Intravenous Nalbuphine for Prevention of Intrathecal Morp... | NCT06837129

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

NCT06837129

Sponsor

Thammasat University

Status

Completed

Last Update Posted

Jan 28, 2026Actual

Enrollment

180Actual

Phase

Not Applicable

Conditions

Intrathecal Morphine
Caesarean Section
Postoperative Nausea and Vomiting
Neuraxial Opioid

Interventions

A single dose of 4 mg iv nalbuphine

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 15, 2023Actual

Primary Completion Date

Feb 15, 2025Actual

Completion Date

Feb 20, 2025Actual

First Submitted Date

Feb 16, 2025

First Submission Date that Met QC Criteria

Feb 16, 2025

First Posted Date

Feb 20, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2026

Last Update Posted Date

Jan 28, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

PREEYAPHAN ARUNAKUL, Assistant Professor Preeyaphan Arunakul MD, Thammasat UniversityPrincipal Investigator

Lead Sponsor

Thammasat UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
A single dose of 4 mg iv nalbuphine	Drug	prevention of nausea vomiting	IV NALBUPHINE

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of postoperative nausea vomiting in 24 hours		24 hours

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Assist. Prof. Dr. Preeyaphan Arunakul, M.D., FRCAT	Thammasat University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology, Faculty of Medicine, Thammasat University		Pathum Thani	Changwat Pathum Thani	12121	Thailand

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

PREEYAPHAN ARUNAKUL, Assistant Professor Preeyaphan Arunakul MD, Thammasat University

Unposted Events

Type	Date	Date Unknown
Release	Feb 23, 2026
Reset	Mar 13, 2026
Release	May 13, 2026

Violation Annotation

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

Estimated Results First Submitted Date

Feb 23, 2026

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D020250	Postoperative Nausea and Vomiting

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009325	Nausea
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D014839	Vomiting

ID	Term
D009266	Nalbuphine

Ancestor Terms

ID	Term
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds
D006572	Heterocyclic Compounds, Bridged-Ring
D006576	Heterocyclic Compounds, 4 or More Rings
D000072471	Heterocyclic Compounds, Fused-Ring
D010616	Phenanthrenes
D011084	Polycyclic Aromatic Hydrocarbons
D011083	Polycyclic Compounds

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 23, 2026			Mar 13, 2026
May 13, 2026			Jun 8, 2026