Intercostal Nerves Block in the Midaxillary Line Versus Paravertebral Block for no Reconstructive Breast Surgery
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2013
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 10, 2013
CompletedFirst Posted
Study publicly available on registry
December 23, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedJuly 31, 2019
July 1, 2019
8.3 years
December 10, 2013
July 30, 2019
Conditions
Outcome Measures
Primary Outcomes (5)
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 Outcomes (2)
percentage of participants with nausea and vomiting
24 hours
Number of Participants with Serious and Non-Serious Adverse Events
24 h
Study Arms (2)
BRILMA&dexketoprofen¶cetamol
EXPERIMENTALdexketoprofen: 50 mg/8h paracetamol: 1gr/6h
paravertebral block&dexketoprofen¶cetamol
ACTIVE COMPARATORdexketoprofen: 50 mg/8h paracetamol: 1g/6h
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Abente y Lago. Complejo Hospitalario Universitario A Coruña
A Coruña, 15006, Spain
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- anesthesiologist
Study Record Dates
First Submitted
December 10, 2013
First Posted
December 23, 2013
Study Start
September 1, 2013
Primary Completion
December 1, 2021
Study Completion
December 1, 2022
Last Updated
July 31, 2019
Record last verified: 2019-07