Postoperative PainPhase 2NCT06183073
Caudal Block With Bupivacaine and Dexmedetomidine Versus TAP Block With Bupivacaine Alone for Postoperative Analgesia in Pediatric Undergoing Infraumbical Surgeries
A Phase 2 study testing caudal block, Dexmedetomidine and TAP in people with Postoperative Pain, run by Sohag University at 1 site in Egypt.
Trial summary
Acute pain management for pediatric surgical patients intraoperatively and postoperatively is important for their comfort and psychological impact. Children aged 3-9 years old are included in the study and are divided randomly into two groups (45 children in each): Group D: Caudal block with bupivacaine 0.25% in a… Read more about this study
- Who is it for?
- Ages 3 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- caudal block, Dexmedetomidine and TAP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Apr 2023to 1 Feb 2024
- 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 3 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 3-9 years old
- Physical status I and II class of the American Society of Anesthesiologists (ASA)
- Unilateral elective surgeries below the umbilicus
Who cannot join
- Parents or legal guardian refusal.
- History of developmental delay or mental retardation
- Contraindications to regional anesthesia as known or suspected coagulopathy, a known allergy to any of the study drugs, signs of infection at the site of caudal block.
- Hemodynamic unstable patient.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Fouad Ibrahim Soliman
Sohag, 52514
Fouad I Soliman, MD, 01113815186, fouad_soliman@med.sohag.edu.eg
About this study
Official title: Analgesic Efficacy of Transversus Abdominis Plane Block Versus Caudal Dexmedetomidine in Children Undergoing Abdominal Surgeries
Acute pain management for pediatric surgical patients intraoperatively and postoperatively is important for their comfort and psychological impact. Children aged 3-9 years old are included in the study and are divided randomly into two groups (45 children in each):
Group D: Caudal block with bupivacaine 0.25% in a dose of (1 ml / kg) and dexmedetomidine 1μg/ kg.
Group T: TAP block with bupivacaine 0.25% in a dose of (0.5 ml / kg).
- Conditions
- Postoperative Pain
- Being tested
- caudal block, Dexmedetomidine, TAP, Bupivacain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caudal blockProcedure or surgery
Also called bupivacaine
bupivacaine 0.25% in a dose of (1 ml / kg)
DexmedetomidineDrug
dexmedetomidine 1μg/ kg.
TAPProcedure or surgery
analgesia
BupivacainDrug
bupivacaine 0.25% in a dose of (0.5 ml / kg
| Study group | Role | What they receive |
|---|---|---|
| Caudal block with bupivacaine and dexmedetomidine | Active comparator | Caudal block with bupivacaine 0.25% in a dose of (1 ml / kg) and dexmedetomidine 1μg/ kg. Receives: Procedure: caudal block; Drug: Dexmedetomidine; Drug: Bupivacain |
| TAP block with bupivacaine | Active comparator | TAP block with bupivacaine 0.25% in a dose of (0.5 ml / kg). Receives: Procedure: TAP; Drug: Bupivacain |
What is being measured
The primary outcome is the main question the study is designed to answer.
1st analgesic requirement
Time for first analgesic request (paracetamol intravenously 15 mg/kg) (h)
Measured: 12 hours
Secondary outcomes (6)
Heart rate (HR)
Hemodynamic assessment
Measured: 12 hours
systolic Blood Pressure (BP)
Hemodynamic assessment
Measured: 12 hours
diastolic Blood Pressure (BP)
Hemodynamic assessment
Measured: 12 hours
SpO2 -Hemodynamic assessment
Measured: 12 hours
Total paracetamol consumption
Measured: 12 hours
post operative pain score
post operative pain score upon arrival to recovery room and then 2, 4,6, 8 , and 12 hours after surgery using Faces pain scale-revised.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start2 Apr 2023
- Primary completion14 Jan 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
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 Sohag 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fouad Soliman, Sohag University
- Investigators
- Fouad I Soliman, MD, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183073
- Sponsor's protocol ID
- 2009
- Status last verified
- Dec 2023
- First submitted
- 13 Dec 2023
- Last updated
- 27 Dec 2023
- 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 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Transversus Abdominis Plane Block Versus Caudal Dexmedetomidine in Children Undergoing Abdominal Surgeries
- ClinicalTrials.gov ID
- NCT06183073
- Acronym / sponsor ID
- 2009
- Conditions
- Postoperative Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 2 Apr 2023 (actual)
- Primary completion
- 14 Jan 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 27 Dec 2023 (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.
Acute pain management for pediatric surgical patients intraoperatively and postoperatively is important for their comfort and psychological impact. Children aged 3-9 years old are included in the study and are divided randomly into two groups (45 children in each):
Group D: Caudal block with bupivacaine 0.25% in a dose of (1 ml / kg) and dexmedetomidine 1μg/ kg.
Group T: TAP block with bupivacaine 0.25% in a dose of (0.5 ml / kg).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caudal block with bupivacaine and dexmedetomidine | Active comparator | Procedure: caudal block, Drug: Dexmedetomidine, Drug: BupivacainCaudal block with bupivacaine 0.25% in a dose of (1 ml / kg) and dexmedetomidine 1μg/ kg. |
| TAP block with bupivacaine | Active comparator | Procedure: TAP, Drug: BupivacainTAP block with bupivacaine 0.25% in a dose of (0.5 ml / kg). |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 3-9 years old
- Physical status I and II class of the American Society of Anesthesiologists (ASA)
- Unilateral elective surgeries below the umbilicus
Key exclusion criteria (4 listed)
- Parents or legal guardian refusal.
- History of developmental delay or mental retardation
- Contraindications to regional anesthesia as known or suspected coagulopathy, a known allergy to any of the study drugs, signs of infection at the site of caudal block.
- Hemodynamic unstable patient.
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 blockAlso: bupivacainebupivacaine 0.25% in a dose of (1 ml / kg) | Procedure or surgery | Caudal block with bupivacaine and dexmedetomidine |
| Dexmedetomidinedexmedetomidine 1μg/ kg. | Drug | Caudal block with bupivacaine and dexmedetomidine |
| TAPanalgesia | Procedure or surgery | TAP block with bupivacaine |
| Bupivacainbupivacaine 0.25% in a dose of (0.5 ml / kg | Drug | Caudal block with bupivacaine and dexmedetomidine, TAP block with bupivacaine |
Primary outcome
1st analgesic requirement
Time frame: 12 hours
Time for first analgesic request (paracetamol intravenously 15 mg/kg) (h)
6 secondary outcomes
Heart rate (HR)
Time frame: 12 hours
systolic Blood Pressure (BP)
Time frame: 12 hours
diastolic Blood Pressure (BP)
Time frame: 12 hours
SpO2 -Hemodynamic assessment
Time frame: 12 hours
Total paracetamol consumption
Time frame: 12 hours
post operative pain score
Time frame: 12 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
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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.
Fouad I Soliman, MD principal investigator
Sohag 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 caudal block, Dexmedetomidine and TAP in people with Postoperative Pain, run by Sohag 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: status not confirmed, as of the sponsor's last update on 27 Dec 2023. 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.
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 Fouad I Soliman, MD (01113815186, fouad_soliman@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1st analgesic requirement (time frame: 12 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 27 Dec 2023.