Actively Recruiting
Ondansetron Use for Preventing Pruritus in Patients Undergoing Cesarean Section
Led by Wayne State University · Updated on 2025-03-28
66
Participants Needed
1
Research Sites
66 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Opioids are often added with a local anesthetic to enhance the duration and quality of spinal anesthesia for cesarean delivery patients. However, spinal opioids are associated with a wide variety of side effects such as nausea, vomiting, (N/V) and pruritus (itching). The occurrence of pruritus can vary between 30% and 100% making pruritus the most common side-effect of intrathecal opioids and this rate is even higher in pregnant patients. Pruritus may require treatment which can be ineffective or sometimes reverse the analgesic effect of the opioids. Ondansetron is a safe and very commonly used Serotonin receptor antagonist treatment for local anesthetic opioid-induced pruritus used in pregnancy. The effect of different administration times of ondansetron in reducing pruritus or N/V in cesarean section (CS) cases has not been extensively studied and thus, this prospective study can help guide future clinical management of side effects caused by spinal intrathecal morphine administration.
CONDITIONS
Official Title
Ondansetron Use for Preventing Pruritus in Patients Undergoing Cesarean Section
Who Can Participate
Eligibility Criteria
You may qualify if you...
- American Society of Anesthesiologists (ASA) physical status 1-3
- Adult women aged 18 to 50 years scheduled for elective cesarean delivery under spinal anesthesia
- Willing and able to provide written informed consent
You will not qualify if you...
- ASA physical status greater than grade 3
- Allergies to local anesthetics, opioids, or ondansetron
- Coagulopathies preventing spinal anesthesia
- Severe pre-eclampsia or eclampsia
- Presence of pruritus before spinal anesthesia
- Psychiatric or language impairments affecting pain assessment
- Insufficient understanding of the pain scoring system
- Use of other regional anesthesia techniques
- Use of more than 100 mg daily morphine equivalent
- Cardiac conditions preventing spinal anesthesia (e.g., congestive heart failure, valve pathology)
- Neurological conditions preventing spinal anesthesia
- Use of drugs that interact with ondansetron, including apomorphine, phenytoin, carbamazepine, rifampicin, tramadol, chemotherapy drugs
- Use of drugs that prolong QTc interval, including certain antibiotics, antifungals, antiarrhythmics, antidepressants, antipsychotics
- Use of drugs that may cause serotonin syndrome, including SSRIs, SNRIs, certain antidepressants, carbamazepine, valproic acid, triptans, chronic pain medications, lithium, dextromethorphan, linezolid, ritonavir
- Known hypersensitivity to ondansetron or its components
- History of QTc prolongation or Torsade de Pointes
- Concurrent use of selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Detroit Medical Center- Hutzel Women's Hospital
Detroit, Michigan, United States, 48201
Actively Recruiting
Research Team
J
Justin Hruska, MD
CONTACT
G
George M McKelvey, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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