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Completed

NCT Number: NCT03754816

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

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

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Key information

Conditions

Breast Cancer Agnosia Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

San Salvatore Academic Hospital

Coppito, L'Aquila, 67100, Italy

About this study

The cambionation of PECS II block and parasternal block

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PECS II and parasternal block

Procedure

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.

Other names: Pectoral nerve block II type and parasternal block

Levobupivacaine

Drug

Levobupivacaine

Other names: Locali anesthetic

Primary outcomes

  1. Postoperative pain: Numeric Rate Scale

    Time frame: 24 hours after surgery

    Postoperative pain evaluated with Numeric Rate Scale, from 0 (no pain) to 10 (worst pain)

Secondary outcomes

  1. Intraoperative opiates

    Time frame: From start to the end of surgery

    Number of patients needing of equianalgesic mg of intraoperative morphine

  2. Postoperative opiates

    Time frame: 24 hours after surgery

    Number of patients needing of equianalgesic mg of postoperative morphine

  3. Side effects

    Time frame: 24 hours after surgery

    Number of patients with postoperative nausea and vomiting

Sponsors and collaborators

Lead sponsor

San Salvatore Hospital of L'Aquila

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 27, 2018
Registry last updated
Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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