Abdominal ObesityNCT03786562
The Effect of Intravenous Nalbuphine on PONV With Intrathecal Morphine in Abdominoplasty.
A study testing Intrathecal Morphine and Intrathecal Morphine + Intravenous Nalbuphine in people with Abdominal Obesity, run by Assiut University at 1 site in Egypt.
Trial summary
How effectively intravenous nalbuphine can reduce the incidence of PONV after intrathecal administration of morphine in abdominoplastic surgery. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Abdominal Obesity
- What is being tested?
- Intrathecal Morphine and Intrathecal Morphine + Intravenous Nalbuphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Mar 2019to Sep 2020
- 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 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients undergoing abdominoplasty under spinal anesthesia
- American Society of Anesthesiologists (ASA) class I and II.
Who cannot join
- allergy to local anesthetics
- bleeding diatheses
- local infection or sepsis
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University Hospital
Asyut
Eman Ismail, A professor
About this study
Official title: The Effect of Intravenous Nalbuphine on Postoperative Nausea and Vomiting With Intrathecal Morphine in Abdominoplastic Surgery.
How effectively intravenous nalbuphine can reduce the incidence of PONV after intrathecal administration of morphine in abdominoplastic surgery.
- Conditions
- Abdominal Obesity
- Being tested
- Intrathecal Morphine, Intrathecal Morphine + Intravenous Nalbuphine
- Medical subject headings
- Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal MorphineDrug
Group 1
Intrathecal Morphine + Intravenous NalbuphineDrug
Group 2
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Not described Receives: Drug: Intrathecal Morphine |
| Nalbuphine group | Active comparator | Not described Receives: Drug: Intrathecal Morphine + Intravenous Nalbuphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative nausea and vomiting
A verbal descriptive scale (VDS) was used to assess the severity of PONV. ( no nausea=0, severe nausea= 10)
by postoperative nausea and vomiting scale which range (o no nasuea to 10 sever vomating).
A verbal descriptive scale (VDS) was used to assess the severity of PONV .
Measured: 24 hours
Secondary outcomes (1)
postoperative pain and puririts.
Visual analogue scale (VAS) pain scores (no pain = 0, worst possible pain = 10).
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 posted26 Dec 2018
- Study start8 Mar 2019
- Primary completionMar 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal ObesityStudies of the same condition, open and under way.
- More trials run by Assiut 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman A. Ismail, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03786562
- Sponsor's protocol ID
- 01003060501
- Status last verified
- Mar 2019
- First submitted
- 19 Dec 2018
- Last updated
- 16 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intravenous Nalbuphine on Postoperative Nausea and Vomiting With Intrathecal Morphine in Abdominoplastic Surgery.
- ClinicalTrials.gov ID
- NCT03786562
- Acronym / sponsor ID
- 01003060501
- Conditions
- Abdominal Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 26 Dec 2018 (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.
How effectively intravenous nalbuphine can reduce the incidence of PONV after intrathecal administration of morphine in abdominoplastic surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Drug: Intrathecal Morphine |
| Nalbuphine group | Active comparator | Drug: Intrathecal Morphine + Intravenous Nalbuphine |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients undergoing abdominoplasty under spinal anesthesia
- American Society of Anesthesiologists (ASA) class I and II.
Key exclusion criteria (3 listed)
- allergy to local anesthetics
- bleeding diatheses
- local infection or sepsis
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 |
|---|---|---|
| Intrathecal MorphineGroup 1 | Drug | Placebo group |
| Intrathecal Morphine + Intravenous NalbuphineGroup 2 | Drug | Nalbuphine group |
Primary outcome
postoperative nausea and vomiting
Time frame: 24 hours
A verbal descriptive scale (VDS) was used to assess the severity of PONV. ( no nausea=0, severe nausea= 10) by postoperative nausea and vomiting scale which range (o no nasuea to 10 sever vomating). A verbal descriptive scale (VDS) was used to assess the severity of PONV .
1 secondary outcome
postoperative pain and puririts.
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrathecal Morphine and Intrathecal Morphine + Intravenous Nalbuphine in people with Abdominal Obesity, run by Assiut University at 1 site in Egypt.
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: status not confirmed, as of the sponsor's last update on 16 Mar 2020. 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 Egypt. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Bakri, Prof (+20882413201, mhbakri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative nausea and vomiting (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 16 Mar 2020.