UltrasoundNCT06725667
Ultrasound-Guided Transversalis Fascia Plane Block Versus Caudal Block for Postoperative Analgesia in Children Undergoing Inguinal Herniorrhaphy
A study testing Transversalis fascia plane block and Caudal block in people with Ultrasound and Transversalis Fascia Plane Block, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to compare ultrasound-guided transversalis fascia plane block and caudal block for postoperative analgesia in children undergoing inguinal herniorrhaphy. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Ultrasound, Transversalis Fascia Plane Block, Caudal Block
- What is being tested?
- Transversalis fascia plane block and Caudal block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Dec 2024to 6 Dec 2025
- 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 1 year to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age from 1 to 7 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-II.
- Scheduled for inguinal herniorrhaphy under general anesthesia (GA).
Who cannot join
- Repeated surgeries.
- Known allergic reactions to any of the study's drugs.
- Infection at the site of block needle entry.
- Bleeding diathesis.
- Neurological disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-Guided Transversalis Fascia Plane Block Versus Caudal Block for Postoperative Analgesia in Children Undergoing Inguinal Herniorrhaphy: A Randomized Controlled Non-Inferiority Trial
The aim of this study is to compare ultrasound-guided transversalis fascia plane block and caudal block for postoperative analgesia in children undergoing inguinal herniorrhaphy.
Read the detailed description
Surgical repair of inguinal hernia is one of the most common day-case surgeries in the pediatric population. It is associated with significant postoperative pain and discomfort.
Caudal block analgesia is a popular and reliable technique for lower abdominal surgeries and found to be safe and effective for providing intra and postoperative analgesia in pediatric patients.
transversal fascia plane block (TFPB) aims to provide analgesia for invasive procedures of the inguinal and sublingual areas by blocking the subcostal (T12), ilioinguinal (L1) and iliohypogastric (T12-L1) nerves. Several studies have reported TFPB as the analgesic method of choice for procedures involving the T12-L1 dermatome region, including iliac bone graft harvesting, cesarean section, and inguinal hernia repair
- Conditions
- Ultrasound, Transversalis Fascia Plane Block, Caudal Block, Postoperative Analgesia, Children, Inguinal Herniorrhaphy
- Being tested
- Transversalis fascia plane block, Caudal block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversalis fascia plane blockOther
Patients will receive transversalis fascia plane block after the induction of general anesthesia.
Caudal blockOther
Patients will receive caudal block after the induction of general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Transversalis fascia plane block group | Experimental | Patients will receive transversalis fascia plane block after the induction of general anesthesia. Receives: Other: Transversalis fascia plane block |
| Caudal block group | Active comparator | Patients will receive caudal block after the induction of general anesthesia. Receives: Other: Caudal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the 1st rescue analgesia
Time to the first request for the rescue analgesia (time from the end of surgery to first dose of paracetamol administrated).
Measured: 24 hours postoperatively
Secondary outcomes (7)
Total paracetamol consumption
Each of the five items of the Face, legs, activity, cry, and consolability (FLACC) scale will be scared, ranging from 0 to 2, which will be then aggregated to obtain a total score ranging from 0 to 10. Higher scores on the scale indicated a higher level of pain intensity. If the FLACC scale exceeds three, IV paracetamol (15 mg/kg) will be given.
Measured: 24 hours postoperatively
Intraoperative fentanyl consumption
Additional fentanyl bolus dosages of 1 µg/kg IV will be administered if heart rate or mean arterial blood pressure elevated more than 20% of the baseline (after exclusion of other causes than pain).
Measured: Intraoperatively
Degree of pain
Degree of pain will be assessed using the Face, legs, activity, cry, and consolability (FLACC) scale. Each of the five items of the FLACC scale will be scared, ranging from 0 to 2, which will be then aggregated to obtain a total score ranging from 0 to 10. Higher scores on the scale indicated a higher level of pain intensity.
Measured: 24 hours postoperatively
Hear rate
Hear rate will be recorded preoperatively, before performing of block, and every 15 min till the end of surgery.
Measured: Every 15 min till the end of surgery (Up to 2 hours)
Mean arterial pressure
Mean arterial pressure will be recorded preoperatively, before performing of block, and every 15 min till the end of surgery.
Measured: Every 15 min till the end of surgery (Up to 2 hours)
Degree of patient's parents satisfaction
Degree of patient's parents satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)
Measured: 24 hours postoperatively
Incidence of adverse events
Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication related to block such as hematoma, neurological injury, deep visceral injury, or local anesthetic toxicity will be recorded.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start11 Dec 2024
- Primary completion6 Dec 2025
- Study completion6 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasoundStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Said ElSharkawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725667
- Sponsor's protocol ID
- 36264PR935/11/24
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2024
- Last updated
- 30 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Transversalis Fascia Plane Block Versus Caudal Block for Postoperative Analgesia in Children Undergoing Inguinal Herniorrhaphy: A Randomized Controlled Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT06725667
- Acronym / sponsor ID
- 36264PR935/11/24
- Conditions
- Ultrasound, Transversalis Fascia Plane Block, Caudal Block, Postoperative Analgesia, Children, Inguinal Herniorrhaphy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 11 Dec 2024 (actual)
- Primary completion
- 6 Dec 2025 (actual)
- Study completion
- 6 Dec 2025 (actual)
- First posted
- 10 Dec 2024 (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 compare ultrasound-guided transversalis fascia plane block and caudal block for postoperative analgesia in children undergoing inguinal herniorrhaphy.
Detailed description
Surgical repair of inguinal hernia is one of the most common day-case surgeries in the pediatric population. It is associated with significant postoperative pain and discomfort.
Caudal block analgesia is a popular and reliable technique for lower abdominal surgeries and found to be safe and effective for providing intra and postoperative analgesia in pediatric patients.
transversal fascia plane block (TFPB) aims to provide analgesia for invasive procedures of the inguinal and sublingual areas by blocking the subcostal (T12), ilioinguinal (L1) and iliohypogastric (T12-L1) nerves. Several studies have reported TFPB as the analgesic method of choice for procedures involving the T12-L1 dermatome region, including iliac bone graft harvesting, cesarean section, and inguinal hernia repair
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transversalis fascia plane block group | Experimental | Other: Transversalis fascia plane blockPatients will receive transversalis fascia plane block after the induction of general anesthesia. |
| Caudal block group | Active comparator | Other: Caudal blockPatients will receive caudal block after the induction of general anesthesia. |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age from 1 to 7 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-II.
- Scheduled for inguinal herniorrhaphy under general anesthesia (GA).
Key exclusion criteria (5 listed)
- Repeated surgeries.
- Known allergic reactions to any of the study's drugs.
- Infection at the site of block needle entry.
- Bleeding diathesis.
- Neurological disorders.
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 |
|---|---|---|
| Transversalis fascia plane blockPatients will receive transversalis fascia plane block after the induction of general anesthesia. | Other | Transversalis fascia plane block group |
| Caudal blockPatients will receive caudal block after the induction of general anesthesia. | Other | Caudal block group |
Primary outcome
Time to the 1st rescue analgesia
Time frame: 24 hours postoperatively
Time to the first request for the rescue analgesia (time from the end of surgery to first dose of paracetamol administrated).
7 secondary outcomes
Total paracetamol consumption
Time frame: 24 hours postoperatively
Intraoperative fentanyl consumption
Time frame: Intraoperatively
Degree of pain
Time frame: 24 hours postoperatively
Hear rate
Time frame: Every 15 min till the end of surgery (Up to 2 hours)
Mean arterial pressure
Time frame: Every 15 min till the end of surgery (Up to 2 hours)
Degree of patient's parents satisfaction
Time frame: 24 hours postoperatively
Incidence of adverse events
Time frame: 24 hours postoperatively
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 30 Dec 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Ultrasound
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
Active, not recruiting
Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis
Spondyloarthritis (SpA), Axial Spondylarthritis (axSpA)
Recruiting
Minimum Effective Local Anesthetic Volume for Ultrasound Guided Superior Trunk Block
Musculoskeletal Diseases or Conditions
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
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 Transversalis fascia plane block and Caudal block in people with Ultrasound and Transversalis Fascia Plane Block, 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 4 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: finished, as of the sponsor's last update on 30 Dec 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?
Time to the 1st rescue analgesia (time frame: 24 hours postoperatively). 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 30 Dec 2025.