Intercostal Nerves Block in the Midaxillary Line Versus Paravertebral Block, Ultrasound Guided Blocks for no Reconstructive Breast Surgery. Randomized Trial
Overview
- Phase
- Phase 4
- Intervention
- BRILMA
- Conditions
- no Reconstructive Breast Surgery
- Sponsor
- Paula Diéguez García
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- pain score: visual number scale
- Last Updated
- 6 years ago
Overview
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.
Investigators
Paula Diéguez García
anesthesiologist
Complexo Hospitalario Universitario de A Coruña
Eligibility Criteria
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
- •Chronic treatment with non-steroidal anti-inflammatory drugs, antidepressants, anticonvulsants or opioids.
Arms & Interventions
BRILMA&dexketoprofen¶cetamol
dexketoprofen: 50 mg/8h paracetamol: 1gr/6h
Intervention: BRILMA
BRILMA&dexketoprofen¶cetamol
dexketoprofen: 50 mg/8h paracetamol: 1gr/6h
Intervention: dexketoprofen
BRILMA&dexketoprofen¶cetamol
dexketoprofen: 50 mg/8h paracetamol: 1gr/6h
Intervention: paracetamol
paravertebral block&dexketoprofen¶cetamol
dexketoprofen: 50 mg/8h paracetamol: 1g/6h
Intervention: paravertebral block
paravertebral block&dexketoprofen¶cetamol
dexketoprofen: 50 mg/8h paracetamol: 1g/6h
Intervention: dexketoprofen
paravertebral block&dexketoprofen¶cetamol
dexketoprofen: 50 mg/8h paracetamol: 1g/6h
Intervention: paracetamol
Outcomes
Primary Outcomes
pain score: visual number scale
Time Frame: 0, 3, 6,12, 18, 24h
post-admission to PACU
pain score: verbal simple scale
Time Frame: 0,3,6,12,18 and 24h
admission to post-anesthesia care unit (PACU)
opioid requirements
Time Frame: 24 h
0 dose/ 1 dose/ 2 or more doses
sleep quality
Time Frame: 24 h
bad/regular/good
amount of sleep
Time Frame: 24 h
\< 3h/ 3-6h, \>6h
Secondary Outcomes
- Number of Participants with Serious and Non-Serious Adverse Events(24 h)
- percentage of participants with nausea and vomiting(24 hours)