no Reconstructive Breast Surgery
Conditions
Brief summary
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.
Interventions
PROCEDUREBRILMA
PROCEDUREparavertebral block
DRUGdexketoprofen
DRUGparacetamol
Sponsors
Paula Diéguez García
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients scheduled for not reconstructive unilateral breast surgery. 2. Physical status American Society Anesthesiologists (ASA) I-III. 3. Signed informed consent. 4. Aged between 18 and 75 years. 5. Ability to assess pain using a verbal and numerical scales. 6. Assessment of pain at the time of inclusion in the study is lower than 3 verbal simple scale
Exclusion criteria
1. Personal history of disorders of hemostasis or previous history of abnormal bleeding evidence. 2. Local infection at the site of the puncture or to puncture prior systemic. 3. Contraindications to study medication. 4. Muscle or neurological disease, peripheral or central. 5. Patients with prior history of opioid. 6. Pregnancy or lactation. 7. Difficulties in assessing pain or inability to understand or assist in the development of the study (psychiatric illness, cognitive impairments) 8. Active Chronic alcoholism or drug addiction. 9. BMI under 20 or mayor 30. 10. Chronic treatment with non-steroidal anti-inflammatory drugs, antidepressants, anticonvulsants or opioids. 11. Rejection of the patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pain score: visual number scale | 0, 3, 6,12, 18, 24h | post-admission to PACU |
| sleep quality | 24 h | bad/regular/good |
| amount of sleep | 24 h | \< 3h/ 3-6h, \>6h |
| pain score: verbal simple scale | 0,3,6,12,18 and 24h | admission to post-anesthesia care unit (PACU) |
| opioid requirements | 24 h | 0 dose/ 1 dose/ 2 or more doses |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Serious and Non-Serious Adverse Events | 24 h | directly due to block nerve and general complications |
| percentage of participants with nausea and vomiting | 24 hours | without symptoms/ nausea/vomiting/ both symptoms |
Countries
Spain
Contacts
Primary ContactPaula Diéguez, Anesthesiologist
Outcome results
None listed