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To evaluate whether a serratus anterior plane block (SAPB) is more effective than a local infiltration anesthesia (LIA) with an equal dose and same anesthetic performed by the surgeon, as an adjuvant to treat postoperative pain after unilateral mastectomy.
To evaluate whether a serratus anterior plane block (SAPB) is more effective than a local infiltration anesthesia (LIA) with an equal dose and same anesthetic performed by the surgeon, as an adjuvant to treat postoperative pain after unilateral mastectomy.
Primary endpoint: the use of opioid's in the postoperative period. Secondary endpoint: Numerical Pain Rating Scale (NPRS) score recorded at the 2nd, 8th, 16th, 24th hour after surgery. 0 means no pain and 10 is the worst pain imaginable. In addition at the same time, we will look to the degree of arm mobilization where there will be 3 possible groups: 1. restricted, 2. fair mobilization and 3. free mobilization.
There are 2 treatment arms: 1st arm is the standard therapy, namely the local infiltration anesthesia. 2nd arm is the experimental arm, namely the SAPB. Patients are randomised into each arm after screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Local infiltration anesthesia | Active Comparator | Patients will receive local infiltration anesthesia with ropivacaine placed by surgeon. |
|
| Serratus anterior plane block | Experimental | Patients receive a SAPB with ropivacaine placed by anesthesiologist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAPB | Procedure | local anesthetic is injected between the serratus anterior and latissimus dorsi muscles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The use of opioids in the postoperative period | Patients receive a patient controlled intravenous anesthesia pump with morphine. We will be able to analyze the total amount of opioid requested by the patient. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Pain Rating Scale | Patients will be asked at 4 different time points the amount of pain they are feeling on a scale of 0 to 10. 0 meaning no pain and 10 meaning the worst pain imaginable. | 24 hours |
| Degree of arm mobilization |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Brussel | Jette | Brussels Capital | 1090 | Belgium |
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| Local Injection Anesthesia | Procedure | Anesthesia is injected directly into the tissue that is will be numbing. |
|
How much can the arm be mobilized of the patients? 3 groups: 1: restricted, 2: fair mobilization and 3. free mobilization
| 24 hours |
| ID | Term |
|---|---|
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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