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

NCT ID: NCT02018601

Last Updated: 2019-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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no Reconstructive Breast Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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BRILMA&dexketoprofen&paracetamol

dexketoprofen: 50 mg/8h paracetamol: 1gr/6h

Group Type EXPERIMENTAL

BRILMA

Intervention Type PROCEDURE

dexketoprofen

Intervention Type DRUG

paracetamol

Intervention Type DRUG

paravertebral block&dexketoprofen&paracetamol

dexketoprofen: 50 mg/8h paracetamol: 1g/6h

Group Type ACTIVE_COMPARATOR

paravertebral block

Intervention Type PROCEDURE

dexketoprofen

Intervention Type DRUG

paracetamol

Intervention Type DRUG

Interventions

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BRILMA

Intervention Type PROCEDURE

paravertebral block

Intervention Type PROCEDURE

dexketoprofen

Intervention Type DRUG

paracetamol

Intervention Type DRUG

Other Intervention Names

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intercostal nerves block in the midaxillary line

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Paula Diéguez García

OTHER

Sponsor Role lead

Responsible Party

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Paula Diéguez García

anesthesiologist

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Hospital Abente y Lago. Complejo Hospitalario Universitario A Coruña

A Coruña, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Paula Diéguez, Anesthesiologist

Role: CONTACT

Facility Contacts

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Paula Diéguez, Anesthesiologist

Role: primary

Other Identifiers

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ProsMaMa 13.1

Identifier Type: -

Identifier Source: org_study_id

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