Role of Prophylactic Antiemetics in Women Receiving Intrathecal Morphine and Lipophilic Opioids Added to Bupivacaine for Cesarean Section

NCT06704139 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: antiemetics cesarean section
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Because the majority of Caesarean deliveries are performed under neuraxial anaesthesia, Intrathecal morphine has become the gold standard for post-Caesarean delivery analgesia. However, postoperative nausea and vomiting (PONV) is the common side-effect of intrathecal morphine, affecting up to 60-80% of women without prophylaxis. PONV reduces maternal satisfaction and delays discharge from hospital, so it is important to prevent PONV in contemporary obstetric anaesthesia, particularly in the context of Enhanced Recovery After Surgery (ERAS) after Caesarean delivery. According to the meta-analysis by Lizhong Wang et al., combined 5-HT3 antagonists plus dexamethasone are more effective than mono-therapy in preventing PONV associated with intrathecal morphine after Caesarean delivery. But, the role of prophylactic antiemetics in women receiving intrathecal morphine and lipophilic opioids is still unclear. As antiemetics were shown to be less effective in women receiving intrathecal morphine than in those receiving epidural morphine, Lizhong Wang et al., performed a further subgroup analysis based on whether intrathecal morphine was combined with lipophilic opioids or not. Surprisingly, the results in women who received intrathecal morphine alone were similar to those in the primary analyses; however, in those who received intrathecal morphine and lipophilic opioids, there were no statistical differences in almost all comparisons. This raises the question of whether the combination of intrathecal lipophilic opioids contributed to the reduced efficacy of antiemetics in women receiving intrathecal morphine The objective of the current study is to examine the effect of prophylactic use of combined 5-HT3 antagonists plus dexamethasone to decrease the incidence of postoperative nausea and vomiting in parturients undergoing CS under spinal anaesthesia who receive intrathecal morphine alone or combined with lipophilic opioids.

Conditions

Cesarean Section

Keywords

prophylactic antiemetics

Outcome Measures

Primary Outcomes (1)

• frequency of Postoperative Nausea and vomiting

  number of patients who will have Postoperative Nausea and vomiting

  24 hours

Secondary Outcomes (1)

• total amount of postoperative antiemetic consumption

  24 hours

Study Arms (2)

group 1

EXPERIMENTAL

Fifty patients will receive intrathecal morphine

Drug: Morphine - .25 mg; Drug: Ondansetron + Dexamethasone

group 2

EXPERIMENTAL

Fifty patients will receive intrathecal morphine and fentanyl

Drug: fentanyl + morphine; Drug: Ondansetron + Dexamethasone

Interventions

Morphine - .25 mg DRUG

Fifty patients will receive intrathecal morphine

group 1

fentanyl + morphine DRUG

Fifty patients will receive intrathecal morphine and fentanyl

group 2

Ondansetron + Dexamethasone DRUG

All patients will receive a compination of intravenous 4mg ondansteron and 8mg dexamethasone 15 minutes before spinal anathesia

group 1; group 2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age from 19 to 40 years old.
• Singleton pregnancies with a gestational age of at least 37 weeks.
• pregnant women are scheduled for elective caesarean delivery.
• Patients with stable vital signs.
• Patients with normal laboratory investigations.
• patients undergoing spinal anaesthesia for caesarean delivery via Pfannenstiel incision with exteriorization of the uterus

You may not qualify if:

• Patient's refusal.
• Age \< 19 or \> 40 years.
• Height\<150 cm, weight \< 60 kg, body mass index (BMI) ≥40 kg/m2.
• Contraindications to spinal anaesthesia (Coagulopathy, increased intracranial pressure, or local skin infection).
• Patients with cardiac morbidities.
• hypertensive disorders of pregnancy as pre-eclampsia.
• peripartum bleeding.
• Patients with respiratory morbidities.
• Convulsions.
• Bleeding diathesis.
• Known allergy to any drugs used in this study.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• Aouad MT, Yazbeck-Karam VG, Nasr VG, El-Khatib MF, Kanazi GE, Bleik JH. A single dose of propofol at the end of surgery for the prevention of emergence agitation in children undergoing strabismus surgery during sevoflurane anesthesia. Anesthesiology. 2007 Nov;107(5):733-8. doi: 10.1097/01.anes.0000287009.46896.a7.

  PMID: 18073548 BACKGROUND

• Wang L, Huang J, Hu H, Chang X, Xia F. Commonly used antiemetics for prophylaxis of postoperative nausea and vomiting after Caesarean delivery with neuraxial morphine: a network meta-analysis. Br J Anaesth. 2024 Jun;132(6):1274-1284. doi: 10.1016/j.bja.2024.03.010. Epub 2024 Apr 15.

  PMID: 38627136 BACKGROUND

• Yurashevich M, Habib AS. Monitoring, prevention and treatment of side effects of long-acting neuraxial opioids for post-cesarean analgesia. Int J Obstet Anesth. 2019 Aug;39:117-128. doi: 10.1016/j.ijoa.2019.03.010. Epub 2019 Apr 26.

  PMID: 31202588 BACKGROUND

• 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.

  PMID: 33370462 BACKGROUND

MeSH Terms

Interventions

Morphine; Fentanyl; Ondansetron; Dexamethasone

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Imidazoles; Azoles; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, 3-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated

Central Study Contacts

Mina Maher Ywakim, resident doctor

CONTACT

+201275432177; menamaher7277@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients will be allocated in 1: 1 ratio into the two study groups using a web-based randomiser (https://www.randomizer.org/) to generate codes placed within sealed, opaque, sequentially numbered envelopes by a research assistant who will not be involved in patient care or assessment. This assistant also will prepare the study solutions in identical syringes that will be labelled ''study drug'' according to the assigned group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at anesthesia and ICU department Faculty of Medicine, Assiut University

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 25, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 25, 2024

Record last verified: 2024-11