The Combination of PECS II Block and Parasternal Block for Radical Mastectomy

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: PECS II and parasternal block; Drug: Levobupivacaine

• Registration Number: NCT03754816
• Lead Sponsor: San Salvatore Hospital of L'Aquila

Brief Summary

The combination of PECS II and parasternal Block provides analgesia after radical mastectomy

Detailed Description

The cambionation of PECS II block and parasternal block

Study Timeline

• Study First Submitted: 2018-11-25
• Study First Submitted QC: 2018-11-26
• Study First Posted: 2018-11-27
• Study Start: 2018-12-01
• Primary Completion: 2019-03-31
• Status Verified: 2019-04
• Study Completion: 2019-04-12
• Last Update Submitted: 2019-04-17
• Last Update Posted: 2019-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 65

Inclusion Criteria

• ASA status patients:1,2 and 3
• patients undergoing to radical mastectomy with axillary dissection and breast-implant reconstruction

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Exclusion Criteria

• patients with allergy to local anesthetics
• ASA status patients: 4
• breast anatomy abnormalities
• neurological diseases
• septic conditions
• coagulopathies
• drug abuse history

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental group	PECS II and parasternal block	The combination of PECS II and parasternal block performed by injecting Levobupivacaine 0.375% 40 ml, injected between minor and major pectoralis muscles, between minor and serratus muscles and between major and intercostal muscles
Experimental group	Levobupivacaine	The combination of PECS II and parasternal block performed by injecting Levobupivacaine 0.375% 40 ml, injected between minor and major pectoralis muscles, between minor and serratus muscles and between major and intercostal muscles

Primary Outcome Measures

Name	Time	Method
Postoperative pain: Numeric Rate Scale	24 hours after surgery	Postoperative pain evaluated with Numeric Rate Scale, from 0 (no pain) to 10 (worst pain)

Secondary Outcome Measures

Name	Time	Method
Intraoperative opiates	From start to the end of surgery	Number of patients needing of equianalgesic mg of intraoperative morphine
Side effects	24 hours after surgery	Number of patients with postoperative nausea and vomiting
Postoperative opiates	24 hours after surgery	Number of patients needing of equianalgesic mg of postoperative morphine

Trial Locations

Locations (1)

San Salvatore Academic Hospital; 🇮🇹 Coppito, L'Aquila, Italy