NCT01611324|CompletedPhase 4DMC
Painless Local Infiltration Anesthesia
EASE
Efficacy of Alkalinised 2% Mepivacaine for Local Infiltration Anesthesia, in Ambulatory Phlebectomy
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Sponsor study identifier
interventional
100
1 country
1
Study Start
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2012
Actual (reported)Study Completion
December 2012
Actual (reported)The purpose of this study is to assess if a dilution with 1.4% sodium bicarbonate of a 2% mepivacaine+epinephrine solution, can be effective in reducing the pain associated with local infiltration anesthesia, during ambulatory phlebectomy procedures.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
May 17, 2012
Actual (reported)June 4, 2012
Actual (reported)December 2012
Actual (reported)December 2012
Actual (reported)Pain Assessment
Pain severity will be rated by the subjects on a visual analog scale, after the first five injections (placement of the needle + administration of anesthetic solution).
Initial 2 minutes of the procedure
4 mL mepivacaine chlorhydrate 20 mg/mL with epinephrine 5 mcg/mL diluted with 16 mL sodium bicarbonate 1.4%
4 mL mepivacaine chlorhydrate 20 mg/mL with epinephrine 5 mcg/mL diluted with 16 mL sodium chloride 0.9%
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Mepivacaine chlorhydrate 2% with epinephrine in NS 0.9%
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordPoliclinico Universitario Campus Bio-Medico
Rome, RM, 00128, Italy
Creton D, Rea B, Pittaluga P, Chastanet S, Allaert FA. Evaluation of the pain in varicose vein surgery under tumescent local anaesthesia using sodium bicarbonate as excipient without any intravenous sedation. Phlebology. 2012 Oct;27(7):368-73. doi: 10.1258/phleb.2011.011026. Epub 2011 Nov 21.
Stefano Ricci, M.D.
University Campus Bio-Medico
Leo Moro, M.D.
University Campus Bio-Medico
Francesco Maria Serino, M.D.
University Campus Bio-Medico
Raffaele Antonelli Incalzi, M.D.
University Campus Bio-Medico
100 participants (actual enrollment reported by the registry).
First Submitted
May 17, 2012
First Posted
June 4, 2012
Study Start
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
Comparison of Preincisional Infiltrated Dexmedetomidine and Lidocaine Plus Adrenaline for Nasal Sephoplasty Surgery.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
December 2012
Actual (reported)Study Completion
December 2012
Actual (reported)Last Updated
December 11, 2012
Record last verified: 2012-12
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Source: ClinicalTrials.gov.
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