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

Breast Cancer Clinical Trial

Official title:

The Combination of PECS II Block and Parasternal Block Provide Useful Analgesia After Radical Mastectomy With Axillary Dissection and Implant Breast Reconstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03754816
• Other study ID #: 0180910/16
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: April 12, 2019

Study information

• Verified date: April 2019
• Source: San Salvatore Hospital of L'Aquila
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

The cambionation of PECS II block and parasternal block

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: April 12, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• ASA status patients:1,2 and 3

• patients undergoing to radical mastectomy with axillary dissection and breast-implant reconstruction

Exclusion Criteria:

• patients with allergy to local anesthetics

• ASA status patients: 4

• breast anatomy abnormalities

• neurological diseases

• septic conditions

• coagulopathies

• drug abuse history

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Procedure:
• PECS II and parasternal block
10 ml of Levobupivacaine 0.375% injected between minor and major pectoralis muscles. 20 ml of Levobupivacaine 0.375% injected between minor and serratus muscles. 10 ml of Levobupivacaine 0.375% injected between major and intercostal muscles at II and IV intercostal space.

Drug:
• Levobupivacaine
Levobupivacaine

Locations

Country	Name	City	State
Italy	San Salvatore Academic Hospital	Coppito	L'Aquila

Sponsors (1)

Lead Sponsor	Collaborator
San Salvatore Hospital of L'Aquila

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain: Numeric Rate Scale	Postoperative pain evaluated with Numeric Rate Scale, from 0 (no pain) to 10 (worst pain)	24 hours after surgery
Secondary	Intraoperative opiates	Number of patients needing of equianalgesic mg of intraoperative morphine	From start to the end of surgery
Secondary	Postoperative opiates	Number of patients needing of equianalgesic mg of postoperative morphine	24 hours after surgery
Secondary	Side effects	Number of patients with postoperative nausea and vomiting	24 hours after surgery