Regional AnesthesiaNCT06948253
Comparing Postoperative Analgesic Techniques for Umbilical Hernia Repair: A Randomized Trial of Ultrasound Guided Caudal, Erector Spinae, and External Oblique Interfascial Plane Blocks
A study testing Erector Spinae Plane Block, Caudal Block Anesthesia and External Oblique Intercostal Plane Block in people with Regional Anesthesia, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the efficacy of ultrasound guided Erector block versus caudal block versus external oblique intercostal plane block perioperatively Read more about this study
- Who is it for?
- Ages 2 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Regional Anesthesia
- What is being tested?
- Erector Spinae Plane Block, Caudal Block Anesthesia and External Oblique Intercostal Plane Block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2025to 10 Sep 2025
- 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 2 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- pediatric patients of both sexes undergoing elective umblical hernia surgeries aged from 2 year to 7 years belonging to ASA I or II.
Who cannot join
- Parents refusal.
- Coagulopathy.
- Allergy to local anesthesia.
- Local infection at the site of injection.
- Neurological anomalies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The aim of this study is to evaluate the efficacy of ultrasound guided Erector block versus caudal block versus external oblique intercostal plane block perioperatively
Read the detailed description
umblical hernia repair surgeries have been performed in the practice of pediatric surgeries, ensuring adequate perioperative analgesia is crucial for perioperative care as pain in pediatric patients can cause functional recuperation and lead to negative behavioral changes and family dissatisfaction. (1) Various studies are made to improve postoperative analgesia and facilitate recovery in pediatric patients.(1) Day-case surgery is defined as the planned day admission of a patient to hospital for a surgical procedure, after which there is subsequent successful and safe discharge back home on the same day in a safe and timely manner instead of spending prolonged periods within the hospital.(2) This has significant implications, including reducing hospital stay, hospital-acquired infection, and healthcare-related costs while also improving patient experience and service efficiency. Surgical, anesthetic, and patient factors should be considered for successful day case surgery.(2) External oblique intercostal plane block (EOIPB) is a novel fascial plane block which aims to provide upper midline and lateral abdominal wall analgesia thereby reducing perioperative opioid consumption , LA is deposited into the fascial plane beneath the external oblique muscle (EOM) and superficial to the sixth rib or external intercostal muscle. It targets anterior and lateral cutaneous branches of the thoracoabdominal nerves from the ventral rami of spinal nerves.(3)
Caudal block is the most frequently performed regional technique for pain management in children undergoing lower abdominal surgeries. Ultrasound guidance has resulted in enhanced reliability and safety profiles for caudal blocks.(4) The erector spinae plane block (ESPB), multiple studies demonstrated its potential as a practical approach for managing postoperative pain in the last decade, involves an ultrasound-guided injection of a relatively large volume of local anesthetic into the fascial plane beneath the erector spinae muscle. (5)
- Conditions
- Regional Anesthesia
- Being tested
- Erector Spinae Plane Block, Caudal Block Anesthesia, External Oblique Intercostal Plane Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockOther
The correct location of the needle tip in the fascial plane deep to the erector spinae muscle will be confirmed by injecting 0.5-1 ml of saline and observing the fluid lifting the erector spinae muscle off the transverse process while avoiding muscle distension (hydro dissection)
Caudal Block AnesthesiaOther
The needle will be advanced at a 20-degree angle with needle tip and length visualization. A pop can be appreciated as the needle passes through the sacrococcygeal ligament.
Once the needle will be confirmed to be in the caudal space on the screen, carefully aspirate to confirm absence of CSF or blood.
External Oblique Intercostal Plane BlockOther
the needle will be advanced until the tip lay in the plane between the external oblique muscle and intercostal muscles between the sixth and seventh ribs
| Study group | Role | What they receive |
|---|---|---|
| Group E | Active comparator | Erector spinae plain block group will receive 0.5 ml/kg of 0.25%bupivacaine bilaterally Receives: Other: External Oblique Intercostal Plane Block |
| Group C | Active comparator | Caudal block group will receive 1 ml/kg of 0.25% bupivacaine. Receives: Other: Caudal Block Anesthesia |
| Group EOI | Active comparator | External oblique intercostal block will recive 0.5 ml/kg 0.25 % bupivacaine bilaterally. Receives: Other: Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome
Faces Legs Activity Cry Consolability tool (FLACC, 0- 10)
Measured: 15 minute after operation , 30 minutes after operation and 4 h after operation
Secondary outcomes (1)
Secondary outcome
First dose of fentanyl as a rescue analgesia in dose of 0.5 μg/kg. Total doses of fentanyl as a rescue analgesia.
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 posted29 Apr 2025
- Study start10 Apr 2025
- Primary completion10 Aug 2025 (estimated)
- Study completion10 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional AnesthesiaStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Zakarea Wfa, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06948253
- Sponsor's protocol ID
- 36264PR1119/3/25
- Status last verified
- Apr 2025
- First submitted
- 17 Apr 2025
- Last updated
- 29 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Postoperative Analgesic Techniques for Umbilical Hernia Repair: A Randomized Trial of Ultrasound Guided Caudal, Erector Spinae, and External Oblique Interfascial Plane Blocks
- ClinicalTrials.gov ID
- NCT06948253
- Acronym / sponsor ID
- 36264PR1119/3/25
- Conditions
- Regional Anesthesia
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 10 Aug 2025 (estimated)
- Study completion
- 10 Sep 2025 (estimated)
- First posted
- 29 Apr 2025 (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.
The aim of this study is to evaluate the efficacy of ultrasound guided Erector block versus caudal block versus external oblique intercostal plane block perioperatively
Detailed description
umblical hernia repair surgeries have been performed in the practice of pediatric surgeries, ensuring adequate perioperative analgesia is crucial for perioperative care as pain in pediatric patients can cause functional recuperation and lead to negative behavioral changes and family dissatisfaction. (1) Various studies are made to improve postoperative analgesia and facilitate recovery in pediatric patients.(1) Day-case surgery is defined as the planned day admission of a patient to hospital for a surgical procedure, after which there is subsequent successful and safe discharge back home on the same day in a safe and timely manner instead of spending prolonged periods within the hospital.(2) This has significant implications, including reducing hospital stay, hospital-acquired infection, and healthcare-related costs while also improving patient experience and service efficiency. Surgical, anesthetic, and patient factors should be considered for successful day case surgery.(2) External oblique intercostal plane block (EOIPB) is a novel fascial plane block which aims to provide upper midline and lateral abdominal wall analgesia thereby reducing perioperative opioid consumption , LA is deposited into the fascial plane beneath the external oblique muscle (EOM) and superficial to the sixth rib or external intercostal muscle. It targets anterior and lateral cutaneous branches of the thoracoabdominal nerves from the ventral rami of spinal nerves.(3)
Caudal block is the most frequently performed regional technique for pain management in children undergoing lower abdominal surgeries. Ultrasound guidance has resulted in enhanced reliability and safety profiles for caudal blocks.(4) The erector spinae plane block (ESPB), multiple studies demonstrated its potential as a practical approach for managing postoperative pain in the last decade, involves an ultrasound-guided injection of a relatively large volume of local anesthetic into the fascial plane beneath the erector spinae muscle. (5)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group E | Active comparator | Other: External Oblique Intercostal Plane BlockErector spinae plain block group will receive 0.5 ml/kg of 0.25%bupivacaine bilaterally |
| Group C | Active comparator | Other: Caudal Block AnesthesiaCaudal block group will receive 1 ml/kg of 0.25% bupivacaine. |
| Group EOI | Active comparator | Other: Erector Spinae Plane BlockExternal oblique intercostal block will recive 0.5 ml/kg 0.25 % bupivacaine bilaterally. |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- pediatric patients of both sexes undergoing elective umblical hernia surgeries aged from 2 year to 7 years belonging to ASA I or II.
Key exclusion criteria (5 listed)
- Parents refusal.
- Coagulopathy.
- Allergy to local anesthesia.
- Local infection at the site of injection.
- Neurological anomalies.
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 |
|---|---|---|
| Erector Spinae Plane BlockThe correct location of the needle tip in the fascial plane deep to the erector spinae muscle will be confirmed by injecting 0.5-1 ml of saline and observing the fluid lifting the erector spinae muscle off the transverse process while avoiding muscle distension (hydro dissection) | Other | Group EOI |
| Caudal Block AnesthesiaThe needle will be advanced at a 20-degree angle with needle tip and length visualization. A pop can be appreciated as the needle passes through the sacrococcygeal ligament. Once the needle will be confirmed to be in the caudal space on the screen, carefully aspirate to confirm absence of CSF or blood. | Other | Group C |
| External Oblique Intercostal Plane Blockthe needle will be advanced until the tip lay in the plane between the external oblique muscle and intercostal muscles between the sixth and seventh ribs | Other | Group E |
Primary outcome
Primary outcome
Time frame: 15 minute after operation , 30 minutes after operation and 4 h after operation
Faces Legs Activity Cry Consolability tool (FLACC, 0- 10)
1 secondary outcome
Secondary outcome
Time frame: 6 hours
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 29 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
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 Erector Spinae Plane Block, Caudal Block Anesthesia and External Oblique Intercostal Plane Block in people with Regional Anesthesia, run by Tanta 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: enrolling by invitation, as of the sponsor's last update on 29 Apr 2025. 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?
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?
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?
Primary outcome (time frame: 15 minute after operation , 30 minutes after operation and 4 h after operation). 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 29 Apr 2025; AzTrials last refreshed its copy on 30 Oct 2026.