Cesarean SectionPhase 4NCT00707824
Epidural Nalbuphine for Postcesarean Epidural Morphine Induced Pruritus
A Phase 4 study testing nalbuphine and NSS in people with Cesarean Section, run by Mahidol University at 1 site in Thailand.
Trial summary
Can epidural nalbuphine reduce incidence or severity of epidural morphine induced pruritus in patient undergoing cesarean section? Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section
- What is being tested?
- nalbuphine and NSS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2000to Feb 2006
- Phase
- Phase 4
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- full term parturient undergoing elective cesarean section
- ASA 1-2
Who cannot join
- drug or alcohol abuses
- contraindication for regional anesthesia
- received opioids within 12 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Epidural Nalbuphine for Prevention of Epidural Morphine Induced Pruritus
Can epidural nalbuphine reduce incidence or severity of epidural morphine induced pruritus in patient undergoing cesarean section?
Read the detailed description
182 parturients,ASA 1-2 undergoing cesarean section under epidural block were enrolled in the study. After obtaining informed consent,all received epidural anesthesia using 2% lidocaine with epinephrine 1:200000 via epidural cathetes at L2-3 or L3-4 in a volume suffient to achieve a T4 sensory level bilaterally.
After the umbilical cord was clamped,patients were assigned randomly to three groups.The placebo group,N-5 group,and N-10 group received 4 ml epidural solution containing morphine 4 mg plus either saline, nalbuphine 5 mg, and nalbuphine 10 mg respectively.At the post anesthetic care unit, intravenous pethidine PCA were administered for inadequate pain control.
Outcome measures :
Incidence and severity of postoperative pruritus Quality of pain control Side effects of epidural morphine and nalbuphine such as respiratory depression,sedation
- Conditions
- Cesarean Section
- Being tested
- nalbuphine, NSS
- Keywords
- pruritus, epidural morphine
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nalbuphineDrug
Also called nubain
nalbuphine 5 mg epidural
nalbuphineDrug
Also called nubaine
nalbuphine 10 mg epidural
NSSOther
Also called nornal saline
NSS
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | 1= placebo Receives: Other: NSS |
| 2 | Active comparator | 2=nalbuphine 5 mg Receives: Drug: nalbuphine |
| 3 | Active comparator | 3=nalbuphine 10 mg Receives: Drug: nalbuphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence and severity of pruritus
Measured: 24 hr
Secondary outcomes (1)
visual analogue pain score
Measured: 24 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2008 (estimated)
- Study startJun 2000
- Primary completionDec 2005
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Investigators
- Orawan Pongraweewan, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00707824
- Sponsor's protocol ID
- 110/2000
- Status last verified
- Feb 2006
- First submitted
- 29 Jun 2008
- Last updated
- 8 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Epidural Nalbuphine for Prevention of Epidural Morphine Induced Pruritus
- ClinicalTrials.gov ID
- NCT00707824
- Acronym / sponsor ID
- 110/2000
- Conditions
- Cesarean Section
- Keywords
- pruritus, epidural morphine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jun 2000
- Primary completion
- Dec 2005 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 1 Jul 2008 (estimated)
- 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.
Can epidural nalbuphine reduce incidence or severity of epidural morphine induced pruritus in patient undergoing cesarean section?
Detailed description
182 parturients,ASA 1-2 undergoing cesarean section under epidural block were enrolled in the study. After obtaining informed consent,all received epidural anesthesia using 2% lidocaine with epinephrine 1:200000 via epidural cathetes at L2-3 or L3-4 in a volume suffient to achieve a T4 sensory level bilaterally.
After the umbilical cord was clamped,patients were assigned randomly to three groups.The placebo group,N-5 group,and N-10 group received 4 ml epidural solution containing morphine 4 mg plus either saline, nalbuphine 5 mg, and nalbuphine 10 mg respectively.At the post anesthetic care unit, intravenous pethidine PCA were administered for inadequate pain control.
Outcome measures :
Incidence and severity of postoperative pruritus Quality of pain control Side effects of epidural morphine and nalbuphine such as respiratory depression,sedation
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Other: NSS1= placebo |
| 2 | Active comparator | Drug: nalbuphine2=nalbuphine 5 mg |
| 3 | Active comparator | Drug: nalbuphine3=nalbuphine 10 mg |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- full term parturient undergoing elective cesarean section
- ASA 1-2
Key exclusion criteria (3 listed)
- drug or alcohol abuses
- contraindication for regional anesthesia
- received opioids within 12 hours
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 |
|---|---|---|
| nalbuphineAlso: nubainnalbuphine 5 mg epidural | Drug | 2 |
| nalbuphineAlso: nubainenalbuphine 10 mg epidural | Drug | 3 |
| NSSAlso: nornal salineNSS | Other | 1 |
Primary outcome
incidence and severity of pruritus
Time frame: 24 hr
1 secondary outcome
visual analogue pain score
Time frame: 24 hr
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 8 Jul 2008.
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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.
Orawan Pongraweewan, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing nalbuphine and NSS in people with Cesarean Section, run by Mahidol University at 1 site 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 3 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 8 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 and severity of pruritus (time frame: 24 hr). 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 8 Jul 2008.