Ulnar nerve block induced by the new local anesthetic IQB-9302 in healthy volunteers: a comparison with bupivacaine.
We evaluated the duration of sensory anesthesia after blockade of the ulnar nerve of IQB-9302, a new local amide anesthetic, compared with bupivacaine. A double-blinded, randomized, cross-over study in 12 healthy volunteers aged 18 to 35 yr was performed. Three milliliters of 0.25% IQB-9302 was administered in one wrist and bupivacaine in the other. A week later, the blocks were repeated with a concentration of 0.5%. These concentrations were chosen because they seemed to be equipotent in previous studies. The duration of sensory anesthesia was the main variable measured; secondary outcomes were motor block, time to onset, and time to recovery from block. The duration of sensory block was similar for IQB-9302 and bupivacaine at a concentration of 0.25%; median and range: 409 min (0-800 min) for IQB-9302 and 258 min (0-665 min) for bupivacaine (95% confidence interval for the difference from -47 to 545, P = 0.82, Wilcoxon's test). The results with 0.5% were: 525 min (440-735 min) and 690 min (365-1098 min), respectively (P = 0.026). There were no significant differences in the other variables measured. No important adverse reactions were seen. We conclude that IQB-9302 is an effective new local anesthetic for blockade of ulnar nerve at the concentrations tested.


CONCLUSIONS
IQB-9302 is a new local anesthetic that has shown a long duration of action and low cardiovascular toxicity in preclinical studies. We report the results of a phase I clinical trial to compare this new drug with bupivacaine for ulnar nerve block.
Gálvez-Múgica
M A
MA
Servicio de Farmacología Clínica, Hospital Universitario de La Princesa, Madrid, Spain.
Santos-Ampuero
M A
MA
Novalbos
J
J
Gallego Sandín
S
S
Galiano
A
A
Gilsanz
F
F
García
A G
AG
Abad-Santos
F
F
D000293:Adolescent; D000328:Adult; D000779:Anesthetics, Local / Q000009:adverse effects; D002045:Bupivacaine / Q000009:adverse effects; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D009407:Nerve Block / Q000379:methods*; D010880:Piperidines / Q000009:adverse effects; D012881:Skin Temperature / Q000187:drug effects; D014459:Ulnar Nerve / Q000187:drug effects*
D000779:Anesthetics, Local; C418003:IQB 9302; D010880:Piperidines; D002045:Bupivacaine