Safety Study of Long-Acting Local Anesthetic

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

The primary aim of this Phase 1 study is to evaluate the systemic safety of a novel prolonged-duration local anesthetic, Neosaxitoxin (NeoSTX), given by subcutaneous injection in combination with the commonly used local anesthetic, bupivacaine, and epinephrine.

The investigators hypothesize that a "minimal adverse effect threshold" NeoSTX dose for subcutaneous administration in combination with bupivacaine 0.2% and epinephrine 5mcg/ml respectively, can be defined for awake, young adult healthy volunteer subjects. At the same time, the pharmacokinetics of NeoSTX when delivered subcutaneously will be determined.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Charles Berde
• Treatments: Anesthetics; Anesthetics, Local; Bupivacaine; Epinephrine; Epinephryl borate; Neosaxitoxin; Racepinephrine

Criteria

Inclusion Criteria:

1. Healthy adult males ages 18-35

2. ASA physical status 1 or 2

3. English or Spanish speakers

4. Must be able to come to Boston Children's Hospital for a 24-hour stay and able and willing to attend 5-10 study visits

5. Must be able to provide informed consent

6. Must be able to understand and perform all the procedures of the study including self-reporting of symptom scores

Exclusion Criteria:

1. ASA physical status 3 or greater

2. Cognitively challenged or other inability to understand the self-report measures or to give informed consent

3. Significant cardiovascular, respiratory, neuromuscular disease or other systemic illness(es)

4. No known or suspected allergies to neosaxitoxin, bupivacaine, or other local anesthetics

5. Subjects may not be on any pain controlling medications, or any medications that would alter pain tolerance

6. Subjects may not be on any medication that would alter cognition

7. Subjects may not have any acute or chronic pain conditions requiring ongoing treatment or limiting daily activities

8. No alcohol or illicit drug abuse

9. No current smokers