Postoperative PainNCT03150732
Systemic Nalbuphine Versus Intravenous Regional Anesthesia
A study testing Systemic nalbuphine and Local nalbuphine in people with Postoperative Pain, run by Assiut University at 1 site in Egypt.
Trial summary
Comparison of systemic nalbuphine versus intravenous regional anesthesia in patients undergoing hand surgery. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Systemic nalbuphine and Local nalbuphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2022to 10 Feb 2024
- 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
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients scheduled for elective unilateral hand surgery.
Who cannot join
- Patient refusal.
- Allergy to study medications
- Body mass index > 35 kg/ m2
- Patients with sickle cell or Reynaud diseases
- Patients with a history of psychiatric illness or on chronic opioids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Systemic Nalbuphine Versus Intravenous Regional Anesthesia
Comparison of systemic nalbuphine versus intravenous regional anesthesia in patients undergoing hand surgery.
- Conditions
- Postoperative Pain
- Being tested
- Systemic nalbuphine, Local 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.
Systemic nalbuphineDrug
Patients will receive systemic nalbuphine 10 mg
Local nalbuphineDrug
Patients will receive local nalbuphine 10 mg
| Study group | Role | What they receive |
|---|---|---|
| Systemic nalbuphine group | Active comparator | 53 patients will receive nalbuphine systemically Receives: Drug: Systemic nalbuphine |
| Local nalbuphine group | Active comparator | 53 patients will receive nalbuphine with local intravenous regional anesthesia (IVRA) Receives: Drug: Local nalbuphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of postoperative Analgesia
minutes
Measured: Postoperative 24 hours
Secondary outcomes (3)
Diclofenac analgesic consumption
mg
Measured: Postoperative 24 hours
Cortisol level
Level of cortisone in blood (nmol/L)
Measured: Preoperative and at 4 hours after skin incision
Severity of postoperative Pain
Visual Analogue Scale (VAS)
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start10 Aug 2022
- Primary completion10 Feb 2024
- Study completion10 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Model description
- Two groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Bakri, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03150732
- Sponsor's protocol ID
- 000087273
- Status last verified
- Feb 2024
- First submitted
- 8 May 2017
- Last updated
- 20 Feb 2024
- Results posted
- 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 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Systemic Nalbuphine Versus Intravenous Regional Anesthesia
- ClinicalTrials.gov ID
- NCT03150732
- Acronym / sponsor ID
- 000087273
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 10 Feb 2024 (actual)
- Study completion
- 10 Feb 2024 (actual)
- First posted
- 12 May 2017 (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.
Comparison of systemic nalbuphine versus intravenous regional anesthesia in patients undergoing hand 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
- Model description
- Two groups
| Arm | Type | Receives |
|---|---|---|
| Systemic nalbuphine group | Active comparator | Drug: Systemic nalbuphine53 patients will receive nalbuphine systemically |
| Local nalbuphine group | Active comparator | Drug: Local nalbuphine53 patients will receive nalbuphine with local intravenous regional anesthesia (IVRA) |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients scheduled for elective unilateral hand surgery.
Key exclusion criteria (5 listed)
- Patient refusal.
- Allergy to study medications
- Body mass index > 35 kg/ m2
- Patients with sickle cell or Reynaud diseases
- Patients with a history of psychiatric illness or on chronic opioids
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 |
|---|---|---|
| Systemic nalbuphinePatients will receive systemic nalbuphine 10 mg | Drug | Systemic nalbuphine group |
| Local nalbuphinePatients will receive local nalbuphine 10 mg | Drug | Local nalbuphine group |
Primary outcome
Duration of postoperative Analgesia
Time frame: Postoperative 24 hours
minutes
3 secondary outcomes
Diclofenac analgesic consumption
Time frame: Postoperative 24 hours
Cortisol level
Time frame: Preoperative and at 4 hours after skin incision
Severity of postoperative Pain
Time frame: Postoperative 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 20 Feb 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systemic nalbuphine and Local nalbuphine in people with Postoperative Pain, 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 1 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 20 Feb 2024. 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.
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?
Duration of postoperative Analgesia (time frame: Postoperative 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 20 Feb 2024; AzTrials last refreshed its copy on 3 Nov 2026.