N/A Completed N=19 Other

CSF Pharmacokinetics of Ondansetron

Postoperative Pain

Source: ClinicalTrials.gov NCT02901054 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2018

Primary outcomePrimary: CSF to Plasma Concentration Ratio — 0.15 Ratio

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY CSF to Plasma Concentration Ratio	0.15	—

Eligibility Criteria

Inclusion Criteria

Age between 18 and 70 years old;
Patients planned to undergo hip or knee arthroplasty with spinal anesthesia;
Ability to provide informed consent

Exclusion Criteria

Not giving consent to participate in the study;
Patients with history of or current hepatic or renal insufficiency;
Patients with BMI ≥ 33;
Patients with heart failure or active arrhythmias;
Patients with severe systemic disease that is a constant threat to life;
Contraindication or allergy to ondansetron;
Pregnancy or lactation.
Prisoners

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Data sourced from ClinicalTrials.gov (NCT02901054). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.