Fascia Transversalis Plane BlockPhase 2NCT06326944
Fascia Transversalis Versus Transversus Abdominis Plane Block for Children Undergoing Inguinal Hernia Surgery
A Phase 2 study testing Ultrasound- guided Fascia Transversalis plane block, Ultrasound-guided Transversus abdominus plane block and Fentanyl in people with Fascia Transversalis Plane Block, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Fascia transversalis block in pediatrics undergoing inguinal surgical repair may be simple technique and may give longer effect in reduction of post-operative pain in comparison to transversus abdominis plane block. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Fascia Transversalis Plane Block
- What is being tested?
- Ultrasound- guided Fascia Transversalis plane block, Ultrasound-guided Transversus abdominus plane block and Fentanyl
- Type of treatment
- Injection or infusion, 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 Apr 2024to 10 Oct 2024
- Phase
- Phase 2
- 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 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA physical status I-II
Who cannot join
- Parents' refusal to participate in the study.
- Coagulopathy (i.e. Platelets ≤ 50,000 and/or INR> 1.5).
- Localized infection at the site of needle insertion.
- Known hypersensitivity or allergies to any of the used drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Effect of Fascia Transversalis Block Versus Transversus Abdominal Plane Block in Children Undergoing Open Inguinal Hernia Surgery. A Randomized Comparative Trial.
Fascia transversalis block in pediatrics undergoing inguinal surgical repair may be simple technique and may give longer effect in reduction of post-operative pain in comparison to transversus abdominis plane block.
Read the detailed description
All children will be assessed clinically, and investigations will be done to exclude the exclusion criteria mentioned above. Laboratory works needed: complete blood count (CBC), prothrombin time, concentration, partial thromboplastin time Intra-operative management Premedication by intramuscular injection of atropine 0.02 mg/Kg and midazolam 0.2 mg/Kg will be followed by insertion of intravenous (I.V) cannula.
General anesthesia will be induced in supine position under standard basic monitoring of vital signs with inhalational anesthetic using (100%) O2 + Sevoflurane. After deepening of the anesthesia, atracurium 0.5mg/kg and fentanyl 1μg/kg patients will be given, Endotracheal intubation will then follow by appropriate size of endotracheal tube. Volume control ventilation (VCV) 5-7 ml/kg and respiratory rate will be adjusted to keep and PaCO2 levels between 30-35 mmHg using (G.E-Datex-Ohmeda, Avance CS2, USA) anesthesia machine. Anesthesia will be maintained with isoflurane 1 MAC with 50% oxygen in air, and atracurium top-ups of 0.1mg/kg will be given every 30 minutes for neuromuscular blockade.
The Block will be performed using Sonosite S-Nerve Portable Ultrasound and SLAX/13-6 MHZ transducer will be used. 0.4 ml/kg bupivacaine 0.25% will be installed in the block plane. After receiving the block, surgical incision will be allowed to be done after 15 minutes.
Continuous recording of heart rate, blood pressure, will be carried out from the moment of injection at timely intervals intra-operative.
Increase of HR BP. >30% of baseline Indicates failure of block so fentanyl will be given at 1 mic / kg intra-operative.
Postoperative pain assessment using FLACC score will then follow till 6 hours
- Conditions
- Fascia Transversalis Plane Block
- Being tested
- Ultrasound- guided Fascia Transversalis plane block, Ultrasound-guided Transversus abdominus plane block, Fentanyl, Pethidine, Acetaminophen
- Keywords
- Transversus abdominis plane block, Open inguinal herniorrhaphy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound- guided Fascia Transversalis plane blockProcedure or surgery
Ultrasound probe will be placed in a transverse orientation above the iliac crest; and the external oblique, internal oblique (IO), and transversus abdominis TA muscles will be identified and traced posteriorly until first the TA muscle and then the IO muscle tapered into their common aponeurosis, adjacent to the quadratus lumborum muscle. The tip of a 22-gauge 80-mm block needle will be positioned just deep to the TA muscle and its aponeurosis at the point where the TA is tapered off. 0.4 ml/kg bupivacaine 0.25% will be injected into the plane between the TA and underlying transversalis fascia
Ultrasound-guided Transversus abdominus plane blockProcedure or surgery
the probe will be placed transversely in the mid-axillary line between the iliac crest and the costal margin at the level of the umbilicus. The external oblique, internal oblique and transversus abdominis muscles and their fascias will be visualized. A 22 gauge, 80 mm needle will be introduced anteriorly and in the plane of the ultrasound probe, and on entering the plane between IO and TA, 2 ml of 0.9% saline will be injected to verify the correct position of the needle. Following negative aspiration, 0.4 ml/kg of bupivacaine 0.25% will be injected.
FentanylDrug
patients will receive an induction dose at 1 mcg/kg. If the analgesia was inadequate in the form of increase in heart rate and or arterial blood pressure by more than 20% of baseline values during surgery, this warrants the administration of intravenous fentanyl (0.5µg/kg).
PethidineDrug
Also called Rescue analgesia
Pethidine IV will be given as rescue analgesia (0.5 mg/kg) if the FLACC pain score was more than 4 , the maximum allowed dose is 1mg/kg every 4 hours.
AcetaminophenDrug
patients will be given paracetamol (15 mg /kg/8 hrs ).
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Patients will receive fascia transversalis block Receives: Procedure: Ultrasound- guided Fascia Transversalis plane block; Drug: Fentanyl; Drug: Pethidine; Drug: Acetaminophen |
| Group B | Active comparator | Patients will receive Transversus abdominus plane block Receives: Procedure: Ultrasound-guided Transversus abdominus plane block; Drug: Fentanyl; Drug: Pethidine; Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First need of analgesia
time (minutes) to First need of rescue analgesia
Measured: First 6 hours postoperative
Secondary outcomes (2)
Total Pethidine Consumption
Total postoperative rescue morphine consumption in mg/kg for each group in the first 24 hours post-operative period.
Measured: First 6 hours postoperative
Postoperative pain assessment FLACC
In the PACU, quality of analgesia was assessed every 15 minutes for the first hour then at 2,4 ,and 6 hours postoperative using (face, legs, activity, and cry consolability scale) (FLACC) pain score
Measured: First 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 posted22 Mar 2024
- Study start1 Apr 2024
- Primary completion15 Sep 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fascia Transversalis Plane BlockStudies 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 2
- 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
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, maged gamal, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326944
- Sponsor's protocol ID
- MS-527-2023
- Status last verified
- Mar 2024
- First submitted
- 18 Mar 2024
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- 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 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Fascia Transversalis Block Versus Transversus Abdominal Plane Block in Children Undergoing Open Inguinal Hernia Surgery. A Randomized Comparative Trial.
- ClinicalTrials.gov ID
- NCT06326944
- Acronym / sponsor ID
- MS-527-2023
- Conditions
- Fascia Transversalis Plane Block
- Keywords
- Transversus abdominis plane block, Open inguinal herniorrhaphy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 22 Mar 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.
Fascia transversalis block in pediatrics undergoing inguinal surgical repair may be simple technique and may give longer effect in reduction of post-operative pain in comparison to transversus abdominis plane block.
Detailed description
All children will be assessed clinically, and investigations will be done to exclude the exclusion criteria mentioned above. Laboratory works needed: complete blood count (CBC), prothrombin time, concentration, partial thromboplastin time Intra-operative management Premedication by intramuscular injection of atropine 0.02 mg/Kg and midazolam 0.2 mg/Kg will be followed by insertion of intravenous (I.V) cannula.
General anesthesia will be induced in supine position under standard basic monitoring of vital signs with inhalational anesthetic using (100%) O2 + Sevoflurane. After deepening of the anesthesia, atracurium 0.5mg/kg and fentanyl 1μg/kg patients will be given, Endotracheal intubation will then follow by appropriate size of endotracheal tube. Volume control ventilation (VCV) 5-7 ml/kg and respiratory rate will be adjusted to keep and PaCO2 levels between 30-35 mmHg using (G.E-Datex-Ohmeda, Avance CS2, USA) anesthesia machine. Anesthesia will be maintained with isoflurane 1 MAC with 50% oxygen in air, and atracurium top-ups of 0.1mg/kg will be given every 30 minutes for neuromuscular blockade.
The Block will be performed using Sonosite S-Nerve Portable Ultrasound and SLAX/13-6 MHZ transducer will be used. 0.4 ml/kg bupivacaine 0.25% will be installed in the block plane. After receiving the block, surgical incision will be allowed to be done after 15 minutes.
Continuous recording of heart rate, blood pressure, will be carried out from the moment of injection at timely intervals intra-operative.
Increase of HR BP. >30% of baseline Indicates failure of block so fentanyl will be given at 1 mic / kg intra-operative.
Postoperative pain assessment using FLACC score will then follow till 6 hours
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 |
|---|---|---|
| Group A | Active comparator | Procedure: Ultrasound- guided Fascia Transversalis plane block, Drug: Fentanyl, Drug: Pethidine, Drug: AcetaminophenPatients will receive fascia transversalis block |
| Group B | Active comparator | Procedure: Ultrasound-guided Transversus abdominus plane block, Drug: Fentanyl, Drug: Pethidine, Drug: AcetaminophenPatients will receive Transversus abdominus plane block |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- ASA physical status I-II
Key exclusion criteria (4 listed)
- Parents' refusal to participate in the study.
- Coagulopathy (i.e. Platelets ≤ 50,000 and/or INR> 1.5).
- Localized infection at the site of needle insertion.
- Known hypersensitivity or allergies to any of the used drugs.
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 Fascia Transversalis plane blockUltrasound probe will be placed in a transverse orientation above the iliac crest; and the external oblique, internal oblique (IO), and transversus abdominis TA muscles will be identified and traced posteriorly until first the TA muscle and then the IO muscle tapered into their common aponeurosis, adjacent to the quadratus lumborum muscle. The tip of a 22-gauge 80-mm block needle will be positioned just deep to the TA muscle and its aponeurosis at the point where the TA is tapered off. 0.4 ml/kg bupivacaine 0.25% will be injected into the plane between the TA and underlying transversalis fascia | Procedure or surgery | Group A |
| Ultrasound-guided Transversus abdominus plane blockthe probe will be placed transversely in the mid-axillary line between the iliac crest and the costal margin at the level of the umbilicus. The external oblique, internal oblique and transversus abdominis muscles and their fascias will be visualized. A 22 gauge, 80 mm needle will be introduced anteriorly and in the plane of the ultrasound probe, and on entering the plane between IO and TA, 2 ml of 0.9% saline will be injected to verify the correct position of the needle. Following negative aspiration, 0.4 ml/kg of bupivacaine 0.25% will be injected. | Procedure or surgery | Group B |
| Fentanylpatients will receive an induction dose at 1 mcg/kg. If the analgesia was inadequate in the form of increase in heart rate and or arterial blood pressure by more than 20% of baseline values during surgery, this warrants the administration of intravenous fentanyl (0.5µg/kg). | Drug | Group A, Group B |
| PethidineAlso: Rescue analgesiaPethidine IV will be given as rescue analgesia (0.5 mg/kg) if the FLACC pain score was more than 4 , the maximum allowed dose is 1mg/kg every 4 hours. | Drug | Group A, Group B |
| Acetaminophenpatients will be given paracetamol (15 mg /kg/8 hrs ). | Drug | Group A, Group B |
Primary outcome
Time to First need of analgesia
Time frame: First 6 hours postoperative
time (minutes) to First need of rescue analgesia
2 secondary outcomes
Total Pethidine Consumption
Time frame: First 6 hours postoperative
Postoperative pain assessment FLACC
Time frame: First 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 16 Jun 2026.
- 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 Phase 2 study testing Ultrasound- guided Fascia Transversalis plane block, Ultrasound-guided Transversus abdominus plane block and Fentanyl in people with Fascia Transversalis Plane Block, run by Kasr El Aini Hospital 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 4 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 16 Jun 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 First need of analgesia (time frame: First 6 hours postoperative). 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 16 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.