Purpose of this Study
We are doing this study to find out if giving a drug called Exparel (the study drug) as a spinal injection is a safe and effective option for pain management. The study drug is approved to treat pain after surgery and is injected into the surrounding area where the surgery was done. We want to know if the study drug can also be given as an intrathecal (into the space surrounding the spine) injection to help control pain.
Who Can Participate?
Eligibility
Adults ages 18-50 who:
- Are in general good health
- Have the time to check into our clinic for 6 days and 5 nights
- Have no medical conditions related to their kidneys, liver, or cardiovascular system
- Have no history of frequently occurring headaches (migraines, cluster headache or tension headache)
- Have no other pain-related conditions that require medication
For more information about who can join this study, contact the study team at 919-681-2849.
- Are in general good health
- Have the time to check into our clinic for 6 days and 5 nights
- Have no medical conditions related to their kidneys, liver, or cardiovascular system
- Have no history of frequently occurring headaches (migraines, cluster headache or tension headache)
- Have no other pain-related conditions that require medication
For more information about who can join this study, contact the study team at 919-681-2849.
Age Range
18-50
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
Yes
What is Involved?
If you choose to join this study, you will:
- Get a single spinal injection of the study drug
- Have 4 lumbar punctures (spinal tap) to collect spinal fluid (CSF)
- Check in to our clinic at Duke Hospital for a stay that lasts 6 days and 5 nights
- Fill out questionnaires
- Have sensory and motor assessments done
- Have blood draws and give urine samples
We will pay study participants for their time.
To learn more about this study or let us know that you are interested, please visit our website:
https://redcap.duke.edu/redcap/surveys/?s=XAAKKE8YJ98X7XYL
- Get a single spinal injection of the study drug
- Have 4 lumbar punctures (spinal tap) to collect spinal fluid (CSF)
- Check in to our clinic at Duke Hospital for a stay that lasts 6 days and 5 nights
- Fill out questionnaires
- Have sensory and motor assessments done
- Have blood draws and give urine samples
We will pay study participants for their time.
To learn more about this study or let us know that you are interested, please visit our website:
https://redcap.duke.edu/redcap/surveys/?s=XAAKKE8YJ98X7XYL
Locations
Duke University Hospital
Other
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Phase 1, Double-Blind, Active- and Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Liposomal Bupivacaine 13.3 Administered via a Single Intrathecal Injection to Healthy Volunteers
Study Website
Principal Investigator
David
MacLeod
Protocol Number
PRO00112280
NCT ID
NCT05456490
Phase
I
Enrollment Status
OPEN TO ACCRUAL