Understanding nausea and vomiting after elective C-sections under spinal anesthesia
Incidence and Risk Factors of Postoperative Nausea and Vomiting (PONV) During Elective C-Section Under Spinal Anesthesia With Multimodal Antiemetic Prophylaxis
This study looks at how often women feel nauseous or vomit after having a planned C-section with spinal anesthesia and what might cause it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Liege Academic / other |
| Locations | 2 sites (Chenée and 1 other locations) |
| Trial ID | NCT06927830 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the frequency and risk factors associated with postoperative nausea and vomiting (PONV) in patients undergoing elective cesarean sections with spinal anesthesia. Participants will be monitored for nausea and vomiting in the recovery room and during follow-up visits within the first 24 hours post-surgery. The study will utilize a standard management protocol that includes the administration of intrathecal morphine and multimodal antiemetic prophylaxis. Data collected will help identify the incidence of PONV and the factors that may contribute to its occurrence.
Who should consider this trial
Good fit: Ideal candidates are patients requiring elective cesarean sections at a gestational age greater than 37 weeks with a single fetus.
Not a fit: Patients with contraindications to spinal anesthesia or those who have experienced nausea and vomiting in the 24 hours prior to the procedure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for preventing nausea and vomiting in patients undergoing cesarean sections.
How similar studies have performed: Previous studies have shown varying success in managing postoperative nausea and vomiting in similar surgical contexts, indicating that this area of research is both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Any patient requiring elective caesarean section under spinal anesthesia, at a gestational age \>37 weeks of amenorrhea in the context of a single-fetal pregnancy. Exclusion Criteria: Failure to understand the French language; Contraindication to locoregional anesthesia; Nausea and/or vomiting in the 24 hours preceding the procedure; Type 1 or type 2 insulin-requiring non-gestational diabetes; Allergy or contraindication to one of the products used in the usual management protocol; Severe preeclampsia; Height \<150 cm
Where this trial is running
Chenée and 1 other locations
- CHU de Liège - site de Notre-Dame des Bruyères — Chenée, Belgium (Recruiting)
- Hôpital de la Citadelle - site Citadelle — Liège, Belgium (Not_yet_recruiting)
Study contacts
- Study coordinator: Thibault Michot, M.D.
- Email: tmichot@chuliege.be
- Phone: +32 4 3234141
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.