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Completed

NCT Number: NCT01818817

Ultrasound Paravertebral Block in Breast Surgery.

The purpouse of the study is to determine wether Ultrasound Guided,Ens-assisted paravertebral block with single shot is a safe and reliable anesthetic technique in breast surgery.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–90 year

Sex eligibility

Female

Study type

Observational

Primary location

Campus Bio Medico

Rome, RM, 00128, Italy

About this study

General anaesthesia is currently the conventional technique used for breast surgery. Thoracic Paravertebral block (PVB) has been used with multiple injection.

We compared a single injection thoracic PVB with general anaesthesia (GA) in 20 consenting patients, scheduled for unilateral breast surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American Society of Anesthesiologists classification I-III
  • Written informed consent
  • Age older than 18 years old

Exclusion criteria

  • allergy to local anesthetics
  • local sepsis

Treatment and study plan

Primary outcomes

  1. Post-operative pain

    Time frame: Up to 24 hours

    The anesthesist evaluated the post-operative pain at rest and in movement with the NRS at 3-6-12-24 hours.

Secondary outcomes

  1. Consumption of analgesic drugs

    Time frame: up to 24 hours

    We register the consumption of analgesic drugs in both groups in the post-operative period till 24 hours.

  2. Efficacy of Paravertebral block

    Time frame: pre-operative

    We evaluate efficacy and extension of the block with ice test and pin-prick test

Other outcomes

  1. Post-operative nausea and vomit

    Time frame: up to 24 hours

    We register the incidence of nausea and vomit in the post-perative time.

  2. Appreciation of patients

    Time frame: At 24 hours

    We administer an assessment questionnaire to patients to evaluate the appreciation of the anesthesiologic technique

Sponsors and collaborators

Lead sponsor

Campus Bio-Medico University

Other

Registry information

Official study title

Single Injection, Ultrasound Guided Paravertebral Block for Anesthesia in Breast Surgery.

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 27, 2013
Registry last updated
Mar 27, 2013

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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