Regional Anesthesia for Breast Surgery

Study Overview
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Brief Summary
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Patients scheduled for mastecotmy will be randomized to receive either an ultrasound-guided double space paravertebral block or a PECSII + parasternal block. In both groups, blocks will be performed with 20 ml of ropivacaine 0.75%, plus ropivacaine 0.375% 10 ml for parasternal block only. Postoperative, all patients will receive a morphine PCA. They will follow at 6, 12, 24 months for persistent postoperative surgical pain (PPSP) and cancer recurrence.

Detailed Description
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Patients scheduled for mastecotmy with or without axillary dissection, will be randomized to receive preoperative either an ultrasound-guided double space paravertebral block or a PECSII + parasternal block. In both groups, blocks will be performed with 20 ml of ropivacaine 0.75%, plus ropivacaine 0.375% 10 ml for parasternal block only. All the patients also received a general anesthesia induced by propofol and esmeron for endotracheal intubation and desflurane for maintaining. Sensory block by ice and pinprick test application and maximum spread after 40' from LA injection will be registered. Postoperative, all patients will receive a morphine PCA, ketorolac 30 mg/12h and paracetamol 1g each 8h. Morphine consumption will be registered. Patients will follow at 6, 12, 24 months for persistent postoperative surgical pain (PPSP) and cancer recurrence.

Official Title
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A Prospective, Randomized Comparison Between Paravertebral and Pectoral Nerve Block on Postoperative Pain, Persistent Post Surgical Pain and Cancer Recurrence After Mastectomy

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: PECSII and paravertebral blocks


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for radical mastectomy for cancer. age > 18 y-o Written informed consent Exclusion Criteria: Bilateral surgery Opioids user BMI > 35 Postoperative Intensive care

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: pectoral PECS II block<br>Ultrasound-guided PECS II block with ropivacaine 0.75% 20 ml (patients N = 75) + Parasternal ultrasound-guided block at T2, T4 levels with ropivacaine 0.375% 10 ml | Procedure: PECSII and paravertebral blocks<br>* Regional anesthesia for mastectomy outcomes<br>|
| Active Comparator: Paravertebral nerve block<br>Ultrasound-guided paravertebral block with ropivacaine 0.75% 20 ml at T1-T2 and T3-T4 levels (10 ml each) (patients N = 75) | Procedure: PECSII and paravertebral blocks<br>* Regional anesthesia for mastectomy outcomes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine requirement | Morphine self-administered by a patient controlled device | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain | Pain reporter by a numerical rating scale (NRS) 0-10 (0=no pain, 10=the worst imaginable pain) postoperatively | 2 days | 
| Persistent Postsurgical pain (PPSP) | Pain reported by a a numerical rating scale (NRS) 0-10 (0=no pain, 10=the worst imaginable pain) in the follow up | 2 years | 
| cancer recurrence | Incidence of cancer recurrence | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, regional anesthesia, cancer recurrence