Postoperative PainNCT02618876
Effect of Caudal Nalbuphine on Postoperative Analgesia in Children
A study testing Nalbuphine plus Bupivacaine and Bupivacaine in people with Postoperative Pain, run by Assiut University at 1 site in Egypt.
Trial summary
Nalbuphine as an adjuvant to bupivacaine caudal anesthesia for postoperative analgesia in children undergoing Hypospadias repair. 2 groups, 30 patients each Read more about this study
- Who is it for?
- Ages 2 to 10 years, men only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Nalbuphine plus Bupivacaine and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2015to Dec 2019
- 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 2 to 10 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Children undergoing elective Hypospadias repair
- with American Society of Anesthesiologists (ASA) physical status I
- age 2-10 years
Who cannot join
- Coagulation disorder
- allergy to study medications
- major malformations of the lower spine or meninges or any cutaneous or subcutaneous lesion at the site of injection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nalbuphine as an Adjuvant to Caudal Bupivacaine for Postoperative Analgesia in Children Undergoing Hypospadias Repair
Nalbuphine as an adjuvant to bupivacaine caudal anesthesia for postoperative analgesia in children undergoing Hypospadias repair.
2 groups, 30 patients each
- Conditions
- Postoperative Pain
- Being tested
- Nalbuphine plus Bupivacaine, Bupivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nalbuphine plus BupivacaineDrug
Addition of caudal Nalbuphine to the standard Bupivacaine
BupivacaineDrug
Caudal Bupivacaine is the standard of care will be considered as a control
| Study group | Role | What they receive |
|---|---|---|
| Nalbuphine group | Active comparator | 30 children will be given Caudal Bupivacaine plus Nalbuphine. Receives: Drug: Nalbuphine plus Bupivacaine |
| Control group | Other | 30 children will be given Caudal Bupivacaine. Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity Measured by Face, Legs, Activity, Cry & consolability (FLACC) pain scale
Measured: During 24 h in the postoperative period
Secondary outcomes (1)
Cortisol level
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2019
- Study completionDec 2019
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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 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
- NCT02618876
- Sponsor's protocol ID
- IRB 000087145
- Status last verified
- Apr 2020
- First submitted
- 25 Nov 2015
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nalbuphine as an Adjuvant to Caudal Bupivacaine for Postoperative Analgesia in Children Undergoing Hypospadias Repair
- ClinicalTrials.gov ID
- NCT02618876
- Acronym / sponsor ID
- IRB 000087145
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 2 Dec 2015 (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.
Nalbuphine as an adjuvant to bupivacaine caudal anesthesia for postoperative analgesia in children undergoing Hypospadias repair.
2 groups, 30 patients each
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 |
|---|---|---|
| Nalbuphine group | Active comparator | Drug: Nalbuphine plus Bupivacaine30 children will be given Caudal Bupivacaine plus Nalbuphine. |
| Control group | Other | Drug: Bupivacaine30 children will be given Caudal Bupivacaine. |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children undergoing elective Hypospadias repair
- with American Society of Anesthesiologists (ASA) physical status I
- age 2-10 years
Key exclusion criteria (3 listed)
- Coagulation disorder
- allergy to study medications
- major malformations of the lower spine or meninges or any cutaneous or subcutaneous lesion at the site of 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 |
|---|---|---|
| Nalbuphine plus BupivacaineAddition of caudal Nalbuphine to the standard Bupivacaine | Drug | Nalbuphine group |
| BupivacaineCaudal Bupivacaine is the standard of care will be considered as a control | Drug | Control group |
Primary outcome
Postoperative pain intensity Measured by Face, Legs, Activity, Cry & consolability (FLACC) pain scale
Time frame: During 24 h in the postoperative period
1 secondary outcome
Cortisol level
Time frame: 6 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 7 Apr 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.
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 Nalbuphine plus Bupivacaine and Bupivacaine 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 3 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 7 Apr 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. 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?
Postoperative pain intensity Measured by Face, Legs, Activity, Cry & consolability (FLACC) pain scale (time frame: During 24 h in the postoperative period). 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 7 Apr 2020.