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

no Reconstructive Breast Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02018601
• Other study ID #: ProsMaMa 13.1
• Status: Recruiting
• Phase: Phase 4
• Start date: September 2013
• Est. completion date: December 2022

Study information

• Verified date: July 2019
• Source: Complexo Hospitalario Universitario de A Coruña
• Contact: Paula Diéguez, Anesthesiologist
• Email: pauladieguez[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• no Reconstructive Breast Surgery

Intervention

Procedure:
• BRILMA

• paravertebral block

Drug:
• dexketoprofen

• paracetamol

Locations

Country	Name	City	State
Spain	Hospital Abente y Lago. Complejo Hospitalario Universitario A Coruña	A Coruña

Sponsors (1)

Lead Sponsor	Collaborator
Paula Diéguez García

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain score: verbal simple scale	admission to post-anesthesia care unit (PACU)	0,3,6,12,18 and 24h
Primary	pain score: visual number scale	post-admission to PACU	0, 3, 6,12, 18, 24h
Primary	opioid requirements	0 dose/ 1 dose/ 2 or more doses	24 h
Primary	sleep quality	bad/regular/good	24 h
Primary	amount of sleep	< 3h/ 3-6h, >6h	24 h
Secondary	percentage of participants with nausea and vomiting	without symptoms/ nausea/vomiting/ both symptoms	24 hours
Secondary	Number of Participants with Serious and Non-Serious Adverse Events	directly due to block nerve and general complications	24 h