Post Operative Analgesia in Children Undergoing Infraumblical SurgeriesPhase 1NCT05117021
Comparative Study Between Caudal Epidural Block and Ultrasound Guided Transversus Abdominis Plane Block for Post Operative Analgesia in Children Undergoing Infraumblical Surgeries
A Phase 1 study testing Caudal Epidural Block using 0.25% plain bupivacaine dose 1 ml / kg and Ultrasound Guided Transversus Abdominis Plane Block using 0.25% plain bupivacaine dose 0.5 ml / kg in people with Post Operative Analgesia in Children Undergoing Infraumblical Surgeries, run by Sohag University at 1 site in Egypt.
Trial summary
Comparative study between Caudal Epidural Block and Ultrasound Guided Transversus Abdominis Plane Block for post operative analgesia Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Post Operative Analgesia in Children Undergoing Infraumblical Surgeries
- What is being tested?
- Caudal Epidural Block using 0.25% plain bupivacaine dose 1 ml / kg and Ultrasound Guided Transversus Abdominis Plane Block using 0.25% plain bupivacaine dose 0.5 ml / kg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2021to Apr 2022
- Phase
- Phase 1
- 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 4 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 120 children, aged between 4 and 7 years undergoing infraumblical surgeries as ( hypospadias , inguinal hernia and orchopexy ).patients will be selected according to ASA physical status class I to II from both genders who be able to swallow tablets.
Who cannot join
- parents' refusal.
- urgent cases.
- other contraindications of regional anesthesia (e.g. infection at injection site, coagulopathy and allergy to bupivacaine)
- Insulin dependent diabetes
- Thyroid disease
Trial locations and contacts
1 site in 1 country.
hala m hashem, assistant professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
Osama R ELsheref, professor
About this study
Comparative study between Caudal Epidural Block and Ultrasound Guided Transversus Abdominis Plane Block for post operative analgesia
Read the detailed description
Comparative study between Caudal Epidural Block and Ultrasound Guided Transversus Abdominis Plane Block for post operative analgesia in children undergoing infraumblical surgeries
- Being tested
- Caudal Epidural Block using 0.25% plain bupivacaine dose 1 ml / kg and Ultrasound Guided Transversus Abdominis Plane Block using 0.25% plain bupivacaine dose 0.5 ml / kg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caudal Epidural Block using 0.25% plain bupivacaine dose 1 ml / kg and Ultrasound Guided Transversus Abdominis Plane Block using 0.25% plain bupivacaine dose 0.5 ml / kgDrug
Caudal Epidural Block and Ultrasound Guided Transversus Abdominis Plane Block using 0.25% plain bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Group of Bupivacaine injection in Caudal block group | Experimental | The children will receive of 0.25% plain bupivacaine infiltration as caudal block for post operative analgesia in infraumblical surgeries Receives: Drug: Caudal Epidural Block using 0.25% plain bupivacaine dose 1 ml / kg and Ultrasound Guided Transversus Abdominis Plane Block using 0.25% plain bupivacaine dose 0.5 ml / kg |
| Group 2 : Group of Bupivacaine injection in TAP block group | Experimental | The children will receive of 0.25% plain bupivacaine infiltration as Transversus Abdominis Plane Block for post operative analgesia in infraumblical surgeries Receives: Drug: Caudal Epidural Block using 0.25% plain bupivacaine dose 1 ml / kg and Ultrasound Guided Transversus Abdominis Plane Block using 0.25% plain bupivacaine dose 0.5 ml / kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative analgesia in infraumblicial surgeries in children children undergoing infraumblical surgeries
Comparative study between Caudal Epidural Block and Ultrasound Guided Transversus Abdominis Plane Block for post operative analgesia in children undergoing infraumblical surgeries.
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 posted11 Nov 2021
- Study startNov 2021 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post Operative Analgesia in Children Undergoing Infraumblical SurgeriesStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haitham Mohamed Ismail, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117021
- Sponsor's protocol ID
- Soh-Med-21-10-40
- Status last verified
- Nov 2021
- First submitted
- 17 Oct 2021
- Last updated
- 11 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Wang L, Xiao Y, Tian T, Jin L, Lei Y, Finnell RH, Ren A. Corrigendum to "Digenic variants of planar cell polarity genes in human neural tube defect patients." Mol Genet Metab. 2018 May;124(1):94-100. doi:10.1016/j.ymgme.2018.03.005. Epub 2018 Mar 18. https://pubmed.ncbi.nlm.nih.gov/29573971/. Mol Genet Metab. 2021 Mar;132(3):211. doi: 10.1016/j.ymgme.2021.01.010. Epub 2021 Feb 10. No abstract available.
PubMed 33582009Kumar A, Dogra N, Gupta A, Aggarwal S. Ultrasound-guided transversus abdominis plane block versus caudal block for postoperative analgesia in children undergoing inguinal hernia surgery: A comparative study. J Anaesthesiol Clin Pharmacol. 2020 Apr-Jun;36(2):172-176. doi: 10.4103/joacp.JOACP_100_19. Epub 2020 Jun 15.
PubMed 33013030Willschke H, Kettner S. Pediatric regional anesthesia: abdominal wall blocks. Paediatr Anaesth. 2012 Jan;22(1):88-92. doi: 10.1111/j.1460-9592.2011.03704.x. Epub 2011 Nov 14.
PubMed 22077146
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Caudal Epidural Block and Ultrasound Guided Transversus Abdominis Plane Block for Post Operative Analgesia in Children Undergoing Infraumblical Surgeries
- ClinicalTrials.gov ID
- NCT05117021
- Acronym / sponsor ID
- Soh-Med-21-10-40
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 11 Nov 2021 (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.
Comparative study between Caudal Epidural Block and Ultrasound Guided Transversus Abdominis Plane Block for post operative analgesia
Detailed description
Comparative study between Caudal Epidural Block and Ultrasound Guided Transversus Abdominis Plane Block for post operative analgesia in children undergoing infraumblical surgeries
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group of Bupivacaine injection in Caudal block group | Experimental | Drug: Caudal Epidural Block using 0.25% plain bupivacaine dose 1 ml / kg and Ultrasound Guided Transversus Abdominis Plane Block using 0.25% plain bupivacaine dose 0.5 ml / kgThe children will receive of 0.25% plain bupivacaine infiltration as caudal block for post operative analgesia in infraumblical surgeries |
| Group 2 : Group of Bupivacaine injection in TAP block group | Experimental | Drug: Caudal Epidural Block using 0.25% plain bupivacaine dose 1 ml / kg and Ultrasound Guided Transversus Abdominis Plane Block using 0.25% plain bupivacaine dose 0.5 ml / kgThe children will receive of 0.25% plain bupivacaine infiltration as Transversus Abdominis Plane Block for post operative analgesia in infraumblical surgeries |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 120 children, aged between 4 and 7 years undergoing infraumblical surgeries as ( hypospadias , inguinal hernia and orchopexy ).patients will be selected according to ASA physical status class I to II from both genders who be able to swallow tablets.
Key exclusion criteria (5 listed)
- parents' refusal.
- urgent cases.
- other contraindications of regional anesthesia (e.g. infection at injection site, coagulopathy and allergy to bupivacaine)
- Insulin dependent diabetes
- Thyroid disease
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 Epidural Block using 0.25% plain bupivacaine dose 1 ml / kg and Ultrasound Guided Transversus Abdominis Plane Block using 0.25% plain bupivacaine dose 0.5 ml / kgCaudal Epidural Block and Ultrasound Guided Transversus Abdominis Plane Block using 0.25% plain bupivacaine | Drug | Group 2 : Group of Bupivacaine injection in TAP block group, Group of Bupivacaine injection in Caudal block group |
Primary outcome
post operative analgesia in infraumblicial surgeries in children children undergoing infraumblical surgeries
Time frame: 6 months
Comparative study between Caudal Epidural Block and Ultrasound Guided Transversus Abdominis Plane Block for post operative analgesia in children undergoing infraumblical surgeries.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Background: PubMed 33582009Wang L, Xiao Y, Tian T, Jin L, Lei Y, Finnell RH, Ren A. Corrigendum to "Digenic variants of planar cell polarity genes in human neural tube defect patients." Mol Genet Metab. 2018 May;124(1):94-100. doi:10.1016/j.ymgme.2018.03.005. Epub 2018 Mar 18. https://pubmed.ncbi.nlm.nih.gov/29573971/. Mol Genet Metab. 2021 Mar;132(3):211. doi: 10.1016/j.ymgme.2021.01.010. Epub 2021 Feb 10. No abstract available.
- Background: PubMed 33013030Kumar A, Dogra N, Gupta A, Aggarwal S. Ultrasound-guided transversus abdominis plane block versus caudal block for postoperative analgesia in children undergoing inguinal hernia surgery: A comparative study. J Anaesthesiol Clin Pharmacol. 2020 Apr-Jun;36(2):172-176. doi: 10.4103/joacp.JOACP_100_19. Epub 2020 Jun 15.
- Background: PubMed 22077146Willschke H, Kettner S. Pediatric regional anesthesia: abdominal wall blocks. Paediatr Anaesth. 2012 Jan;22(1):88-92. doi: 10.1111/j.1460-9592.2011.03704.x. Epub 2011 Nov 14.
- Individual participant dataSharing planned: Yes
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.
hala m hashem, assistant professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Caudal Epidural Block using 0.25% plain bupivacaine dose 1 ml / kg and Ultrasound Guided Transversus Abdominis Plane Block using 0.25% plain bupivacaine dose 0.5 ml / kg in people with Post Operative Analgesia in Children Undergoing Infraumblical Surgeries, 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 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: status not confirmed, as of the sponsor's last update on 11 Nov 2021. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 haitham m esmail, resident doctor (01119775104, hitham0112245@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post operative analgesia in infraumblicial surgeries in children children undergoing infraumblical surgeries (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05117021, which also lists 3 linked publications.
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 11 Nov 2021.