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

July 30, 2019 updated by: Paula Diéguez García

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • A Coruña, Spain, 15006
        • Recruiting
        • Hospital Abente y Lago. Complejo Hospitalario Universitario A Coruña
        • Contact:
        • Principal Investigator:
          • Paula Diéguez, Anesthesiologist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BRILMA&dexketoprofen¶cetamol
dexketoprofen: 50 mg/8h paracetamol: 1gr/6h
Drug: paracetamol
Procedure: BRILMA
Other Names:
  • intercostal nerves block in the midaxillary line
Drug: dexketoprofen
Active Comparator: paravertebral block&dexketoprofen¶cetamol
dexketoprofen: 50 mg/8h paracetamol: 1g/6h
Drug: paracetamol
Drug: dexketoprofen
Procedure: paravertebral block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain score: verbal simple scale
Time Frame: 0,3,6,12,18 and 24h
admission to post-anesthesia care unit (PACU)
0,3,6,12,18 and 24h
pain score: visual number scale
Time Frame: 0, 3, 6,12, 18, 24h
post-admission to PACU
0, 3, 6,12, 18, 24h
opioid requirements
Time Frame: 24 h
0 dose/ 1 dose/ 2 or more doses
24 h
sleep quality
Time Frame: 24 h
bad/regular/good
24 h
amount of sleep
Time Frame: 24 h
< 3h/ 3-6h, >6h
24 h

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percentage of participants with nausea and vomiting
Time Frame: 24 hours
without symptoms/ nausea/vomiting/ both symptoms
24 hours
Number of Participants with Serious and Non-Serious Adverse Events
Time Frame: 24 h
directly due to block nerve and general complications
24 h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paula Diéguez García

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

December 10, 2013

First Submitted That Met QC Criteria

December 17, 2013

First Posted (Estimate)

December 23, 2013

Study Record Updates

Last Update Posted (Actual)

July 31, 2019

Last Update Submitted That Met QC Criteria

July 30, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ProsMaMa 13.1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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