Inguinal HerniaPhase 4NCT06883370
Analgesia Evaluation of an Ultrasound-guided Technique for Inguinal Hernia Surgery in Children in Children
A Phase 4 study testing ultrasound-guided transversals fascia plane block with ropivacaine in people with Inguinal Hernia and Surgery, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
The basis for the transversalis fascia plane (TFP) block involves infiltration of local anaesthetic blocking the ilioinguinal and iliohypogastric nerve which are located between the fascia of the transversus abdominis muscle and the transversalis fascia. Read more about this study
- Who is it for?
- Ages 6 months to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Inguinal Hernia, Surgery, Paediatric
- What is being tested?
- ultrasound-guided transversals fascia plane block with ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Dec 2023to 30 Nov 2024
- Phase
- Phase 4
- 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 6 months to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Inclusion Criteria: All ASA I or II patients undergoing inguinal hernia repair
Exclusion Criteria: Parent's refusal, allergic to study drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Evaluation of Ultrasound Guided Transversalis Fascia Plane (Tfp) Block With 0.4 ml/kg of Ropivacaine 0.375 % in Paediatric Laparoscopic Inguinal Hernia Repair.
The basis for the transversalis fascia plane (TFP) block involves infiltration of local anaesthetic blocking the ilioinguinal and iliohypogastric nerve which are located between the fascia of the transversus abdominis muscle and the transversalis fascia. The fascia of the transversus abdominis muscle, also called the thoracolumbar fascia, is formed when the transversus abdominis and internal oblique muscles taper off posteriorly into a common aponeurosis and abuts the lateral border of quadratus lumborum muscle. The transversalis fascia is a thin aponeurotic membrane which lies between the transversus abdominis muscle and the extraperitoneal fascia, and is part of the general layer of fascia lining the abdominal cavity. Thus the TFP block is said to be suitable for lower abdominal surgery.
This study was designed obtain the analgesic efficacy of ropivacaine 0.375% for ultrasound-guided (USG) TFP block for paediatric patients undergoing laparoscopic inguinal hernia.
Read the detailed description
Methods: Thirty-two ASA 1 or 2 patients, aged 6 months to 12 years old undergoing laparoscopic inguinal hernia repair were recruited into this study. They were all given 0.4ml/kg of ropivacaine 0.375% after induction of anaesthesia. Intra operative heart rate (HR), mean arterial pressure (MAP), cumulative fentanyl consumption as well as post operative FLACC score, post operative nausea and vomiting incidence, time to first oral intake, parental satisfaction and complications were recorded.
- Conditions
- Inguinal Hernia, Surgery, Paediatric
- Being tested
- ultrasound-guided transversals fascia plane block with ropivacaine
- Keywords
- Ultrasound, transversalis fascia, ropivacaine, inguinal hernia, paediatric patients
- 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 transversals fascia plane block with ropivacaineCombination product
using 0.375% ropivacaine of 0.4mls/kg
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | All paediatric patients undergoing inguinal hernia repair Receives: Combination Product: ultrasound-guided transversals fascia plane block with ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of ultrasound-guided transversals fascia plane block in paediatric
Pain score
Measured: immediate post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start1 Dec 2023
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr, Principal investigator, The National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883370
- Sponsor's protocol ID
- JEPUKM-JEP-2023-518
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Evaluation of Ultrasound Guided Transversalis Fascia Plane (Tfp) Block With 0.4 ml/kg of Ropivacaine 0.375 % in Paediatric Laparoscopic Inguinal Hernia Repair.
- ClinicalTrials.gov ID
- NCT06883370
- Acronym / sponsor ID
- JEPUKM-JEP-2023-518
- Conditions
- Inguinal Hernia, Surgery, Paediatric
- Keywords
- Ultrasound, transversalis fascia, ropivacaine, inguinal hernia, paediatric patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 19 Mar 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 basis for the transversalis fascia plane (TFP) block involves infiltration of local anaesthetic blocking the ilioinguinal and iliohypogastric nerve which are located between the fascia of the transversus abdominis muscle and the transversalis fascia. The fascia of the transversus abdominis muscle, also called the thoracolumbar fascia, is formed when the transversus abdominis and internal oblique muscles taper off posteriorly into a common aponeurosis and abuts the lateral border of quadratus lumborum muscle. The transversalis fascia is a thin aponeurotic membrane which lies between the transversus abdominis muscle and the extraperitoneal fascia, and is part of the general layer of fascia lining the abdominal cavity. Thus the TFP block is said to be suitable for lower abdominal surgery.
This study was designed obtain the analgesic efficacy of ropivacaine 0.375% for ultrasound-guided (USG) TFP block for paediatric patients undergoing laparoscopic inguinal hernia.
Detailed description
Methods: Thirty-two ASA 1 or 2 patients, aged 6 months to 12 years old undergoing laparoscopic inguinal hernia repair were recruited into this study. They were all given 0.4ml/kg of ropivacaine 0.375% after induction of anaesthesia. Intra operative heart rate (HR), mean arterial pressure (MAP), cumulative fentanyl consumption as well as post operative FLACC score, post operative nausea and vomiting incidence, time to first oral intake, parental satisfaction and complications were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Combination Product: ultrasound-guided transversals fascia plane block with ropivacaineAll paediatric patients undergoing inguinal hernia repair |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
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 transversals fascia plane block with ropivacaineusing 0.375% ropivacaine of 0.4mls/kg | Combination product | All patients |
Primary outcome
Effectiveness of ultrasound-guided transversals fascia plane block in paediatric
Time frame: immediate post operative
Pain score
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 20 Mar 2025.
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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.
Dr principal investigator
The National University of Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ultrasound-guided transversals fascia plane block with ropivacaine in people with Inguinal Hernia and Surgery, run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 20 Mar 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 Malaysia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Effectiveness of ultrasound-guided transversals fascia plane block in paediatric (time frame: immediate post 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 20 Mar 2025.