Intrathecal MorphineNCT06837129
Intravenous Nalbuphine for Prevention of Intrathecal Morphine-induced Nausea and Vomiting in Patients Undergoing Cesarean Section: A Double-blind, Randomized Controlled Trial.
A study testing A single dose of 4 mg iv nalbuphine in people with Intrathecal Morphine and Caesarean Section, run by Thammasat University at 2 sites in Thailand.
Trial summary
We study efficacy of iv nalbuphine in prevention of intrathecal morphine-induced nausea and vomiting in patients undergoing cesarean section. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrathecal Morphine, Caesarean Section, Postoperative Nausea and Vomiting
- What is being tested?
- A single dose of 4 mg iv nalbuphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesThailand
- Study dates
- 15 Nov 2023to 20 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Elective cesarean section under spinal anesthesia
- age > 18 years
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Department of Anesthesiology, Faculty of Medicine, Thammasat University
Pathum Thani, Changwat Pathum Thani, 12121
Faculty of Medicine Thammasat University
Pathum Thani, Changwat Pathum Thani, 12121
About this study
We study efficacy of iv nalbuphine in prevention of intrathecal morphine-induced nausea and vomiting in patients undergoing cesarean section.
Read the 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.
- Conditions
- Intrathecal Morphine, Caesarean Section, Postoperative Nausea and Vomiting, Neuraxial Opioid
- Being tested
- A single dose of 4 mg iv nalbuphine
- Keywords
- Postoperative Nausea and Vomiting, intrathecal morphine, caesarean section, neuraxial opioid
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A single dose of 4 mg iv nalbuphineDrug
prevention of nausea vomiting
| Study group | Role | What they receive |
|---|---|---|
| IV NALBUPHINE | Experimental | A single dose of 4 MG IV nalbuphine is given after cord clamping in study group Receives: Drug: A single dose of 4 mg iv nalbuphine |
| conventional | No intervention | no medications is given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative nausea vomiting in 24 hours
Measured: 24 hours
Secondary outcomes (3)
Severity of nausea vomiting
Measured: 24 hours
Postoperative pain score
Measured: 24 hours
Incidence of pruritus
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start15 Nov 2023
- Primary completion15 Feb 2025
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrathecal MorphineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PREEYAPHAN ARUNAKUL, Thammasat University
- Investigators
- Assist. Prof. Dr. Preeyaphan Arunakul, M.D., FRCAT, Principal investigator, Thammasat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837129
- Sponsor's protocol ID
- MTU-EC-AN-1-130/66
- Status last verified
- Jan 2026
- First submitted
- 16 Feb 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Nalbuphine for Prevention of Intrathecal Morphine-induced Nausea and Vomiting in Patients Undergoing Cesarean Section: A Double-blind, Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06837129
- Acronym / sponsor ID
- MTU-EC-AN-1-130/66
- Conditions
- Intrathecal Morphine, Caesarean Section, Postoperative Nausea and Vomiting, Neuraxial Opioid
- Keywords
- Postoperative Nausea and Vomiting, intrathecal morphine, caesarean section, neuraxial opioid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 15 Feb 2025 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV NALBUPHINE | Experimental | Drug: A single dose of 4 mg iv nalbuphineA single dose of 4 MG IV nalbuphine is given after cord clamping in study group |
| conventional | No intervention | –no medications is given |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Elective cesarean section under spinal anesthesia
- age > 18 years
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A single dose of 4 mg iv nalbuphineprevention of nausea vomiting | Drug | IV NALBUPHINE |
Primary outcome
Incidence of postoperative nausea vomiting in 24 hours
Time frame: 24 hours
3 secondary outcomes
Severity of nausea vomiting
Time frame: 24 hours
Postoperative pain score
Time frame: 24 hours
Incidence of pruritus
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No
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Recruiting
Intrathecal Morphine Versus Intrathecal Dexmedetomidine Compared to Placebo for Postoperative Pain Relief After Spine Fixation Surgeries
Intrathecal Morphine, Intrathecal Dexmedetomidine
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Assist. Prof. Dr. Preeyaphan Arunakul, M.D., FRCAT principal investigator
Thammasat University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A single dose of 4 mg iv nalbuphine in people with Intrathecal Morphine and Caesarean Section, run by Thammasat University at 2 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative nausea vomiting in 24 hours (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.