AnesthesiaNCT07127601
Comparative Study Between US Guided Erector Spinae and US Guided Cudal Epidural Block
A study testing Ultrasound guided erector spinae plain block (ESPB). in people with Anesthesia and Hernia, Inguinal, run by Ain Shams University at 1 site in Egypt.
Trial summary
Inguinal hernia is a common condition requiring surgical repair in the pediatric age group. The incidence of inguinal hernias is approximately 3% to 5% in term infants and 13% in infants born at less than 33 weeks of gestational age. Read more about this study
- Who is it for?
- Ages 3 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Hernia, Inguinal
- What is being tested?
- Ultrasound guided erector spinae plain block (ESPB).
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Dec 2023
- 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 3 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age 3 moonths 6 years old
- American Society of Anesthesiologists physical status I, II for non complicated inguinal hernia.
Who cannot join
- Patients with a sepsis
- malignancy anywhere
- patient with bleeding tendencies or on anticoagulation therapy,
- allergy to study drugs
- congenital anomalies
- delayed motor or developmental milestones
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between US Guided Erector Spinae and US Guided Cudal Epidural Block in Paediatric Unilateral Inguinal Hernia Repair Adjuvant to General Anaesthesia
Inguinal hernia is a common condition requiring surgical repair in the pediatric age group. The incidence of inguinal hernias is approximately 3% to 5% in term infants and 13% in infants born at less than 33 weeks of gestational age. Inguinal hernias in both term and preterm infants are commonly repaired shortly after diagnosis to avoid incarceration of the hernia. Given the lack of definitive data, optimal timing for repair of inguinal hernias in infants remains debatable[1].
: An erector spinae plane block is a relatively new regional anesthetic technique. Apart from case reports and small series, the literature regarding pediatric use is limited.
Read more
The first author to describe caudal anaesthesia as applied to children (here in connection with urologic surgical procedures) was Meredith Campbell in 1933.(2) Over time, this idea has developed into a technique of great interest, especially for use in premature infants and in newborns, considering that these paediatric subgroups are, as a result of an immature state of the CNS, at high risk of perioperative respiratory depression.
This study will be conducted to compare caudal versus ESPB as regard intraoperative and postoperative analgesia in unilateral inguinal hernia and the feasibility of ESPB in paediatric patient.
- Conditions
- Anesthesia, Hernia, Inguinal
- Being tested
- Ultrasound guided erector spinae plain block (ESPB).
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided erector spinae plain block (ESPB).Procedure or surgery
Depending on the size of patient, either a 27 g 3 cm hypodermic needle or a 21 g 5 or 10 cm short bevel needle was used. All blocks were performed with the ultrasound guidance in the parasagittal position and with continuous in-plane needle visualization. The local anesthetic was deposited in the fascial plane deep to the erector spinae muscle superficial to the transverse processes, after confirming the correct tissue plane by hydro-dissection. protocols for choosing 0.25% bupivacaine with a dose of 0.5ml/kg was determined by the age and weight of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided erector spinae plain block (ESPB). | Experimental | Not described Receives: Procedure: Ultrasound guided erector spinae plain block (ESPB). |
| caudal analgesia (anatomically)with lumber level of anagesia | Active comparator | Not described Receives: Procedure: Ultrasound guided erector spinae plain block (ESPB). |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate response to skin incision
count of heart beats per minute
Measured: basal before surgery, after 5 minutes intra-operative, 10 minutes intra-operative, 15 minutes intra-operative
Secondary outcomes (1)
pain scores
FLACC score at recovery FLACC score at recovery FLAAC score
Measured: at recovery, 30 minutes postoperative, 1 hour postoperative, 3 hours postoperative, 6 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start1 Jan 2023
- Primary completion1 Sep 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Noser, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127601
- Sponsor's protocol ID
- R 14 2022
- Status last verified
- Jun 2024
- First submitted
- 14 Jun 2024
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between US Guided Erector Spinae and US Guided Cudal Epidural Block in Paediatric Unilateral Inguinal Hernia Repair Adjuvant to General Anaesthesia
- ClinicalTrials.gov ID
- NCT07127601
- Acronym / sponsor ID
- R 14 2022
- Conditions
- Anesthesia, Hernia, Inguinal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 17 Aug 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.
Inguinal hernia is a common condition requiring surgical repair in the pediatric age group. The incidence of inguinal hernias is approximately 3% to 5% in term infants and 13% in infants born at less than 33 weeks of gestational age. Inguinal hernias in both term and preterm infants are commonly repaired shortly after diagnosis to avoid incarceration of the hernia. Given the lack of definitive data, optimal timing for repair of inguinal hernias in infants remains debatable[1].
: An erector spinae plane block is a relatively new regional anesthetic technique. Apart from case reports and small series, the literature regarding pediatric use is limited.
The first author to describe caudal anaesthesia as applied to children (here in connection with urologic surgical procedures) was Meredith Campbell in 1933.(2) Over time, this idea has developed into a technique of great interest, especially for use in premature infants and in newborns, considering that these paediatric subgroups are, as a result of an immature state of the CNS, at high risk of perioperative respiratory depression.
This study will be conducted to compare caudal versus ESPB as regard intraoperative and postoperative analgesia in unilateral inguinal hernia and the feasibility of ESPB in paediatric patient.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided erector spinae plain block (ESPB). | Experimental | Procedure: Ultrasound guided erector spinae plain block (ESPB). |
| caudal analgesia (anatomically)with lumber level of anagesia | Active comparator | Procedure: Ultrasound guided erector spinae plain block (ESPB). |
Who may qualify
- Ages
- 3 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- age 3 moonths 6 years old
- American Society of Anesthesiologists physical status I, II for non complicated inguinal hernia.
Key exclusion criteria (6 listed)
- Patients with a sepsis
- malignancy anywhere
- patient with bleeding tendencies or on anticoagulation therapy,
- allergy to study drugs
- congenital 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 |
|---|---|---|
| Ultrasound guided erector spinae plain block (ESPB).Depending on the size of patient, either a 27 g 3 cm hypodermic needle or a 21 g 5 or 10 cm short bevel needle was used. All blocks were performed with the ultrasound guidance in the parasagittal position and with continuous in-plane needle visualization. The local anesthetic was deposited in the fascial plane deep to the erector spinae muscle superficial to the transverse processes, after confirming the correct tissue plane by hydro-dissection. protocols for choosing 0.25% bupivacaine with a dose of 0.5ml/kg was determined by the age and weight of the patient. | Procedure or surgery | Ultrasound guided erector spinae plain block (ESPB)., caudal analgesia (anatomically)with lumber level of anagesia |
Primary outcome
heart rate response to skin incision
Time frame: basal before surgery, after 5 minutes intra-operative, 10 minutes intra-operative, 15 minutes intra-operative
count of heart beats per minute
1 secondary outcome
pain scores
Time frame: at recovery, 30 minutes postoperative, 1 hour postoperative, 3 hours postoperative, 6 hours postoperative
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 17 Aug 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. 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 Ultrasound guided erector spinae plain block (ESPB). in people with Anesthesia and Hernia, Inguinal, 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 2 inclusion and 6 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 17 Aug 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?
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?
heart rate response to skin incision (time frame: basal before surgery, after 5 minutes intra-operative, 10 minutes intra-operative, 15 minutes intra-operative). 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 17 Aug 2025.