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Logistic reasons (Operating room performing the surgery investigated moved to another structure)
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESP BLOCK | Active Comparator | 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) |
|
| PECS block | Active Comparator | Intervention:30 ml of 0.25% Levobupivacaine where:PECS II block as described by Blanco. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESP BLOCK | Procedure | local anesthetic will be injected between transverous process and erector spinae muscle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative Fentanyl consumption | Intraoperative fentanyl dose (mcg) difference between ESP group and PECS group. | Intraoperative |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alessandro De Cassai, MD | Department of Medicine, DIMED - Section of Anesthesiology and Intensive Care. University of Padova | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Padova | Padova | Veneto | 35127 | Italy |
Probably data will be shared at the end of the study
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077554 | Levobupivacaine |
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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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.
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ESP block and PECS block will be executed by an anesthesiologist that will not follow the patient during the surgery.
Anesthesiologist responsible for the surgery will be not aware of the block executed on the patient Anesthesiologist and surgeon responsible for postoperative therapy will be not aware of the block executed on the patient
| PECS BLOCK | Procedure | local anesthetic will be injected between pectoralis minor and pectoralis major (10 ml) and between pectoralis minor and serratus (20 ml) |
|
|
| 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 |
| D017437 |
| Skin and Connective Tissue Diseases |
| Aniline Compounds |
| D000588 | Amines |