Pain, PostoperativeNCT06391528
Transversalis Fascia Plane Block in Pediatric Patients
A study testing Transversalis Fascia Plane Block in people with Pain, Postoperative and Regional Anesthesia, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
to investigate the effects of Transversalis Fascia Plan Block after induction of anesthesia on perioperative opioid consumption, hemodynamic changes, postoperative FLACC pediatric pain score, non-opioid analgesic use and parental satisfaction in pediatric patients undergoing unilateral inguinal hernia or undescended… Read more about this study
- Who is it for?
- Ages 1 year to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Regional Anesthesia, Parental Satisfaction
- What is being tested?
- Transversalis Fascia Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 30 Jun 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 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1-9 years old
- ASA I-II risk group
- Patients whose consent was obtained from their parents with an informed consent form
- Patients who will undergo Inguinal Hernia or Undescended Testi
Who cannot join
- ASA >2
- History of allergy to local anesthetics
- Known coagulation disorders
- Infection near the entry site
- Body mass index >30
- Those whose parents refused to participate in the study
Show all 12Show fewer
- Those contraindicated for regional anesthesia
- Those with neurological or neuromuscular disease
- Patients with psychiatric problems
- Patients with a history of opioid use
- Chronic analgesic use
- Operation duration exceeding 2 hours
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguldak Bülent Ecevit University medicine faculty
Zonguldak, Kozlu, 67600
About this study
Official title: Effects of Transversalis Fascia Plane Block in Pediatric Patients Undergoing Inguinal Hernia and Orchiopexy Surgeries
to investigate the effects of Transversalis Fascia Plan Block after induction of anesthesia on perioperative opioid consumption, hemodynamic changes, postoperative FLACC pediatric pain score, non-opioid analgesic use and parental satisfaction in pediatric patients undergoing unilateral inguinal hernia or undescended testicular repair under general anesthesia.
- Being tested
- Transversalis Fascia Plane Block
- Keywords
- postoperative pain, pain scores
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversalis Fascia Plane BlockProcedure or surgery
application of local anesthetic between the transversus abdominis muscle and the transversalis fascia surrounding it from the inside, at the level of the posterior axillary line.
| Study group | Role | What they receive |
|---|---|---|
| Group Control | No intervention | Not described |
| Group FTB | Active comparator | Not described Receives: Procedure: Transversalis Fascia Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain scores
Patients will be evaluated at regular intervals after surgery and their pain will be measured using a FLACC scores.
Measured: up to 24 hour after surgery
Secondary outcomes (1)
parental satisfaction
asking parents about their satisfaction
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start1 Apr 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çağdaş Baytar, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391528
- Sponsor's protocol ID
- 2024/06-19
- Status last verified
- Apr 2024
- First submitted
- 26 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transversalis Fascia Plane Block in Pediatric Patients Undergoing Inguinal Hernia and Orchiopexy Surgeries
- ClinicalTrials.gov ID
- NCT06391528
- Acronym / sponsor ID
- 2024/06-19
- Keywords
- postoperative pain, pain scores
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 30 Apr 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.
to investigate the effects of Transversalis Fascia Plan Block after induction of anesthesia on perioperative opioid consumption, hemodynamic changes, postoperative FLACC pediatric pain score, non-opioid analgesic use and parental satisfaction in pediatric patients undergoing unilateral inguinal hernia or undescended testicular repair under general anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Control | No intervention | – |
| Group FTB | Active comparator | Procedure: Transversalis Fascia Plane Block |
Who may qualify
- Ages
- 1 year to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 1-9 years old
- ASA I-II risk group
- Patients whose consent was obtained from their parents with an informed consent form
- Patients who will undergo Inguinal Hernia or Undescended Testi
Key exclusion criteria (12 listed)
- ASA >2
- History of allergy to local anesthetics
- Known coagulation disorders
- Infection near the entry site
- Body mass index >30
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 Blockapplication of local anesthetic between the transversus abdominis muscle and the transversalis fascia surrounding it from the inside, at the level of the posterior axillary line. | Procedure or surgery | Group FTB |
Primary outcome
postoperative pain scores
Time frame: up to 24 hour after surgery
Patients will be evaluated at regular intervals after surgery and their pain will be measured using a FLACC scores.
1 secondary outcome
parental satisfaction
Time frame: during the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Individual participant dataSharing planned: No
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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 Transversalis Fascia Plane Block in people with Pain, Postoperative and Regional Anesthesia, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
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 12 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: status not confirmed, as of the sponsor's last update on 30 Apr 2024. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
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?
postoperative pain scores (time frame: up to 24 hour after surgery). 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 Apr 2024.