Using Ondansetron to Prevent Headaches After Spinal Anesthesia for Cesarean Delivery
Contribution of Ondansetron to Preventing Post-Dural Puncture Headaches Following Spinal Anesthesia for Cesarean Sections : A Randomized Controlled Trial
This study is testing if giving ondansetron before a cesarean delivery can help prevent headaches that some women get after spinal anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Mongi Slim Hospital Academic / other |
| Locations | 1 site (Tunis) |
| Trial ID | NCT06444737 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of ondansetron in preventing post-dural puncture headaches in parturients undergoing elective cesarean delivery with spinal anesthesia. Participants are randomly assigned to receive either intravenous ondansetron or a control solution of normal saline shortly before the procedure. The study aims to determine if ondansetron can significantly reduce the incidence of headaches that can occur after spinal anesthesia. Conducted over seven months, the trial includes women aged 18-45 who are at 37-41 weeks of gestation and classified as ASA 2.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-45, classified as ASA 2, and scheduled for elective cesarean delivery under spinal anesthesia.
Not a fit: Patients who require multiple attempts for spinal anesthesia or conversion to general anesthesia due to complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new preventive measure for post-dural puncture headaches, improving recovery and comfort for patients after cesarean delivery.
How similar studies have performed: While the efficacy of ondansetron for other indications is well-documented, this specific application for preventing post-dural puncture headaches is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged between 18-45 years * ASA 2 * Between 37 and 41 weeks of gestation * scheduled for elective caesarean delivery under spinal anaesthesia * To be delivered by unscheduled caesarean section whose indication does not involve a vital maternal or fetal emergency, according to the Lucas' classification Exclusion Criteria: * All patients who required : * more than two attempts for spinal anaesthesia * conversion to general anesthesia following failure of spinal anesthesia (defined as a sensory block level \<T6) or an intraoperative complication (such as hemorrhage or anaphylactic shock). As well as patients who have subsequently withdrawn their consent for participating to our study.
Where this trial is running
Tunis
- Mongi slim hospital — Tunis, Tunisia (Recruiting)
Study contacts
- Study coordinator: Mhamed Sami Mebazaa, professor
- Email: msmebazaa@gmail.com
- Phone: 22252589
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.