IT Pacira Exparel (Healthy Volunteers) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn more about the safety and effectiveness of the study drug, Exparel (which is a liposome, or surrounded in fat molecules) when it is injected with Bupivacaine. Bupivacaine acts by numbing the area around where it is given to help decrease pain.

What is the Condition Being Studied?

Healthy Participants

Who Can Participate in the Study?

-Healthy Adults, 18-50
-No kidney problems
-No blood thinning problems

Age Group
Adults

What is Involved?

If you choose to join this study you will:
-Be randomized (like drawing numbers out of a hat) to 1 of 3 groups
--Group 1 will get the study drug (Exparel) injected into their spinal region
--Group 2 will get Bupivacaine injected into their spinal region
--Group 3 will get a placebo (harmless saltwater) injected into their spinal region
-Agree to be admitted to the unit for monitoring and tests for 5 nights
-Complete a follow-up visit at the clinic on day 9
-Complete a follow-up phone call on day 30

Study Details

Full Title
Phase 1, Randomized, Double-Blind, Active and Placebo Controlled, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Bupivacaine Liposome Injectable Suspension Administered via a Single Intrathecal Injection to Healthy Volunteers
Principal Investigator
Protocol Number
IRB: PRO00103806
NCT: NCT04173611
Phase
Phase I
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698