Clinical trial NCT06297499: Ondansetron Use for Preventing Pruritus in Patients Undergoing Cesarean Section
Official title: Timing of Ondansetron Use for Maximum Efficacy in Preventing Pruritus in Patients Undergoing Cesarean Section Under Spinal Anesthesia with Preservative Free Morphine.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Pruritus Caused by Drug
Keywords: Cesarean Section
Intrathecal Morphine
Ondansetron
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized double-blinded trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

The primary aim of this study is to observe in a randomized double-blinded trial if the timing of prophylactic administration of intravenous ondansetron can reduce the incidence and severity of intrathecal morphine-induced pruritus in patients undergoing Cesarean section (CS). The secondary aim is to establish the effect of intravenous ondansetron given at different time intervals following CS for postoperative nausea and vomiting (PONV). The primary study hypothesis is that patients receiving prophylactic intravenous ondansetron (15-30 minutes prior to intrathecal morphine) will experience a lower incidence and severity of intrathecal morphine-induced pruritus than patients receiving ondansetron administered at the time of umbilical cord clamping. The secondary study hypothesis is that CS patients receiving intravenous ondansetron 15-30 minutes prior to intrathecal morphine will have less nausea and vomiting than patients receiving ondansetron administered at the time of umbilical cord clamping.

As the effect of prophylactic administration of ondansetron in reducing pruritus or Nausea/Vomiting in cesarean section (CS) cases has not been studied and thus, this prospective study may help guide future clinical management of side effects caused by intrathecal morphine administration.

Eligibility criteria: Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) physical status 1-3
2. Adult parturient (18 -50 years of age) scheduled to undergo elective cesarean delivery under spinal anesthesia
3. Patients must be willing and cognitively able to give written informed study consent

Exclusion Criteria:

1. Patients with an ASA physiological assessment greater than grade 3
2. Allergies to local anesthetics, opioids, or ondansetron
3. Coagulopathies precluding provision of spinal anesthesia
4. Pre-eclampsia with severe features
5. Eclampsia
6. Pre-intrathecal pruritus
7. Psychiatric or language deficiencies affecting assessment of pain
8. Insufficient understanding of the pain scoring system
9. Patients who receive any other regional anesthesia techniques
10. Patients on higher than a 100mg of daily morphine equivalent
11. Cardiac issues that would preclude spinal anesthesia (Congestive heart failure, Mitral or Aortic valve pathology.
12. Confounding neural issues that would preclude spinal anesthesia.
13. Coadministration of drugs that would potentially interact with ondansetron. Including Apomorphine, Phenytoin, Carbamazepine, Rifampicin, Tramadol and Chemotherapy drugs.
14. Coadministration of drugs that would potentially prolong QTc interval. Including Antiarrhythmic, Antidepressants, Antipsychotics, and the following list of medications.

    a. Levofloxacin, Ciprofloxacin, Gatifloxacin, Moxifloxacin, Clarithromycin, Erythromycin, Ketoconazole, Itraconazole, Cisapride, Sumatriptan, Zolmitriptan, Arsenic, Dolasetron, Methadone
15. Coadministration of drugs that would potentially lead to the development of serotonin syndrome. Including the following:

    a. Selective serotonin reuptake inhibitors, Serotonin and norepinephrine reuptake inhibitors, antidepressants, carbamazepine , valproic acid, triptans, Chronic pain medications prior to procedure (Fentanyl, Hydrocodone, Meperidine, Oxycodone, tramadol),Lithium, dextromethorphan, Linezolid and Ritonavir
16. Patients having the following

    1. Patients known to have hypersensitivity (e.g., anaphylaxis) to ondansetron or any components of the formulation
    2. Concomitant use of apomorphine
    3. History of QTc interval prolongation (QTc \>440) and Torsade de Pointes
    4. Serotonin syndrome
    5. Phenylketonuric patients
    6. Concurrent use of selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs)

Primary outcomes:
measure: Pruritus parameters in Post anesthesia Care Unit (PACU)
timeFrame: Assessment during 1st post-operative hour in PACU
measure: Pruritus severity in Post anesthesia Care Unit (PACU)
timeFrame: Assessment during 1st post-operative hour in PACU
measure: Pruritus parameters PACU
timeFrame: Assessment during 24 hours post-operative period
measure: Pruritus severity PACU
timeFrame: Assessment during 24 hours post-operative period
measure: Rescue Pruritus Treatment medication
timeFrame: Measured in the 24 hour period from initial study treatment (30 minute period before intrathecal morphine administration.
measure: Nausea PACU
timeFrame: Assessment every 15 minutes for 1 hour
measure: Nausea Post PACU
timeFrame: our period after patients left PACU from initial study treatment (30 minute period before intrathecal morphine administration.
Secondary outcomes:
measure: Post-operative Pain
timeFrame: Taken while patient in PACU at 0 minutes, 15 minutes, 30 minutes, 45 minutes and 60 min. Post PACU patient assessment at at 8 hours, 16 hours, 24 hours post-operative period
Other outcomes:
measure: Peripheral oxygen saturation- Mother
timeFrame: At Delivery, then at 30 minutes, 60 minutes, 90 minutes, 2 hours, 8 hours,16 hours, 24 hours post-delivery
measure: Peripheral oxygen saturation- Infant
timeFrame: At Delivery, then at 30 minutes, 60 minutes, 90 minutes, 2 hours, 8 hours,16 hours, 24 hours post-delivery
measure: Heart rate- Mother
timeFrame: At Delivery, then at 30 minutes, 60 minutes, 90 minutes, 2 hours, 8 hours,16 hours, 24 hours post-delivery
measure: Heart rate- Infant
timeFrame: At Delivery, then at 30 minutes, 60 minutes, 90 minutes, 2 hours, 8 hours,16 hours, 24 hours post-delivery
measure: Blood pressure Mother
timeFrame: At Delivery, then at 30 minutes, 60 minutes, 90 minutes, 2 hours, 8 hours,16 hours, 24 hours post-delivery
measure: Blood pressure- Infant
timeFrame: At Delivery, then at 30 minutes, 60 minutes, 90 minutes, 2 hours, 8 hours,16 hours, 24 hours post-delivery
measure: Electrocardiogram (ECG ) Mother
timeFrame: Within 2 hours of birth.
measure: ECG Infant
timeFrame: Within 2 hours of birth.
Locations:
city: Detroit
country: United States
facility: Detroit Medical Center- Hutzel Women's Hospital
state: Michigan
Study officials:
References: