105
Participants
Start Date
May 31, 2013
Primary Completion Date
March 31, 2014
Study Completion Date
April 30, 2014
Neosaxitoxin in saline
NeoSTX will be administered in sequential dose cohorts. Each subject receives one injection with bupivacaine 0.2% alone on one side (control). On the other side they receive NeoSTX in saline (test). Subjects receive NeoSTX in saline in subsequent dose escalation levels: 5 mcg, 10 mcg, 15 mcg, 20 mcg, 30 mcg, and 40 mcg of NeoSTX.
NeoSTX + bupivacaine 0.2%
NeoSTX will be administered in sequential dose cohorts. Each subject receives one injection with bupivacaine 0.2% on one side (control). On the other side they receive NeoSTX with 0.2% bupivacaine. Subjects receive NeoSTX in 0.2% bupivacaine in subsequent dose escalation levels: 5 mcg, 10 mcg, 15 mcg, 20 mcg, 30 mcg, and 40 mcg of NeoSTX.
NeoSTX + bupivacaine 0.2% + epinephrine 5mcg/ml
Each subject receives one injection with bupivacaine 0.2% on one side (control). On the other side they receive NeoSTX in 0.2% bupivacaine with epinephrine 5 mcg/ml. Subjects receive NeoSTX in 0.2% bupivacaine with epinephrine 5 mcg/ml in doses of 10 mcg or 30 mcg of NeoSTX.
Saline placebo
Each subject receives one injection with bupivacaine 0.2% alone on one side. On the other side they receive saline placebo.
Boston Children's Hospital, Boston
Charles Berde
OTHER