Abstract | BACKGROUND/OBJECTIVE: MATERIALS AND METHODS: In this Phase 1, single-blind, crossover study, healthy volunteers (n = 132) were randomized to four sequential cohorts to receive subcutaneous normal saline in one arm and either liposome bupivacaine 40 mg or bupivacaine HCl 7.5 mg in the other. At 30, 15, 5, and 2 minutes after study drug administration for Cohorts 1 - 4 respectively, an incision was made in each arm and 18% acetic acid solution was applied to elicit pain. The primary outcome measure was a subject's assessment of pain intensity on a 100 mm visual analog scale. RESULTS: CONCLUSIONS:
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Authors | Glen Apseloff, Erol Onel, Gary Patou |
Journal | International journal of clinical pharmacology and therapeutics
(Int J Clin Pharmacol Ther)
Vol. 51
Issue 5
Pg. 367-73
(May 2013)
ISSN: 0946-1965 [Print] Germany |
PMID | 23458225
(Publication Type: Clinical Trial, Phase I, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anesthetics, Local
- Delayed-Action Preparations
- Liposomes
- Bupivacaine
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Topics |
- Adult
- Anesthetics, Local
(administration & dosage, adverse effects)
- Bupivacaine
(administration & dosage, adverse effects)
- Chemistry, Pharmaceutical
- Cross-Over Studies
- Delayed-Action Preparations
- Female
- Humans
- Injections, Intradermal
- Liposomes
- Male
- Middle Aged
- Ohio
- Pain
(diagnosis, physiopathology, prevention & control)
- Pain Measurement
- Pain Threshold
(drug effects)
- Single-Blind Method
- Time Factors
- Young Adult
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