Comparison of Erector Spinae Plane Block With PECS II Block in Patients Undergoing Breast Cancer Surgery

Study Overview
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Brief Summary
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Backgroung:Regional anesthesia in breast surgery is of paramount importance to reduce pain in perioperative period. PECS II block is an interfascial block that has been used widely as regional anesthesia technique in breast surgery. ESP block is a novel interfascial block proposed in 2016 by Forero. Several reports used this technique in breast surgery to provide analgesia but to date no studies comparing these technique exists. Our hypotesis is that this two technique are equally able to provide analgesia in breast surgery. Study type: RCT, single blind.

Official Title
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Comparison of Erector Spinae Plane Block With PECS II Block in Patients Undergoing Breast Cancer Surgery:a Randomized Controlled Trial

Conditions
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Breast Cancer, Anesthesia, Local

Intervention / Treatment
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* Procedure: ESP BLOCK
* Procedure: PECS BLOCK


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mastectomy program with axillary clearence Exclusion Criteria: bilateral surgery

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a single-centre, prospective; double blinded randomised interventional clinical trial. Patients will be randomly allocated to group PECS or ESP using a closed envelope technique. Group PECS will receive PECS II block as described by Blanco using 30 ml Levobupivacaine 0.25% Group ESP will receive ESP block as described by forero using 30 ml Levobupivacaine 0.25% at T5 level. Blocks will be executed after general anesthesia induction. All partecipants will receive Fentanyl 2 mcg/kg and Propofol 2 mg/kg for induction. Anesthesia will be mantained with Propofol to obtain a BIS level between 40-50. Patients will receive Fentanyl 33 mcg whenever blood pressure and/or hear rate raise more than 20% from baseline after surgical stimulation. At the end of the surgery patients will receive acetominophen 1 g. postoperative therapy: acetominophen 1g/8hr and ketoprofen 100 mg/12hr. Patients will receive 2 mg Morphine whenever a NRS > 3.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ESP BLOCK<br>Intervention:30 ml of 0.25% Levobupivacaine where: ESP block as described by Forero at T5 level (single injection between transversour process and erector spinae muscles) | Procedure: ESP BLOCK<br>* local anesthetic will be injected between transverous process and erector spinae muscle<br>|
| Active Comparator: PECS block<br>Intervention:30 ml of 0.25% Levobupivacaine where:PECS II block as described by Blanco. | Procedure: PECS BLOCK<br>* local anesthetic will be injected between pectoralis minor and pectoralis major (10 ml) and between pectoralis minor and serratus (20 ml)<br>* Other names: 30 ml 0.25% Levobupivacaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative Fentanyl consumption | Intraoperative fentanyl dose (mcg) difference between ESP group and PECS group. | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS at 6 hour | NRS (0-10) difference at sixth postoperative hour between ESP group and PECS group | sixth postoperative hour | 
| NRS at 12 hour | NRS (0-10) difference at twelth postoperative hour between ESP group and PECS group | twelth postoperative hour | 
| NRS at 24 hour | NRS (0-10) difference at twentyfourth postoperative hour between ESP group and PECS group | twentyfourth postoperative hour | 
| Patient satisfaction at 24 hour | Patient satisfaction (0-10) difference regarding anesthesia management at twentyfourth postoperative hour between ESP group and PECS group | postoperative period (24h) | 
| Time to first opioid consumption in the postoperative period | Time (minutes) to first opioid consumption in the postoperative period | postoperative period (24h) | 
| Postoperative morphine consumption | postoperative morphine dose (mg) difference between ESP group and PECS group. | postoperative period (24h) | 
| Nausea and vomit incidence | Incidence of nausea and vomiting in postoperative period | postoperative period (24h) | 
| Other complication incidence | Incidence of other complcations linked to anesthesia in postoperative period | postoperative period (24h) | 
| Intraoperative Fentanyl consumption(mcg/kg/h) | Intraoperative fentanyl dose (mcg/kg/h) difference between ESP group and PECS group. | Intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PECS, ESP, RCT