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NCT Number: NCT06837129

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

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

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Key information

Conditions

Intrathecal Morphine Caesarean Section Nausea Neuraxial Opioid Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A single dose of 4 mg iv nalbuphine

Drug

prevention of nausea vomiting

Primary outcomes

  1. Incidence of postoperative nausea vomiting in 24 hours

    Time frame: 24 hours

Secondary outcomes

  1. Severity of nausea vomiting

    Time frame: 24 hours

  2. Postoperative pain score

    Time frame: 24 hours

  3. Incidence of pruritus

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Thammasat University

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 20, 2025
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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