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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06837129

Enrollment

180

Registered

2025-02-20

Start date

2023-11-15

Completion date

2025-02-20

Last updated

2026-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

DRUGA single dose of 4 mg iv nalbuphine

prevention of nausea vomiting

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Incidence of postoperative nausea vomiting in 24 hours	24 hours

Secondary

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

Countries

Thailand

Contacts

PRINCIPAL_INVESTIGATORAssist. Prof. Dr. Preeyaphan Arunakul, M.D., FRCAT

Thammasat University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026