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The main objectives of the trial are the efficacy and safety of intercostal nerve block in the midaxillary line versus paravertebral block, both guided by ultrasound in patients scheduled for not reconstructive breast surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BRILMA&dexketoprofen¶cetamol | Experimental | dexketoprofen: 50 mg/8h paracetamol: 1gr/6h |
|
| paravertebral block&dexketoprofen¶cetamol | Active Comparator | dexketoprofen: 50 mg/8h paracetamol: 1g/6h |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BRILMA | Procedure |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| pain score: verbal simple scale | admission to post-anesthesia care unit (PACU) | 0,3,6,12,18 and 24h |
| pain score: visual number scale | post-admission to PACU | 0, 3, 6,12, 18, 24h |
| opioid requirements | 0 dose/ 1 dose/ 2 or more doses | 24 h |
| sleep quality | bad/regular/good | 24 h |
| amount of sleep | < 3h/ 3-6h, >6h | 24 h |
| Measure | Description | Time Frame |
|---|---|---|
| percentage of participants with nausea and vomiting | without symptoms/ nausea/vomiting/ both symptoms | 24 hours |
| Number of Participants with Serious and Non-Serious Adverse Events | directly due to block nerve and general complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paula Diéguez, Anesthesiologist | Contact | pauladieguez@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Abente y Lago. Complejo Hospitalario Universitario A Coruña | Recruiting | A Coruña | 15006 | Spain |
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| ID | Term |
|---|---|
| C118296 | dexketoprofen trometamol |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| paravertebral block |
| Procedure |
|
| dexketoprofen | Drug |
|
| paracetamol | Drug |
|
| 24 h |
| Aniline Compounds |
| D000588 | Amines |