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

NCT ID: NCT06927830

Last Updated: 2025-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-19

Study Completion Date

2026-04-30

Brief Summary

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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

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Conditions

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Nausea and Vomiting, Postoperative Cesarean Delivery Spinal Anesthesia Antiemetic Therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Liege

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Liège - site de Notre-Dame des Bruyères

Chenée, , Belgium

Site Status RECRUITING

Hôpital de la Citadelle - site Citadelle

Liège, , Belgium

Site Status NOT_YET_RECRUITING

Countries

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Belgium

Central Contacts

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Thibault Michot, M.D.

Role: CONTACT

+32 4 3234141

Fernande J Lois, M.D., PhD

Role: CONTACT

Facility Contacts

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Thibault Michot, M.D.

Role: primary

+32 4 3234141

Pierre-Yves Dewandre, M.D., PhD

Role: backup

+ 32 4 3233654

Géraldine Lambert, M.D.

Role: primary

+32 4 3217154

References

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Tan HS, Cooter M, George RB, Habib AS. A risk score for postoperative nausea and/or vomiting in women undergoing cesarean delivery with intrathecal morphine. Int J Obstet Anesth. 2020 Nov;44:126-130. doi: 10.1016/j.ijoa.2020.08.008. Epub 2020 Aug 20.

Reference Type BACKGROUND
PMID: 32950029 (View on PubMed)

Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.

Reference Type BACKGROUND
PMID: 10485781 (View on PubMed)

Balki M, Carvalho JC. Intraoperative nausea and vomiting during cesarean section under regional anesthesia. Int J Obstet Anesth. 2005 Jul;14(3):230-41. doi: 10.1016/j.ijoa.2004.12.004.

Reference Type BACKGROUND
PMID: 15935649 (View on PubMed)

Sentilhes L, Schmitz T, Madar H, Bouchghoul H, Fuchs F, Garabedian C, Korb D, Nouette-Gaulain K, Pecheux O, Sananes N, Sibiude J, Senat MV, Goffinet F. [The cesarean procedure: Guidelines for clinical practice from the French College of Obstetricians and Gynecologists]. Gynecol Obstet Fertil Senol. 2023 Jan;51(1):7-34. doi: 10.1016/j.gofs.2022.10.002. Epub 2022 Oct 11. French.

Reference Type BACKGROUND
PMID: 36228999 (View on PubMed)

Bollag L, Lim G, Sultan P, Habib AS, Landau R, Zakowski M, Tiouririne M, Bhambhani S, Carvalho B. Society for Obstetric Anesthesia and Perinatology: Consensus Statement and Recommendations for Enhanced Recovery After Cesarean. Anesth Analg. 2021 May 1;132(5):1362-1377. doi: 10.1213/ANE.0000000000005257.

Reference Type BACKGROUND
PMID: 33177330 (View on PubMed)

Wong JY, Carvalho B, Riley ET. Intrathecal morphine 100 and 200 mug for post-cesarean delivery analgesia: a trade-off between analgesic efficacy and side effects. Int J Obstet Anesth. 2013 Jan;22(1):36-41. doi: 10.1016/j.ijoa.2012.09.006. Epub 2012 Nov 15.

Reference Type BACKGROUND
PMID: 23159009 (View on PubMed)

Roofthooft E, Joshi GP, Rawal N, Van de Velde M; PROSPECT Working Group* of the European Society of Regional Anaesthesia and Pain Therapy and supported by the Obstetric Anaesthetists' Association. PROSPECT guideline for elective caesarean section: updated systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2021 May;76(5):665-680. doi: 10.1111/anae.15339. Epub 2020 Dec 28.

Reference Type BACKGROUND
PMID: 33370462 (View on PubMed)

Caughey AB, Wood SL, Macones GA, Wrench IJ, Huang J, Norman M, Pettersson K, Fawcett WJ, Shalabi MM, Metcalfe A, Gramlich L, Nelson G, Wilson RD. Guidelines for intraoperative care in cesarean delivery: Enhanced Recovery After Surgery Society Recommendations (Part 2). Am J Obstet Gynecol. 2018 Dec;219(6):533-544. doi: 10.1016/j.ajog.2018.08.006. Epub 2018 Aug 15.

Reference Type BACKGROUND
PMID: 30118692 (View on PubMed)

Van De Velde M, Vercauteren M, Stockman W, Roelants F, Coppens M, Bauters M, Ickx B, Dewandre PY, Soetens F, Cant P, Van Keer L, Gautier P. Recommendations and guidelines for obstetric anesthesia in Belgium. Acta Anaesthesiol Belg. 2013;64(3):97-104. No abstract available.

Reference Type BACKGROUND
PMID: 24279198 (View on PubMed)

Other Identifiers

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B7072024000148

Identifier Type: REGISTRY

Identifier Source: secondary_id

2024/534

Identifier Type: -

Identifier Source: org_study_id

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