Intercostal Nerves Block in the Midaxillary Line Versus Paravertebral Block for no Reconstructive Breast Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Intercostal Nerves Block in the Midaxillary Line Versus Paravertebral Block, Ultrasound Guided Blocks for no Reconstructive Breast Surgery. Randomized Trial

Conditions
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no Reconstructive Breast Surgery

Intervention / Treatment
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* Procedure: BRILMA
* Procedure: paravertebral block
* Drug: dexketoprofen
* Drug: paracetamol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for not reconstructive unilateral breast surgery. Physical status American Society Anesthesiologists (ASA) I-III. Signed informed consent. Aged between 18 and 75 years. Ability to assess pain using a verbal and numerical scales. Assessment of pain at the time of inclusion in the study is lower than 3 verbal simple scale Exclusion Criteria: Personal history of disorders of hemostasis or previous history of abnormal bleeding evidence. Local infection at the site of the puncture or to puncture prior systemic. Contraindications to study medication. Muscle or neurological disease, peripheral or central. Patients with prior history of opioid. Pregnancy or lactation. Difficulties in assessing pain or inability to understand or assist in the development of the study (psychiatric illness, cognitive impairments) Active Chronic alcoholism or drug addiction. BMI under 20 or mayor 30. Chronic treatment with non-steroidal anti-inflammatory drugs, antidepressants, anticonvulsants or opioids. Rejection of the patient

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BRILMA&dexketoprofen&paracetamol<br>dexketoprofen: 50 mg/8h paracetamol: 1gr/6h | Procedure: BRILMA<br> <br> * Other names: intercostal nerves block in the midaxillary line;Drug: dexketoprofen<br> <br> Drug: paracetamol<br> <br> |
| Active Comparator: paravertebral block&dexketoprofen&paracetamol<br>dexketoprofen: 50 mg/8h paracetamol: 1g/6h | Procedure: paravertebral block<br> <br> Drug: dexketoprofen<br> <br> Drug: paracetamol<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 24 h |