Intravenous Nalbuphine for Prevention of Intrathecal Morphine-induced Nausea and Vomiting in Patients Undergoing Cesarean Section: A Double-blind, Randomized Controlled Trial.

NCT06837129 | Completed

• 1 other identifier: MTU-EC-AN-1-130/66
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

Brief Summary

We study efficacy of iv nalbuphine in prevention of intrathecal morphine-induced nausea and vomiting in patients undergoing cesarean section.

Conditions

Intrathecal Morphine; Caesarean Section; Postoperative Nausea and Vomiting; Neuraxial Opioid

Keywords

Postoperative Nausea and Vomiting; intrathecal morphine; caesarean section; neuraxial opioid

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative nausea vomiting in 24 hours

  24 hours

Secondary Outcomes (3)

• Severity of nausea vomiting

  24 hours

• Postoperative pain score

  24 hours

• Incidence of pruritus

  24 hours

Study Arms (2)

IV NALBUPHINE

EXPERIMENTAL

A single dose of 4 MG IV nalbuphine is given after cord clamping in study group

Drug: A single dose of 4 mg iv nalbuphine

conventional

NO INTERVENTION

no medications is given

Interventions

A single dose of 4 mg iv nalbuphine DRUG

prevention of nausea vomiting

IV NALBUPHINE

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Elective cesarean section under spinal anesthesia
• age \> 18 years

You may not qualify if:

• Patients with known allergy to medications used in this study (nalbuphine, bupivacaine or morphine)
• Patient with medical conditions which spinal anesthesia is contraindicated ie. heart diseases, renal or hepatic impairment, obesity \>=100 kilograms
• Patients with history of postoperative nausea and vomiting (PONV) or motion sickness who may have preexisting risk factors for PONV
• Patient with known history of drug abuse
• Unwilling to participate in the study

Sponsors & Collaborators

• Thammasat University: lead

Study Sites (2)

Department of Anesthesiology, Faculty of Medicine, Thammasat University

Pathum Thani, Changwat Pathum Thani, 12121, Thailand

Location

Faculty of Medicine Thammasat University

Pathum Thani, Changwat Pathum Thani, 12121, Thailand

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Nalbuphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

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

Study Officials

• Assist. Prof. Dr. Preeyaphan Arunakul, M.D., FRCAT

  Thammasat University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Preeyaphan Arunakul MD

Study Record Dates

• First Submitted: February 16, 2025
• First Posted: February 20, 2025
• Study Start: November 15, 2023
• Primary Completion: February 15, 2025
• Study Completion: February 20, 2025
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (2)