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NCT Number: NCT06927830

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

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.

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Key information

Conditions

Nausea and Vomiting, Postoperative Antiemetic Therapy Cesarean Delivery Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Spinal Anesthesia Vomiting

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

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

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of nausea and vomiting

    Time frame: 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 outcomes

  1. Risk factors of PONV

    Time frame: From enrollment to the 24th postoperative hour

    Risk factors will be evaluated among maternal, obstetrical, neonatal, procedural and anesthetic data.

Study contacts

Contact information is provided by the study sponsor or research team.

Fernande J Lois, M.D., PhD

CONTACT

[email protected]

Thibault Michot, M.D.

CONTACT

[email protected]

+32 4 3234141

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study title

Incidence and Risk Factors of Postoperative Nausea and Vomiting (PONV) During Elective C-Section Under Spinal Anesthesia With Multimodal Antiemetic Prophylaxis

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 15, 2025
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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