Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
55 participants
INTERVENTIONAL
2015-12-31
2017-02-28
Brief Summary
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102 patients undergoing reconstruction breast surgery will be randomized into two groups: Group PVB (n=51) will receive US guided paravertebral thoracic block (between T2-T6) performed with 30ml of 0.25% levobupivacaine before general anesthesia (TCI-TIVA) induction.
Morphine patient control analgesia (PCA) with loading dose i.v. titrated by the PACU nurse if pain \> 5/10 at rest Group PECS (n=51) will receive US guided pectorals nerves block performed with 30ml of 0.25% levobupivacaine before general anesthesia (TCI-TIVA) induction.
Morphine PCA with loading dose i.v. titrated by the post-anesthesia care unit (PACU) nurse if pain \> 5/10 at rest
Primary Outcome Measures:
Morphine consumption (mg) (Time Frame: 24 hours) in two Groups
Secondary Outcome Measures:
Pain at rest and during movement quantified as Numerical Rating Scores (0-10) during the first 24 hours postoperatively.
Eventual side effects such as nausea/vomiting. Time necessary to perform the procedure. Pain during procedure execution quantified as Numerical Rating Scores (0-10) Hypnotic and opioids intraoperative consumption to ensure general anesthesia with Bispectral Index between 40 and 60.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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PVB
51 patients receiving US guided homolateral paravertebral thoracic block with 30ml of 0.25% levobupivacaine, before general anesthesia (TCI-TIVA).
Paravertebral Thoracic block
Levobupivacaine 0.25%
Morphine
PECS
51 patients receiving US guided pectorals nerve block with 30ml of 0.25% levobupivacaine, before general anesthesia (TCI-TIVA).
Pectorals nerve block
Levobupivacaine 0.25%
Morphine
Interventions
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Paravertebral Thoracic block
Pectorals nerve block
Levobupivacaine 0.25%
Morphine
Eligibility Criteria
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Inclusion Criteria
* ASA score I - II - III
* undergoing elective reconstruction breast surgery
* signed informed consent
Exclusion Criteria
* urgent/emergent surgery
* postoperative transfer to the intensive care unit
* known allergy to any drug medication
* local skin infection
* epilepsy
* alcohol or drug abuse
18 Years
FEMALE
No
Sponsors
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Istituti Ospitalieri di Cremona
OTHER
Responsible Party
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Giorgio Danelli
Chief of the Anaesthesia Department, Istituti Ospitalieri, Cremon
Principal Investigators
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Giorgio F Danelli, MD
Role: STUDY_DIRECTOR
Istituti Ospedalieri di Cremona
Locations
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Azienda Ospedaliera Istituti Ospitalieri di Cremona
Cremona, CR, Italy
Countries
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Other Identifiers
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20995/2014ps
Identifier Type: -
Identifier Source: org_study_id
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