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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02018601
Recruitment Status : Recruiting
First Posted : December 23, 2013
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Paula Diéguez García, Complexo Hospitalario Universitario de A Coruña

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.

Condition or disease Intervention/treatment Phase
no Reconstructive Breast Surgery Procedure: BRILMA Procedure: paravertebral block Drug: dexketoprofen Drug: paracetamol Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Intercostal Nerves Block in the Midaxillary Line Versus Paravertebral Block, Ultrasound Guided Blocks for no Reconstructive Breast Surgery. Randomized Trial
Study Start Date : September 2013
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Experimental: BRILMA&dexketoprofen&paracetamol
dexketoprofen: 50 mg/8h paracetamol: 1gr/6h
Procedure: BRILMA
Other Name: intercostal nerves block in the midaxillary line

Drug: dexketoprofen
Drug: paracetamol
Active Comparator: paravertebral block&dexketoprofen&paracetamol
dexketoprofen: 50 mg/8h paracetamol: 1g/6h
Procedure: paravertebral block
Drug: dexketoprofen
Drug: paracetamol



Primary Outcome Measures :
  1. pain score: verbal simple scale [ Time Frame: 0,3,6,12,18 and 24h ]
    admission to post-anesthesia care unit (PACU)

  2. pain score: visual number scale [ Time Frame: 0, 3, 6,12, 18, 24h ]
    post-admission to PACU

  3. opioid requirements [ Time Frame: 24 h ]
    0 dose/ 1 dose/ 2 or more doses

  4. sleep quality [ Time Frame: 24 h ]
    bad/regular/good

  5. amount of sleep [ Time Frame: 24 h ]
    < 3h/ 3-6h, >6h


Secondary Outcome Measures :
  1. percentage of participants with nausea and vomiting [ Time Frame: 24 hours ]
    without symptoms/ nausea/vomiting/ both symptoms

  2. Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: 24 h ]
    directly due to block nerve and general complications



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02018601


Contacts
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Contact: Paula Diéguez, Anesthesiologist pauladieguez@yahoo.com

Locations
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Spain
Hospital Abente y Lago. Complejo Hospitalario Universitario A Coruña Recruiting
A Coruña, Spain, 15006
Contact: Paula Diéguez, Anesthesiologist       pauladieguez@yahoo.com   
Principal Investigator: Paula Diéguez, Anesthesiologist         
Sponsors and Collaborators
Paula Diéguez García

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Responsible Party: Paula Diéguez García, anesthesiologist, Complexo Hospitalario Universitario de A Coruña
ClinicalTrials.gov Identifier: NCT02018601    
Other Study ID Numbers: ProsMaMa 13.1
First Posted: December 23, 2013    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Acetaminophen
Dexketoprofen trometamol
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents