Caudal AnesthesiaNCT05617976
Nalbuphine as an Adjuvant to Levobupivacaine in Caudal Analgesia in Children
A study testing caudal block in people with Caudal Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
Caudal anesthesia is the single most important pediatric regional anesthetic technique and is increasingly performed in pediatric regional anesthesia practices. It is preferred in order to relieve intra-operative and postoperative pain in children of all age groups undergoing pelvi-abdominal or lower limbs surgeries… Read more about this study
- Who is it for?
- Ages 1 year to 3 years
- Conditions the study is for
- Caudal Anesthesia
- What is being tested?
- caudal block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Oct 2020to 20 Sep 2021
- 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 1 year to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA I, II.
- Age 1-3 years.
- Patients scheduled for hypospadias repair surgeries.
Who cannot join
- ASA III, IV.
- Signs of infection at site of injection.
- Known coagulopathy disorder.
- Mental and / or developmental retardation.
Trial locations and contacts
1 site in 1 country.
About this study
Caudal anesthesia is the single most important pediatric regional anesthetic technique and is increasingly performed in pediatric regional anesthesia practices. It is preferred in order to relieve intra-operative and postoperative pain in children of all age groups undergoing pelvi-abdominal or lower limbs surgeries using levobupivacaine 0.25%.Various adjuvants have been added to levobupivacaine to prolong postoperative caudal analgesia. Nalbuphine as many opioids can be added in caudal analgesia. This prospective randomized double blind study was done to compare the effects of plain levobupivacaine versus Levobupivacaine plus nalbuphine single-shot for postoperative pain relief in children undergoing hypospadius repair surgery.
- Conditions
- Caudal Anesthesia
- Being tested
- caudal block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caudal blockProcedure or surgery
caudal block
| Study group | Role | What they receive |
|---|---|---|
| Group L (levobupivacaine only group) | Active comparator | Caudal block was done in this group using levobupivacaine 0.25% with the dose of 1 ml /kg plus one ml normal saline after induction of general anesthesia. Receives: Procedure: caudal block |
| Group L+N(levobupivacaine plus nalbuphen group) | Active comparator | Caudal block was done in this group using levobupivacaine 0.25% with the dose of 1 ml /kg and nalbuphine 0.1 mg /kg in one ml normal saline after induction of general anesthesia. Receives: Procedure: caudal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Postoperative analgesia
Face legs activity cry consolablity score (FLACC) (0-10) Score: 0, no pain; 1-3, mild pain; 4-7, moderate pain; 8-10, severe pain
Measured: 24 hours
duration of analgesia
Time to first analgesia request (TFAR)
Measured: 24hours
Secondary outcomes (1)
analgesic consumption
total dose of rescue analgesic
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 posted16 Nov 2022
- Study start4 Oct 2020
- Primary completion20 Sep 2021
- Study completion20 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caudal AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05617976
- Sponsor's protocol ID
- FMASU MS 120/2020
- Status last verified
- Nov 2022
- First submitted
- 23 Feb 2022
- Last updated
- 16 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nalbuphine as an Adjuvant to Levobupivacaine in Caudal Analgesia in Children
- ClinicalTrials.gov ID
- NCT05617976
- Acronym / sponsor ID
- FMASU MS 120/2020
- Conditions
- Caudal Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 4 Oct 2020 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 16 Nov 2022 (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.
Caudal anesthesia is the single most important pediatric regional anesthetic technique and is increasingly performed in pediatric regional anesthesia practices. It is preferred in order to relieve intra-operative and postoperative pain in children of all age groups undergoing pelvi-abdominal or lower limbs surgeries using levobupivacaine 0.25%.Various adjuvants have been added to levobupivacaine to prolong postoperative caudal analgesia. Nalbuphine as many opioids can be added in caudal analgesia. This prospective randomized double blind study was done to compare the effects of plain levobupivacaine versus Levobupivacaine plus nalbuphine single-shot for postoperative pain relief in children undergoing hypospadius repair surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group L (levobupivacaine only group) | Active comparator | Procedure: caudal blockCaudal block was done in this group using levobupivacaine 0.25% with the dose of 1 ml /kg plus one ml normal saline after induction of general anesthesia. |
| Group L+N(levobupivacaine plus nalbuphen group) | Active comparator | Procedure: caudal blockCaudal block was done in this group using levobupivacaine 0.25% with the dose of 1 ml /kg and nalbuphine 0.1 mg /kg in one ml normal saline after induction of general anesthesia. |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA I, II.
- Age 1-3 years.
- Patients scheduled for hypospadias repair surgeries.
Key exclusion criteria (4 listed)
- ASA III, IV.
- Signs of infection at site of injection.
- Known coagulopathy disorder.
- Mental and / or developmental retardation.
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 |
|---|---|---|
| caudal blockcaudal block | Procedure or surgery | Group L (levobupivacaine only group), Group L+N(levobupivacaine plus nalbuphen group) |
Primary outcome
Quality of Postoperative analgesia
Time frame: 24 hours
Face legs activity cry consolablity score (FLACC) (0-10) Score: 0, no pain; 1-3, mild pain; 4-7, moderate pain; 8-10, severe pain
duration of analgesia
Time frame: 24hours
Time to first analgesia request (TFAR)
1 secondary outcome
analgesic consumption
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 16 Nov 2022.
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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 caudal block in people with Caudal Anesthesia, run by Ain Shams 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 4 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 16 Nov 2022. 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?
Quality of Postoperative analgesia (time frame: 24 hours). The study lists 2 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 16 Nov 2022.