We Are Studying the Effects of Caudal Dexamethasone in Neonates Undergoing Inguinal Hernia RepairNCT07609836
Caudal Dexamethasone - Bupivacaine in Neonates
A study testing We add Dexamethasone to Bupivacaine as adjuvant to Bupivacaine in neonsates undergoing inguinal hernia repair in Dexamethasone - Bupivacaine group in people with We Are Studying the Effects of Caudal Dexamethasone in Neonates Undergoing Inguinal Hernia Repair, run by Ain Shams University.
Trial summary
Randomied controlled study Evaluate the effects of caudal Dexamethasone in neonates Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- We Are Studying the Effects of Caudal Dexamethasone in Neonates Undergoing Inguinal Hernia Repair
- What is being tested?
- We add Dexamethasone to Bupivacaine as adjuvant to Bupivacaine in neonsates undergoing inguinal hernia repair in Dexamethasone - Bupivacaine group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 day to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- full term neonate
- ASA I \& ASA II
- Scheduled for inguinal hernia repair
Who cannot join
- Patients with allergies to studied drugs
- body weight <3 kilograms
- parents refusal
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Sawsan Haridy Ahmed Abu El Hassan, Lecturer of anesthesia contact
About this study
Official title: Analgesic Efficacy Of Dexamethasone As Adjuvant To Caudal Bupivacaine For Neonates Undergoing Inguinal Hernia Repair: Randomized Controlled Study
Randomied controlled study Evaluate the effects of caudal Dexamethasone in neonates
Read the detailed description
Evaluate the additive analgesic effects of caudal Dexamethasone in neonates undergoing inguinal hernia repair.
additive side effects if found
- Conditions
- We Are Studying the Effects of Caudal Dexamethasone in Neonates Undergoing Inguinal Hernia Repair
- Being tested
- We add Dexamethasone to Bupivacaine as adjuvant to Bupivacaine in neonsates undergoing inguinal hernia repair in Dexamethasone - Bupivacaine group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
We add Dexamethasone to Bupivacaine as adjuvant to Bupivacaine in neonsates undergoing inguinal hernia repair in Dexamethasone - Bupivacaine groupProcedure or surgery
We add Dexamethasone to Bupivacaine as adjuvant to Bupivacaine in neonates undergoing inguinal hernia repair
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone - Bupivacaine group | Active comparator | Add Dexamethasone to Bupivacaine in caudal anesthesia in neonate Receives: Procedure: We add Dexamethasone to Bupivacaine as adjuvant to Bupivacaine in neonsates undergoing inguinal hernia repair in Dexamethasone - Bupivacaine group |
| Saline - Bupivacaine group | Other | Control group to the other arm of the study Receives: Procedure: We add Dexamethasone to Bupivacaine as adjuvant to Bupivacaine in neonsates undergoing inguinal hernia repair in Dexamethasone - Bupivacaine group |
What is being measured
The primary outcome is the main question the study is designed to answer.
FLACC pain scale (face,leg , activity,cry, consolability) in the first 24 hours postoperative
Assessment for additive analgesic effects of caudal Dexamethasone
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study startMay 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for We Are Studying the Effects of Caudal Dexamethasone in Neonates Undergoing Inguinal Hernia RepairStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sawsan haridy ahmed aboelhassan, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07609836
- Sponsor's protocol ID
- O6U-ERC-0136
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy Of Dexamethasone As Adjuvant To Caudal Bupivacaine For Neonates Undergoing Inguinal Hernia Repair: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07609836
- Acronym / sponsor ID
- O6U-ERC-0136
- Conditions
- We Are Studying the Effects of Caudal Dexamethasone in Neonates Undergoing Inguinal Hernia Repair
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 May 2026 (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.
Randomied controlled study Evaluate the effects of caudal Dexamethasone in neonates
Detailed description
Evaluate the additive analgesic effects of caudal Dexamethasone in neonates undergoing inguinal hernia repair.
additive side effects if found
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone - Bupivacaine group | Active comparator | Procedure: We add Dexamethasone to Bupivacaine as adjuvant to Bupivacaine in neonsates undergoing inguinal hernia repair in Dexamethasone - Bupivacaine groupAdd Dexamethasone to Bupivacaine in caudal anesthesia in neonate |
| Saline - Bupivacaine group | Other | Procedure: We add Dexamethasone to Bupivacaine as adjuvant to Bupivacaine in neonsates undergoing inguinal hernia repair in Dexamethasone - Bupivacaine groupControl group to the other arm of the study |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- full term neonate
- ASA I \& ASA II
- Scheduled for inguinal hernia repair
Key exclusion criteria (3 listed)
- Patients with allergies to studied drugs
- body weight <3 kilograms
- parents refusal
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 |
|---|---|---|
| We add Dexamethasone to Bupivacaine as adjuvant to Bupivacaine in neonsates undergoing inguinal hernia repair in Dexamethasone - Bupivacaine groupWe add Dexamethasone to Bupivacaine as adjuvant to Bupivacaine in neonates undergoing inguinal hernia repair | Procedure or surgery | Dexamethasone - Bupivacaine group, Saline - Bupivacaine group |
Primary outcome
FLACC pain scale (face,leg , activity,cry, consolability) in the first 24 hours postoperative
Time frame: 6 months
Assessment for additive analgesic effects of caudal Dexamethasone
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No
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.
Sawsan Haridy Ahmed Abu El Hassan, Lecturer of anesthesia contact
Questions about this trial
What is this clinical trial studying?
A study testing We add Dexamethasone to Bupivacaine as adjuvant to Bupivacaine in neonsates undergoing inguinal hernia repair in Dexamethasone - Bupivacaine group in people with We Are Studying the Effects of Caudal Dexamethasone in Neonates Undergoing Inguinal Hernia Repair, run by Ain Shams University.
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: opening soon, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sawsan Haridy Ahmed Abu El Hassan, Lecturer of anesthesia (002- 01228118341, sawsan_haridy@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FLACC pain scale (face,leg , activity,cry, consolability) in the first 24 hours postoperative (time frame: 6 months). 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 27 May 2026.