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Anesthetic Efficacy of PECS II Block and Parasternal Block

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ClinicalTrials.gov Identifier: NCT03016117
Recruitment Status : Completed
First Posted : January 10, 2017
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Emiliano Petrucci, San Salvatore Hospital of L'Aquila

Brief 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

Condition or disease Intervention/treatment Phase
Anesthesia, Local Procedure: Pecs II block and parasternal block Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anesthetic Efficacy of PECS II Block and Parasternal Block for Quadrantectomy With or Without Axillary Dissection
Actual Study Start Date : March 15, 2017
Actual Primary Completion Date : October 25, 2017
Actual Study Completion Date : November 29, 2018

Arm Intervention/treatment
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
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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Painkillers request [ Time Frame: The painkillers request was assessed in the first 72 hours, after surgery ]
    mg of morphine

  2. Side effects [ Time Frame: The side effects recorded in the first 72 hours, after surgery ]
    Nausea, vomiting, local anesthetic systemic toxicity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016117


Locations
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Italy
San Salvatore Academic Hospital
Coppito, L'Aquila, Italy, 67100
Sponsors and Collaborators
San Salvatore Hospital of L'Aquila
Investigators
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Principal Investigator: Pierfrancesco Fusco, MDD San Salvatore Academic Hospital
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Responsible Party: Emiliano Petrucci, MD, San Salvatore Hospital of L'Aquila
ClinicalTrials.gov Identifier: NCT03016117    
Other Study ID Numbers: SanSalvatoreH
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No