Pain
Conditions
Brief summary
Serotonergic 5-HT3 receptors in the central nervous system are involved in pain processing after nerve injury. We are interested in learning if 5-HT3 receptor antagonist ondansetron might be an appropriate drug for treating pain after nerve injury (neuropathic pain), by investigating its bio-distribution in the cerebro-spinal fluid, and the genetic variability that may affect that distribution. Study procedures will include iv ondansetron administration, serial blood draws, cerebrospinal fluid (CSF) sampling, pregnancy testing, and possible ECG.
Interventions
DRUGOndansetron
A single 15-min intravenous infusion of ondansetron
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18 and 70 years old; 2. Patients planned to undergo hip or knee arthroplasty with spinal anesthesia; 3. Ability to provide informed consent
Exclusion criteria
1. Not giving consent to participate in the study; 2. Patients with history of or current hepatic or renal insufficiency; 3. Patients with BMI ≥ 33; 4. Patients with heart failure or active arrhythmias; 5. Patients with severe systemic disease that is a constant threat to life; 6. Contraindication or allergy to ondansetron; 7. Pregnancy or lactation. 8. Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CSF to Plasma Concentration Ratio | 0-180 min from the beginning of infusion | CSF: plasma ratio of ondansetron at the time of obtaining the CSF sample |
Countries
United States
Participant flow
Recruitment details
19 consented, 3 participants withdrew prior to any intervention, and 1 participant excluded before outcomes data collection
Participants by arm
| Arm | Count |
|---|---|
| Open Label Infusion Ondansetron The entire cohort of subjects in this open-label study | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Open Label Infusion Ondansetron |
|---|---|
| Age, Continuous | 58.0 years STANDARD_DEVIATION 6.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
CSF to Plasma Concentration Ratio
CSF: plasma ratio of ondansetron at the time of obtaining the CSF sample
Time frame: 0-180 min from the beginning of infusion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label Infusion Ondansetron | CSF to Plasma Concentration Ratio | 0.15 Ratio | Standard Deviation 0.05 |