PruritusPhase 2NCT04589429
Adding Nalbuphine for Control of Intrathecal Morphine Pruritus
A Phase 2 study testing Morphine 10 MG/ML and Nalbuphine Hydrochloride 10 MG/ML in people with Pruritus and Pain, Postoperative, run by Minia University at 1 site in Egypt.
Trial summary
Intrathecal morphine causes intense itching which is very bothersome. Nalbuphine antagonizes this effect when given intravenously. This trial is to find out if nalbuphine added to intrathecal morphine has an effect on morphine related pruritus while still maintaining adequate analgesia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pruritus, Pain, Postoperative, Nausea, Postoperative
- What is being tested?
- Morphine 10 MG/ML and Nalbuphine Hydrochloride 10 MG/ML
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2020to Mar 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients.
- Age 18-80yrs.
- Elective major abdominal surgery under general anesthesia.
Who cannot join
- Refusal to participate.
- Skin or systemic disease with itching. Any condition which precludes performing spinal injection
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
anesthesia&ICU department
Minya
sohair A Megalla, MD, 01200036447, Sohair.Adeeb@minia.edu.eg
About this study
Official title: Does Adding Nalbuphine to Intrathecal Morphine Reduce Morphine Induced Pruritus? A Randomized, Double Blind, Controlled Study.
Intrathecal morphine causes intense itching which is very bothersome. Nalbuphine antagonizes this effect when given intravenously. This trial is to find out if nalbuphine added to intrathecal morphine has an effect on morphine related pruritus while still maintaining adequate analgesia.
Read the detailed description
The study will be performed in MiniaUniversity Hospitals, after obtaining approval from the local ethics committee. All patients will have a peripheral IV cannula 18 G inserted; standard non-invasive monitors will be applied. Patients undergoing major abdominal surgery will be divided into 2 groups to receive intrathecal morphine 300 micrograms with or without nalbuphine 1mg prior to anesthesia. General anesthesia is then given to patients.
- Being tested
- Morphine 10 MG/ML, Nalbuphine Hydrochloride 10 MG/ML
- Keywords
- pruritus, intrathecal morphine, intrathecal nalbuphine
- Medical subject headings
- Pruritus, Pain, Postoperative, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine 10 MG/MLDrug
Also called morphine
intrathecal morphine 300 micrograms
Nalbuphine Hydrochloride 10 MG/MLDrug
Also called nalbuphine
intrathecal nalbuphine 2mg.
| Study group | Role | What they receive |
|---|---|---|
| MN group | Active comparator | intrathecal morphine 300 micrograms+2mg nalbuphine Receives: Drug: Morphine 10 MG/ML; Drug: Nalbuphine Hydrochloride 10 MG/ML |
| M group | Placebo comparator | intrathecal morphine 300 micrograms Receives: Drug: Morphine 10 MG/ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
pruritus
Pruritus score (1: no pruritus; 2: mild pruritus, treatment not requested; 3: moderate pruritus, treatment requested; 4: severe pruritus).
Measured: 2 hours postoperatively
pruritus
Pruritus score (1: no pruritus; 2: mild pruritus, treatment not requested; 3: moderate pruritus, treatment requested; 4: severe pruritus).
Measured: 4 hours postoperatively
pruritus
Pruritus score (1: no pruritus; 2: mild pruritus, treatment not requested; 3: moderate pruritus, treatment requested; 4: severe pruritus).
Measured: 24 hours postoperatively
Secondary outcomes (9)
postoperative pain
assessed with a verbal numeric pain score(NRS) where 0: no pain; 10: worst imaginable pain
Measured: 2 hours postoperative
postoperative pain
assessed with a verbal numeric pain score(NRS) where 0: no pain; 10: worst imaginable pain
Measured: 4 hours postoperative
postoperative pain
assessed with a verbal numeric pain score(NRS) where 0: no pain; 10: worst imaginable pain
Measured: 24 hours postoperative
postoperative nausea and vomiting
four-point rating score (1: no nausea or vomiting, 2: queasy, 3: severe nausea, 4: vomiting
Measured: 2 hours postoperative
postoperative nausea and vomiting
four-point rating score (1: no nausea or vomiting, 2: queasy, 3: severe nausea, 4: vomiting
Measured: 4 hours postoperative
postoperative nausea and vomiting
four-point rating score (1: no nausea or vomiting, 2: queasy, 3: severe nausea, 4: vomiting
Measured: 24 hours postoperative
Sedation
four-point sedation score (1: fully awake; 2: somnolent, responds to call; 3: somnolent, responds to tactile stimulation; 4: asleep, responds to painful stimulation).
Measured: 2 hours postoperative
Sedation
four-point sedation score (1: fully awake; 2: somnolent, responds to call; 3: somnolent, responds to tactile stimulation; 4: asleep, responds to painful stimulation).
Measured: 4 hours postoperative
Sedation
four-point sedation score (1: fully awake; 2: somnolent, responds to call; 3: somnolent, responds to tactile stimulation; 4: asleep, responds to painful stimulation).
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start15 Oct 2020
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PruritusStudies of the same condition, open and under way.
- More trials run by Minia 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sohair Adeeb, Minia University
- Investigators
- Sohair A Megalla, MD, Principal investigator, Anesthesia and ICU department, Faculty of Medicine, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589429
- Sponsor's protocol ID
- 678-9/2020
- Status last verified
- Feb 2021
- First submitted
- 27 Sep 2020
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Adding Nalbuphine to Intrathecal Morphine Reduce Morphine Induced Pruritus? A Randomized, Double Blind, Controlled Study.
- ClinicalTrials.gov ID
- NCT04589429
- Acronym / sponsor ID
- 678-9/2020
- Keywords
- pruritus, intrathecal morphine, intrathecal nalbuphine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 19 Oct 2020 (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.
Intrathecal morphine causes intense itching which is very bothersome. Nalbuphine antagonizes this effect when given intravenously. This trial is to find out if nalbuphine added to intrathecal morphine has an effect on morphine related pruritus while still maintaining adequate analgesia.
Detailed description
The study will be performed in MiniaUniversity Hospitals, after obtaining approval from the local ethics committee. All patients will have a peripheral IV cannula 18 G inserted; standard non-invasive monitors will be applied. Patients undergoing major abdominal surgery will be divided into 2 groups to receive intrathecal morphine 300 micrograms with or without nalbuphine 1mg prior to anesthesia. General anesthesia is then given to patients.
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 |
|---|---|---|
| MN group | Active comparator | Drug: Morphine 10 MG/ML, Drug: Nalbuphine Hydrochloride 10 MG/MLintrathecal morphine 300 micrograms+2mg nalbuphine |
| M group | Placebo comparator | Drug: Morphine 10 MG/MLintrathecal morphine 300 micrograms |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female patients.
- Age 18-80yrs.
- Elective major abdominal surgery under general anesthesia.
Key exclusion criteria (2 listed)
- Refusal to participate.
- Skin or systemic disease with itching. Any condition which precludes performing spinal injection
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 |
|---|---|---|
| Morphine 10 MG/MLAlso: morphineintrathecal morphine 300 micrograms | Drug | M group, MN group |
| Nalbuphine Hydrochloride 10 MG/MLAlso: nalbuphineintrathecal nalbuphine 2mg. | Drug | MN group |
Primary outcome
pruritus
Time frame: 2 hours postoperatively
Pruritus score (1: no pruritus; 2: mild pruritus, treatment not requested; 3: moderate pruritus, treatment requested; 4: severe pruritus).
pruritus
Time frame: 4 hours postoperatively
Pruritus score (1: no pruritus; 2: mild pruritus, treatment not requested; 3: moderate pruritus, treatment requested; 4: severe pruritus).
pruritus
Time frame: 24 hours postoperatively
Pruritus score (1: no pruritus; 2: mild pruritus, treatment not requested; 3: moderate pruritus, treatment requested; 4: severe pruritus).
9 secondary outcomes
postoperative pain
Time frame: 2 hours postoperative
postoperative pain
Time frame: 4 hours postoperative
postoperative pain
Time frame: 24 hours postoperative
postoperative nausea and vomiting
Time frame: 2 hours postoperative
postoperative nausea and vomiting
Time frame: 4 hours postoperative
postoperative nausea and vomiting
Time frame: 24 hours postoperative
Sedation
Time frame: 2 hours postoperative
Sedation
Time frame: 4 hours postoperative
Sedation
Time frame: 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
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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.
Sohair A Megalla, MD principal investigator
Anesthesia and ICU department, Faculty of Medicine, Minia University
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 10 MG/ML and Nalbuphine Hydrochloride 10 MG/ML in people with Pruritus and Pain, Postoperative, run by Minia 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 3 inclusion and 2 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 1 Mar 2021. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sohair A Megalla, MD (+20 120 003 6447, Sohair.Adeeb@minia.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pruritus (time frame: 2 hours postoperatively). The study lists 3 primary outcomes in all. 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 1 Mar 2021.