protocolSection identificationModule nctId: NCT06297499, orgStudyIdInfo id: IRB-22-07-4803, briefTitle: Ondansetron Use for Preventing Pruritus In Patients Undergoing Cesarean Section, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Wayne State University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Pruritus Caused by Drug, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized double-blinded trial, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: The patient will be unaware of their grouping allotment. The outcomes assessor will be unaware of the patient grouping allotment., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: Ondansetron 8mg, outcomesModule primaryOutcomes measure: Pruritus parameters in Post anesthesia Care Unit (PACU), primaryOutcomes measure: Pruritus severity in Post anesthesia Care Unit (PACU), primaryOutcomes measure: Pruritus parameters PACU, primaryOutcomes measure: Pruritus severity PACU, primaryOutcomes measure: Rescue Pruritus Treatment medication, primaryOutcomes measure: Nausea PACU, primaryOutcomes measure: Nausea Post PACU, secondaryOutcomes measure: Post-operative Pain, otherOutcomes measure: Peripheral oxygen saturation- Mother, otherOutcomes measure: Peripheral oxygen saturation- Infant, otherOutcomes measure: Heart rate- Mother, otherOutcomes measure: Heart rate- Infant, otherOutcomes measure: Blood pressure Mother, otherOutcomes measure: Blood pressure- Infant, otherOutcomes measure: Electrocardiogram (ECG ) Mother, otherOutcomes measure: ECG Infant, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Detroit Medical Center- Hutzel Women's Hospital, city: Detroit, state: Michigan, zip: 48201, country: United States, contacts name: George M McKelvey, PhD, role: CONTACT, phone: 313-598-6036, email: gmckelve@dmc.org, contacts name: Justin Hruska, MD, role: CONTACT, phone: 402-432-0985, email: justinhruska1@gmail.com, geoPoint lat: 42.33143, lon: -83.04575, hasResults: False