Anesthetic Efficacy of PECS II Block and Parasternal Block

Anesthesia, Local Clinical Trial

Official title:

Anesthetic Efficacy of PECS II Block and Parasternal Block for Quadrantectomy With or Without Axillary Dissection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03016117
• Other study ID #: SanSalvatoreH
• Status: Completed
• Phase: N/A
• Start date: March 15, 2017
• Est. completion date: November 29, 2018

Study information

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

Clinical Trial Summary

The study evaluate the anesthetic efficacy of Pecs II block II and parasternal block during quadrantectomy with or without axillary dissection, in breast cancer surgery

Description:

All patients receive Pecs II block and parasternal block, under ultrasound guidance. Pecs II block, performed at the 4th rib level, and parasternal block performed at the level of the 2nd and 4th intercostal space level. Data on the anesthesia, side effects and pain, will be recorded

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: November 29, 2018
• Est. primary completion date: October 25, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• patients who need of quadrantectomy with or without axillary dissection

• ASA I-III patients

• age between 18 and 75 years

• filled informed consent

Exclusion Criteria:

• pregnant women

• obesity (BMI > 39,99)

• radical mastectomy

• ASA IV patients

• chest wall abnormalities

• neurological disorders

• septic status

• chest skin infections

• coagulopathies

Related Conditions & MeSH terms

• Anesthesia, Local

Intervention

Procedure:
• Pecs II block and parasternal block
The Pecs II block will be performed under ultrasound guidance, at fourth rib level, on the axillary line, into the fascial plane between pectoralis minor muscle and serratus muscle. The parasternal block will be performed under ultrasound guidance, at the second and fourth intercostal space, between the pectoralis major muscle and the intercostal muscles, near to the external intercostal membrane.

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	Anesthetic efficacy	The anesthetic efficacy is tested by cold and touch test	The anesthetic efficacy was assessed in the first 72 hours, after block
Secondary	Painkillers request	mg of morphine	The painkillers request was assessed in the first 72 hours, after surgery
Secondary	Side effects	Nausea, vomiting, local anesthetic systemic toxicity	The side effects recorded in the first 72 hours, after surgery