Ondansetron Use for Preventing Pruritus in Patients Undergoing Cesarean Section

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.

Conditions

Pruritus Caused by Drug

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Study Overview

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Study Details

Study overview

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.

Timing of Ondansetron Use for Maximum Efficacy in Preventing Pruritus in Patients Undergoing Cesarean Section Under Spinal Anesthesia with Preservative Free Morphine.

Ondansetron Use for Preventing Pruritus in Patients Undergoing Cesarean Section

Condition
Pruritus Caused by Drug
Intervention / Treatment

-

Contacts and Locations

Detroit

Detroit Medical Center- Hutzel Women's Hospital, Detroit, Michigan, United States, 48201

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.
  • 15. Coadministration of drugs that would potentially lead to the development of serotonin syndrome. Including the following:
  • 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)

Ages Eligible for Study

18 Years to 50 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Wayne State University,

Study Record Dates

2025-12-01