NCT02677571|Completed
PVB vs PECS Block in Breast Surgery
PVBvsPECS
Thoracic Paravertebral Block Versus Pectoral Nerves Block (Modified PECS) Block in Breast Surgery
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PVBvsPECS
Thoracic Paravertebral Block Versus Pectoral Nerves Block (Modified PECS) Block in Breast Surgery
Sponsor study identifier
interventional
55
1 country
1
Study Start
December 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2017
Actual (reported)Study Completion
February 2017
Actual (reported)Purpose to compare paravertebral thoracic block (PVB) and pectorals nerves block as analgesic option for major breast surgery. 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2017
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2015
Date type not reportedThis date has not been verified as actual or estimated.
January 23, 2016
Actual (reported)February 9, 2016
Actual (reported)January 2017
Actual (reported)February 2017
Actual (reported)PCA morphine consumption in the two groups within the first 24 postoperative hours
24 hours postoperatively
Numerical Rating Scores for pain at rest and during movement
24 hours postoperatively
Postoperative nausea/vomiting incidence
24 hours postoperatively
Time of performance
During procedure execution
Propofol consumption in intraoperative period
Intraoperative period
Opioids (remifentanyl) consumption in intraoperative period
Intraoperative period
51 patients receiving US guided homolateral paravertebral thoracic block with 30ml of 0.25% levobupivacaine, before general anesthesia (TCI-TIVA).
51 patients receiving US guided pectorals nerve block with 30ml of 0.25% levobupivacaine, before general anesthesia (TCI-TIVA).
Azienda Ospedaliera Istituti Ospitalieri di Cremona
Cremona, CR, 26100, Italy
Giorgio F Danelli, MD
Istituti Ospedalieri di Cremona
55 participants (actual enrollment reported by the registry).
First Submitted
January 23, 2016
First Posted
February 9, 2016
Study Start
December 2015
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
January 2017
Actual (reported)Study Completion
February 2017
Actual (reported)Last Updated
February 3, 2017
Record last verified: 2017-02
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Source: ClinicalTrials.gov.
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