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The study aims to compare the efficacy of the two operating blocks PECS2 and ESP by measuring postoperative opioid consumption and, secondarily, to compare (between PECS and ESP) postoperative opioid consumption between surgery with/without axillary cavity dissection and with/without implantation of prosthesis or expansion
Breast cancer is the most frequent type of cancer in the female population. Early detection is the most effective tool for improving prognosis, and the surgical approach plays a central role in the treatment of this disease. However, many are the psychophysical implications that patients face: among the main ones is postoperative and chronic pain, a symptom that greatly worsens the quality of life.
In the last decade it has been witnessed an important development of locoregional anesthesia techniques in all surgeries. In breast surgery, particularly mastectomy, the following locoregional anesthesia techniques are referred to as the Gold Standard:
By comparing postoperative opioid consumption between the two groups of patients, divided into PECS Block and ESP Block, the study aims to identify which anesthesia block is most effective in order to improve the care of patients undergoing mastectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PECS BLOCK 2 | Active Comparator | PECS 2 (or modified PECS) is a block that involves the administration of local anesthetic under ultrasound guidance between the great pectoral and small pectoral and between the small pectoral and serratus anterior. |
|
| ESP BLOCK | Experimental | ESP block is a block that involves injection of local anesthetic below the elevator muscles of the spine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PECS BLOCK 2 | Procedure | With the patient supine, the linear probe will be placed in the sagittal plane slightly lateral to the hemiclavicular line ipsilateral to the surgical site. Once both muscle planes of interest have been identified, in-plane needle insertion will proceed in the cranio-caudal direction. The first local anesthetic administration with Ropivacaine 0.5% will be 20ml between small pectoralis and serratus anterior. Coming out with the needle, 10ml of Ropivacaine 0.5% will then be injected between large and small pectoral. |
| Measure | Description | Time Frame |
|---|---|---|
| Morphine equivalent consumption in the postoperative 24h in simple mastectomies | Morphine-equivalent consumption in the postoperative 24h that patients self-administer between the group of patients undergoing ESP and those undergoing PECS 2 in simple mastectomies. | Postoperative 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Morphine-equivalent consumption in the postoperative 24h in mastectomies with axillary cavity emptying | Morphine-equivalent consumption in the postoperative 24h that patients self-administer between the group of patients undergoing ESP and those undergoing PECS 2 in mastectomies with axillary cavity emptying. | Postoperative 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mirco Leo, Physician | Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo | Alessandria | Piedmont | 15121 | Italy |
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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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| ESP BLOCK | Procedure | Positioning yourself behind the patient, lying on her side with the surgical hemilateral on top, you place the linear ultrasound probe in the sagittal plane and find the lateral margin of the transverse process. At this point, the blocking needle is inserted in the caudocranial direction and 25ml of Ropivacaine 0.5% is injected, taking care to visualize the anesthetic spread in the cranial direction. |
|
| Morphine-equivalent consumption in the postoperative 24h in mastectomies with prosthesis or expander placement |
Consumption of morphine equivalents in the postoperative 24h that patients self-administer between the group of patients undergoing ESP and those undergoing PECS 2 in astecctomies with prosthesis or expander placement. |
| Postoperative 24 hours |
| Morphine-equivalent consumption in the postoperative 24h in mastectomies with axillary cavity emptying and implantation of prosthesis or expander | Consumption of morphine equivalents in the postoperative 24h that patients self-administer between the group of patients undergoing ESP and those undergoing PECS 2 in mastectomies with axillary cavity emptying and implantation of prosthesis or expander | Postoperative 24 hours |
| PONV (Post Operating Nausea and Vomiting) | Number of times the patient experienced nausea or vomiting | Immediately after the surgery and at 2-4-8-12-24 hours after surgery |
| Complications incidence | Number of times the patient experienced complications such as bleeding or pneumothorax | Postoperative 24 hours |
| Time from end of surgery to first walk | Time in hours | Postoperative 72 hours |
| Length of hospitalization | Lenght in days | Up to 7 days |
| Patient's Likert Scale | Patient satisfaction, from 1 - Strongly disagree to 5 - Strongly agree | Postoperative 24 hours |
| Surgeon's Likert scale | Surgeon satisfaction, from 1 - Strongly disagree to 5 - Strongly agree | Postoperative 24 hours |
| D017437 |
| Skin and Connective Tissue Diseases |