Frequency of Occurrence and Risk Factors of Postoperative Nausea and Vomiting During Elective C-section Under Spinal Anesthesia With Preventive Medication

Recruiting

• Conditions: Nausea and Vomiting, Postoperative; Cesarean Delivery; Spinal Anesthesia; Antiemetic Therapy

• Registration Number: NCT06927830
• Lead Sponsor: University of Liege

Brief Summary

The aim of this study is to learn about the incidence and risk factors of nausea and vomiting during planned caesarean section under spinal anesthesia.

The main question it aims to answer is : What are the incidence and risks factors of postoperative nausea and vomiting (NV) during planned caesarean section under spinal anesthesia with administration of intrathecal morphine and multimodal antiemetic prophylaxis ?

Patients who will be managed according to the standard protocol in use in the department will have to answer specific questions about NV in the post-interventional recovery room and on 2 further visits in the first 24 hours post-caesarean section.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-19
• Status Verified: 2025-04
• Study First Submitted: 2025-04-07
• Study First Submitted QC: 2025-04-14
• Last Update Submitted: 2025-04-14
• Study First Posted: 2025-04-15
• Last Update Posted: 2025-04-15
• Primary Completion: 2026-03
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of nausea and vomiting	From cesarean section to the 24th postoperative hour	The primary endpoint will be the incidence of PONV, including the incidence of nausea requiring rescue medication; the incidence of nausea delaying resumption of oral intake (drinks, food or analgesics); and the incidence of vomiting.

Secondary Outcome Measures

Name	Time	Method
Risk factors of PONV	From enrollment to the 24th postoperative hour	Risk factors will be evaluated among maternal, obstetrical, neonatal, procedural and anesthetic data.

Trial Locations

Locations (2)

CHU de Liège - site de Notre-Dame des Bruyères; 🇧🇪 Chenée, Belgium

Hôpital de la Citadelle - site Citadelle; 🇧🇪 Liège, Belgium