Post Operative Pain, AcutePhase 3NCT07235475
Comparison Between the Analgesic Effect of Fascia Transversalis Block vs Caudal Block
A Phase 3 study testing Caudal Block Anesthesia and Fascia Transversalis Block in people with Post Operative Pain, Acute, run by Cairo University at 1 site in Egypt.
Trial summary
Despite the growing interest in interfascial blocks and their successful use in pediatric surgeries, no previous randomized clinical trials have directly compared the analgesic efficacy, opioid-sparing effect, and safety profile of the fascia transversalis block versus the caudal block in pediatric patients undergoing… Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Post Operative Pain, Acute
- What is being tested?
- Caudal Block Anesthesia and Fascia Transversalis Block
- 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
- 20 Nov 2025to 14 Apr 2026
- Phase
- Phase 3
- 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
- ASA physical status I or II, scheduled for elective unilateral inguinal hernia surgery under general anesthesia
Who cannot join
- Parental refusal.
- Pre-existing infection at block site.
- Coagulopathy (defined as INR >1.5, Platelets <100,000).
- Known allergy to local anesthetics.
- History of complications from regional anesthesia.
- Emergency or bilateral hernia repair.
- Neurodevelopmental disorders (e.g., cerebral palsy, spina bifida).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between the Analgesic Effect of Fascia Transversalis Block vs Caudal Block in Pediatrics Undergoing Inguinal Hernia Surgeries: Randomized Double-blinded Comparative Study
Despite the growing interest in interfascial blocks and their successful use in pediatric surgeries, no previous randomized clinical trials have directly compared the analgesic efficacy, opioid-sparing effect, and safety profile of the fascia transversalis block versus the caudal block in pediatric patients undergoing unilateral inguinal hernia repair. This study aims to address this gap by providing the first head-to-head randomized comparison between both blocks in a standardized surgical setting
- Conditions
- Post Operative Pain, Acute
- Being tested
- Caudal Block Anesthesia, Fascia Transversalis Block
- 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 Block AnesthesiaProcedure or surgery
Patients will receive a caudal block with 0.5 mL/kg of Bupivacaine 0.25% injected. The commercial preparation that will be used is Bupivacaine HCl (Sunny Pharmaceutical, Egypt)
Fascia Transversalis BlockProcedure or surgery
Patients will receive Fascia Transversalis Block using 0.5 mL/kg of Bupivacaine 0.25% . The commercial preparation that will be used is Bupivacaine HCl (Sunny Pharmaceutical, Egypt)
| Study group | Role | What they receive |
|---|---|---|
| Fascia Transversalis Block | Active comparator | Patients will receive Fascia Transversalis Block Receives: Procedure: Fascia Transversalis Block |
| caudal block | Active comparator | Patients will receive caudal block Receives: Procedure: Caudal Block Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the first request for rescue analgesia
the interval between the end of surgery (extubation) and the first need for analgesia (paracetamol)
Measured: 24 hours post-operatively
Secondary outcomes (4)
Total intraoperative fentanyl consumption
Measured: from the start of general anesthesia until the extubation
Postoperative FLACC (Face, Legs, Activity, Cry, Consolability) pain scores
Each of the five behaviors will be scored on a scale of 0 to 2. The scores are then added together to get a total score, which can range from 0 (no pain) to 10 (severe pain).
Measured: 24 hours postoperatively
Total paracetamol dose in 24 hours
Measured: 24 hours postoperatively
Parental satisfaction score
Will be measured using a 5-point Likert scale:
- = Extremely dissatisfied
- = Unsatisfied
- = Neutral
- = Satisfied
- = Extremely satisfied
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 posted19 Nov 2025
- Study start20 Nov 2025
- Primary completion1 Apr 2026
- Study completion14 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Pain, AcuteStudies of the same condition, open and under way.
- More trials run by Cairo 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 3
- 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
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AbdElKhalik Mahmoud Shaban, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07235475
- Sponsor's protocol ID
- MS-393-2025
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 17 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Analgesic Effect of Fascia Transversalis Block vs Caudal Block in Pediatrics Undergoing Inguinal Hernia Surgeries: Randomized Double-blinded Comparative Study
- ClinicalTrials.gov ID
- NCT07235475
- Acronym / sponsor ID
- MS-393-2025
- Conditions
- Post Operative Pain, Acute
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 14 Apr 2026 (actual)
- First posted
- 19 Nov 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.
Despite the growing interest in interfascial blocks and their successful use in pediatric surgeries, no previous randomized clinical trials have directly compared the analgesic efficacy, opioid-sparing effect, and safety profile of the fascia transversalis block versus the caudal block in pediatric patients undergoing unilateral inguinal hernia repair. This study aims to address this gap by providing the first head-to-head randomized comparison between both blocks in a standardized surgical setting
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fascia Transversalis Block | Active comparator | Procedure: Fascia Transversalis BlockPatients will receive Fascia Transversalis Block |
| caudal block | Active comparator | Procedure: Caudal Block AnesthesiaPatients will receive caudal block |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- ASA physical status I or II, scheduled for elective unilateral inguinal hernia surgery under general anesthesia
Key exclusion criteria (7 listed)
- Parental refusal.
- Pre-existing infection at block site.
- Coagulopathy (defined as INR >1.5, Platelets <100,000).
- Known allergy to local anesthetics.
- History of complications from regional anesthesia.
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 Block AnesthesiaPatients will receive a caudal block with 0.5 mL/kg of Bupivacaine 0.25% injected. The commercial preparation that will be used is Bupivacaine HCl (Sunny Pharmaceutical, Egypt) | Procedure or surgery | caudal block |
| Fascia Transversalis BlockPatients will receive Fascia Transversalis Block using 0.5 mL/kg of Bupivacaine 0.25% . The commercial preparation that will be used is Bupivacaine HCl (Sunny Pharmaceutical, Egypt) | Procedure or surgery | Fascia Transversalis Block |
Primary outcome
Time to the first request for rescue analgesia
Time frame: 24 hours post-operatively
the interval between the end of surgery (extubation) and the first need for analgesia (paracetamol)
4 secondary outcomes
Total intraoperative fentanyl consumption
Time frame: from the start of general anesthesia until the extubation
Postoperative FLACC (Face, Legs, Activity, Cry, Consolability) pain scores
Time frame: 24 hours postoperatively
Total paracetamol dose in 24 hours
Time frame: 24 hours postoperatively
Parental satisfaction score
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 17 Apr 2026.
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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 Phase 3 study testing Caudal Block Anesthesia and Fascia Transversalis Block in people with Post Operative Pain, Acute, run by Cairo 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 7 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 Apr 2026. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 first request for rescue analgesia (time frame: 24 hours post-operatively). 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 Apr 2026.