Postoperative PainPhase 2NCT02716129
The Effect of Adding Nalbuphine to Intrathecal Morphine on Analgesic Efficacy and Side Effects After Cesarean Section
A Phase 2 study testing Morphine and Morphine plus Nalbuphine in people with Postoperative Pain, run by Abdelrady S Ibrahim, MD at 1 site in Egypt.
Trial summary
The primary endpoint of this study is to investigate the effect of adding nalbuphine to intrathecal morphine on quality of postoperative analgesia and Morphine related side effects post- cesarean delivery. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Morphine and Morphine plus Nalbuphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2016to Oct 2017
- Phase
- Phase 2
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients
- age between 16 to 40 years
- ASA physical status I - II
Who cannot join
- Infection at the site of injection.
- Coagulopathy or other bleeding diathesis.
- Preexisting neurologic deficits.
- History of hypersensitivity to any of the given the drugs.
- Inability to communicate with the investigator and the hospital staff.
- History of chronic opioid us
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-cesarean Section Analgesic Potency and Side Effects of Intrathecal Morphine and Nalbuphine
The primary endpoint of this study is to investigate the effect of adding nalbuphine to intrathecal morphine on quality of postoperative analgesia and Morphine related side effects post- cesarean delivery.
Read the detailed description
The study will be performed in Assiut University Hospitals, after obtaining approval from the local ethics committee and written informed patient consent. All patients will have a peripheral IV cannula 18 G inserted; standard non-invasive monitors will be applied. All the patients will be preloaded with 10 ml/kg Ringer's lactate solution intravenous. Intrathecal block under strict aseptic conditions will be performed in sitting position at L3-4 or L4-5 inter-spinous space with 25G pencil-point spinal needle. All patients will receive intrathecal 10 mg of 0.5% hyperbaric bupivacaine.
- Conditions
- Postoperative Pain
- Being tested
- Morphine, Morphine plus Nalbuphine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
Also called Infumorph
38 patients of this group will receive 10 mg of 0.5% hyperbaric bupivacaine (Buvanest Spinal 0.5% Heavy) with 0.2 mg morphine (Infumorph - Injection 10 mg/mL) in 0.5 ml volume (total volume 2.5 mL). Patients will be preloaded with 10 ml/kg Ringer's lactate solution intravenous.
Morphine plus NalbuphineDrug
Also called Infumorph and NALUFIN
39 patients of this group will receive 10 mg of 0.5% hyperbaric bupivacaine (Buvanest Spinal 0.5% Heavy) with 0.5 mg morphine (Infumorph - Injection 10 mg/mL) plus 0.2 mg nalbuphine (NALUFIN 20MG/ML AMP) in 0.5 ml volume (total volume 2.5 mL). Patients will be preloaded with 10 ml/kg Ringer's lactate solution intravenous.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Morphine group Receives: Drug: Morphine |
| Group 2 | Active comparator | Morphine plus Nalbuphine group Receives: Drug: Morphine plus Nalbuphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Visual Analogue Score
Measured: 24 hours
Secondary outcomes (5)
Incidence of postoperative itching
Visual Analogue Score
Measured: 24 hours
number of participants with incidence of postoperative nausea
Patients number
Measured: 24 hours
number of participants with incidence of postoperative vomiting
Patients number
Measured: 24 hours
number of participants with incidence of postoperative postdural puncture headache
Patients number
Measured: 24 hours
number of participants with incidence of postoperative respiratory depression
Patients number
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 posted23 Mar 2016 (estimated)
- Study startJul 2016
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abdelrady S Ibrahim, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abdelrady S Ibrahim, MD, Assiut University
- Investigators
- Abdelrady S Ibrahim, MD, Principal investigator, Assistant professor of anesthesia and intensive care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02716129
- Sponsor's protocol ID
- IRB0000871235
- Status last verified
- Dec 2017
- First submitted
- 15 Mar 2016
- Last updated
- 27 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Culebras X, Gaggero G, Zatloukal J, Kern C, Marti RA. Advantages of intrathecal nalbuphine, compared with intrathecal morphine, after cesarean delivery: an evaluation of postoperative analgesia and adverse effects. Anesth Analg. 2000 Sep;91(3):601-5. doi: 10.1097/00000539-200009000-00019.
PubMed 10960384
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-cesarean Section Analgesic Potency and Side Effects of Intrathecal Morphine and Nalbuphine
- ClinicalTrials.gov ID
- NCT02716129
- Acronym / sponsor ID
- IRB0000871235
- Conditions
- Postoperative Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Abdelrady S Ibrahim, MDUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 23 Mar 2016 (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.
The primary endpoint of this study is to investigate the effect of adding nalbuphine to intrathecal morphine on quality of postoperative analgesia and Morphine related side effects post- cesarean delivery.
Detailed description
The study will be performed in Assiut University Hospitals, after obtaining approval from the local ethics committee and written informed patient consent. All patients will have a peripheral IV cannula 18 G inserted; standard non-invasive monitors will be applied. All the patients will be preloaded with 10 ml/kg Ringer's lactate solution intravenous. Intrathecal block under strict aseptic conditions will be performed in sitting position at L3-4 or L4-5 inter-spinous space with 25G pencil-point spinal needle. All patients will receive intrathecal 10 mg of 0.5% hyperbaric bupivacaine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: MorphineMorphine group |
| Group 2 | Active comparator | Drug: Morphine plus NalbuphineMorphine plus Nalbuphine group |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female patients
- age between 16 to 40 years
- ASA physical status I - II
Key exclusion criteria (6 listed)
- Infection at the site of injection.
- Coagulopathy or other bleeding diathesis.
- Preexisting neurologic deficits.
- History of hypersensitivity to any of the given the drugs.
- Inability to communicate with the investigator and the hospital staff.
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 |
|---|---|---|
| MorphineAlso: Infumorph38 patients of this group will receive 10 mg of 0.5% hyperbaric bupivacaine (Buvanest Spinal 0.5% Heavy) with 0.2 mg morphine (Infumorph - Injection 10 mg/mL) in 0.5 ml volume (total volume 2.5 mL). Patients will be preloaded with 10 ml/kg Ringer's lactate solution intravenous. | Drug | Group 1 |
| Morphine plus NalbuphineAlso: Infumorph and NALUFIN39 patients of this group will receive 10 mg of 0.5% hyperbaric bupivacaine (Buvanest Spinal 0.5% Heavy) with 0.5 mg morphine (Infumorph - Injection 10 mg/mL) plus 0.2 mg nalbuphine (NALUFIN 20MG/ML AMP) in 0.5 ml volume (total volume 2.5 mL). Patients will be preloaded with 10 ml/kg Ringer's lactate solution intravenous. | Drug | Group 2 |
Primary outcome
Postoperative pain
Time frame: 24 hours
Visual Analogue Score
5 secondary outcomes
Incidence of postoperative itching
Time frame: 24 hours
number of participants with incidence of postoperative nausea
Time frame: 24 hours
number of participants with incidence of postoperative vomiting
Time frame: 24 hours
number of participants with incidence of postoperative postdural puncture headache
Time frame: 24 hours
number of participants with incidence of postoperative respiratory depression
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 27 Dec 2017.
- Background: PubMed 10960384Culebras X, Gaggero G, Zatloukal J, Kern C, Marti RA. Advantages of intrathecal nalbuphine, compared with intrathecal morphine, after cesarean delivery: an evaluation of postoperative analgesia and adverse effects. Anesth Analg. 2000 Sep;91(3):601-5. doi: 10.1097/00000539-200009000-00019.
- Individual participant dataSharing planned: Undecided
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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.
Abdelrady S Ibrahim, MD principal investigator
Assistant professor of anesthesia and intensive care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Morphine and Morphine plus Nalbuphine in people with Postoperative Pain, run by Abdelrady S Ibrahim, MD 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 3 inclusion and 6 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 27 Dec 2017. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Postoperative pain (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02716129, which also lists 1 linked publication.
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 27 Dec 2017.