dose i.v. titrated by the PACU nurse if pain > 5/10 at rest Group PECS (n=51) will receive US guided pectorals nerves block performed with 30ml of 0.25% levobupivacaine before general anesthesia (TCI-TIVA) induction. Morphine PCA with loading dose i.v. titrated by the post-anesthesia care unit (PACU) nurse if pain > 5/10 at rest Primary Outcome Measures: Morphine consumption (mg) (Time Frame: 24 hours) in two Groups Secondary Outcome Measures: Pain at rest and during movement quantified as Numerical Rating Scores (0-10) during the first 24 hours postoperatively. Eventual side effects such as nausea/vomiting. Time necessary to perform the procedure. Pain during procedure execution quantified as Numerical Rating Scores (0-10) Hypnotic and opioids intraoperative consumption to ensure general anesthesia with Bispectral Index between 40 and 60.

Official Title
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Thoracic Paravertebral Block Versus Pectoral Nerves Block (Modified PECS) Block in Breast Surgery

Conditions
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Reconstruction Breast Surgery

Intervention / Treatment
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* Procedure: Paravertebral Thoracic block
* Procedure: Pectorals nerve block
* Drug: Levobupivacaine 0.25%
* Drug: Morphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age> 18 years ASA score I - II - III undergoing elective reconstruction breast surgery signed informed consent Exclusion Criteria: chronic therapy with opioids/ antidepressants urgent/emergent surgery postoperative transfer to the intensive care unit known allergy to any drug medication local skin infection epilepsy alcohol or drug abuse

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PVB<br>51 patients receiving US guided homolateral paravertebral thoracic block with 30ml of 0.25% levobupivacaine, before general anesthesia (TCI-TIVA). | Procedure: Paravertebral Thoracic block<br> <br> Drug: Levobupivacaine 0.25%<br> <br> Drug: Morphine<br> <br> |
| Experimental: PECS<br>51 patients receiving US guided pectorals nerve block with 30ml of 0.25% levobupivacaine, before general anesthesia (TCI-TIVA). | Procedure: Pectorals nerve block<br> <br> Drug: Levobupivacaine 0.25%<br> <br> Drug: Morphine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCA morphine consumption in the two groups within the first 24 postoperative hours |  | 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Rating Scores for pain at rest and during movement |  | 24 hours postoperatively | 
| Postoperative nausea/vomiting incidence |  | 24 hours postoperatively | 
| Time of performance |  | During procedure execution | 
| Propofol consumption in intraoperative period | Propofol consumption in intraoperative period to maintain total intravenous general anesthesia (BIS target 40-60). Propofol consumption in mg/kg/h | Intraoperative period | 
| Opioids (remifentanyl) consumption in intraoperative period | Opioids (remifentanyl) consumption in intraoperative period to maintain total intravenous general anesthesia (systolic blood pression target: reduction of 20% from base line value). Remifentanyl in mcg/kg/h | Intraoperative period | 
| Numerical Rating Scores during procedure execution |  | During procedure execution |