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

Phase 4

• Conditions: no Reconstructive Breast Surgery
• Interventions: Procedure: BRILMA; Procedure: paravertebral block; Drug: dexketoprofen; Drug: paracetamol

• Registration Number: NCT02018601
• Lead Sponsor: Paula Diéguez García

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-12-10
• Study First Submitted QC: 2013-12-17
• Study First Posted: 2013-12-23
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-30
• Last Update Posted: 2019-07-31
• Primary Completion: 2021-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
paravertebral block&dexketoprofen&paracetamol	dexketoprofen	dexketoprofen: 50 mg/8h paracetamol: 1g/6h
BRILMA&dexketoprofen&paracetamol	BRILMA	dexketoprofen: 50 mg/8h paracetamol: 1gr/6h
paravertebral block&dexketoprofen&paracetamol	paravertebral block	dexketoprofen: 50 mg/8h paracetamol: 1g/6h
BRILMA&dexketoprofen&paracetamol	dexketoprofen	dexketoprofen: 50 mg/8h paracetamol: 1gr/6h
BRILMA&dexketoprofen&paracetamol	paracetamol	dexketoprofen: 50 mg/8h paracetamol: 1gr/6h
paravertebral block&dexketoprofen&paracetamol	paracetamol	dexketoprofen: 50 mg/8h paracetamol: 1g/6h

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Abente y Lago. Complejo Hospitalario Universitario A Coruña; 🇪🇸 A Coruña, Spain