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

January 26, 2026 updated by: PREEYAPHAN ARUNAKUL, Thammasat University
We study efficacy of iv nalbuphine in prevention of intrathecal morphine-induced nausea and vomiting in patients undergoing cesarean section.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

IV nalbuphine has been proved to help prevent intrathecal morphine-induced pruritus in some studies but results in nausea vomiting prevention have not been well studied. In Thailand, most caesarean section is done under spinal anesthesia with intrathecal morphine, proving that iv nalbuphine is effective would be beneficial for our population. This study aims to see whether 4 mg of nalbuphine is effective in reducing incidence of intrathecal morphine-related nausea vomiting in parturient who underwent C-section under spinal anesthesia with 0.2 mg of intrathecal morphine.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Changwat Pathum Thani
      • Pathum Thani, Changwat Pathum Thani, Thailand, 12121
        • Department of Anesthesiology, Faculty of Medicine, Thammasat University
      • Pathum Thani, Changwat Pathum Thani, Thailand, 12121
        • Faculty of Medicine Thammasat University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IV NALBUPHINE
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
prevention of nausea vomiting
No Intervention: conventional
no medications is given

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of postoperative nausea vomiting in 24 hours
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Severity of nausea vomiting
Time Frame: 24 hours
24 hours
Postoperative pain score
Time Frame: 24 hours
24 hours
Incidence of pruritus
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thammasat University

Investigators

  • Principal Investigator: Assist. Prof. Dr. Preeyaphan Arunakul, M.D., FRCAT, Thammasat University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2023

Primary Completion (Actual)

February 15, 2025

Study Completion (Actual)

February 20, 2025

Study Registration Dates

First Submitted

February 16, 2025

First Submitted That Met QC Criteria

February 16, 2025

First Posted (Actual)

February 20, 2025

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTU-EC-AN-1-130/66

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Caesarean Section

Clinical Trials on A single dose of 4 mg iv nalbuphine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe