Anesthetic Efficacy of PECS II Block and Parasternal Block

Overview

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

Full Title of Study: “Anesthetic Efficacy of PECS II Block and Parasternal Block for Quadrantectomy With or Without Axillary Dissection”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 25, 2017

Detailed 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

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Pecs II block and parasternal block
    • Pecs II block and parasternal block performed to provide anesthesia of breast, before of quadrantectomy with or without axillary dissection. Pecs II block performed at the 4th rib level and 20 ml of 0.5% Levobupivacaine injected, and parasternal block performed at the level of the 2nd and 4th intercostal space level, and 4 ml of 0.375% Levobupivacaine injected

Clinical Trial Outcome Measures

Primary Measures

  • Anesthetic efficacy
    • Time Frame: The anesthetic efficacy was assessed in the first 72 hours, after block
    • The anesthetic efficacy is tested by cold and touch test

Secondary Measures

  • Painkillers request
    • Time Frame: The painkillers request was assessed in the first 72 hours, after surgery
    • mg of morphine
  • Side effects
    • Time Frame: The side effects recorded in the first 72 hours, after surgery
    • Nausea, vomiting, local anesthetic systemic toxicity

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • San Salvatore Hospital of L’Aquila
  • Provider of Information About this Clinical Study
    • Principal Investigator: Emiliano Petrucci, MD – San Salvatore Hospital of L’Aquila
  • Overall Official(s)
    • Pierfrancesco Fusco, MDD, Principal Investigator, San Salvatore Academic Hospital

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