Pain ManagementNCT07286799
Comparison of the Analgesic Efficacy of Transversalis Fascia Plane Block and Posterior Quadratus Lumborum Block in Pediatric Patient Undergoing Orchiopexy: A Prospective Observational Study
An observational study of Pain Management and Orchiopexy, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial summary
It was planned to compare the analgesic efficacy of the transversalis fascia plane block and the posterior quadratus lumborum block in children aged 1 to 7 years undergoing orchiopexy, by evaluating their FLACC scores and the time to first postoperative analgesic requirement. Read more about this study
- Who is it for?
- Ages 1 year to 7 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pain Management, Orchiopexy, Transversalis Fascia Plane Block
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 1 Nov 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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
- Men only
- Healthy volunteers accepted
- Child
Study population: Children aged 1 to 7 years with ASA physical status I-II undergoing unilateral orchiopexy surgery.
Who may be able to join
- Children aged 1 to 7 years with ASA physical status I-II undergoing unilateral orchiopexy surgery.
Who cannot join
- ASA physical status ≥ III
- History of prematurity (gestational age < 37 weeks) Known coagulation disorders or bleeding tendency
- Infection, inflammation, or skin lesion at the injection site
- Known neurological or neuromuscular diseases
- Presence of significant cardiac or pulmonary disease (e.g., congenital heart disease, active asthma)
- Hepatic or renal dysfunction
Show all 11Show fewer
- Known allergy or hypersensitivity to local anesthetics (e.g., bupivacaine, lidocaine)
- Developmental delay or cognitive impairment that prevents accurate pain assessment
- Use of additional regional analgesia techniques (e.g., caudal block) during surgery
- Block failure or intraoperative complications requiring exclusion from protocol analysis
- Lack of parental consent for participation in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof. Dr. Cemil Taşcıoğlu Şehir Hastanesi
Istanbul, Şişli, 34384
About this study
Official title: Comparison of the Analgesic Efficacy of Posterior Quadratus Lumborum Block and Transversalis Fascia Plane Block in Children Undergoing Orchiopexy
It was planned to compare the analgesic efficacy of the transversalis fascia plane block and the posterior quadratus lumborum block in children aged 1 to 7 years undergoing orchiopexy, by evaluating their FLACC scores and the time to first postoperative analgesic requirement.
- Keywords
- Transversalis fascia plane block, Quadratus lumborum block, Orchiopexy, Pain management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children aged 1-7 years undergoing orchiopexy who received a transversalis fascia plane block. | Children aged 1-7 years undergoing orchiopexy who received a transversalis fascia plane block. | |
| Children Aged 1-7 Years Undergoing Orchiopexy Who Received a Posterior Quadratus Lumborum Block | Children Aged 1-7 Years Undergoing Orchiopexy Who Received a Posterior Quadratus Lumborum Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Analgesic Requirement After Surgery
The time elapsed from the end of surgery to the administration of the first rescue analgesic.
Measured: First 24 hours postoperatively
Secondary outcomes (1)
FLACC Pain Scores at Specified Time Intervals
Pain assessment using the Face, Legs, Activity, Cry, Consolability (FLACC) scale (score range: 0-10; higher scores indicate worse pain) at 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, and 24 hours postoperatively.
Measured: First 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 posted16 Dec 2025
- Study start1 May 2025
- Primary completion1 Nov 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reyhan Kucuk Erturk, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286799
- Sponsor's protocol ID
- E-48670771-514.9900
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2025
- Last updated
- 31 Dec 2025
- Results posted
- 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 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Analgesic Efficacy of Posterior Quadratus Lumborum Block and Transversalis Fascia Plane Block in Children Undergoing Orchiopexy
- ClinicalTrials.gov ID
- NCT07286799
- Acronym / sponsor ID
- E-48670771-514.9900
- Keywords
- Transversalis fascia plane block, Quadratus lumborum block, Orchiopexy, Pain management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 16 Dec 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.
It was planned to compare the analgesic efficacy of the transversalis fascia plane block and the posterior quadratus lumborum block in children aged 1 to 7 years undergoing orchiopexy, by evaluating their FLACC scores and the time to first postoperative analgesic requirement.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children aged 1-7 years undergoing orchiopexy who received a transversalis fascia plane block. | – | –Children aged 1-7 years undergoing orchiopexy who received a transversalis fascia plane block. |
| Children Aged 1-7 Years Undergoing Orchiopexy Who Received a Posterior Quadratus Lumborum Block | – | –Children Aged 1-7 Years Undergoing Orchiopexy Who Received a Posterior Quadratus Lumborum Block |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 1 to 7 years with ASA physical status I-II undergoing unilateral orchiopexy surgery.
Key inclusion criteria (1 listed)
- Children aged 1 to 7 years with ASA physical status I-II undergoing unilateral orchiopexy surgery.
Key exclusion criteria (11 listed)
- ASA physical status ≥ III
- History of prematurity (gestational age < 37 weeks) Known coagulation disorders or bleeding tendency
- Infection, inflammation, or skin lesion at the injection site
- Known neurological or neuromuscular diseases
- Presence of significant cardiac or pulmonary disease (e.g., congenital heart disease, active asthma)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to First Analgesic Requirement After Surgery
Time frame: First 24 hours postoperatively
The time elapsed from the end of surgery to the administration of the first rescue analgesic.
1 secondary outcome
FLACC Pain Scores at Specified Time Intervals
Time frame: First 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 31 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Pain Management
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
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?
An observational study of Pain Management and Orchiopexy, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization 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 1 inclusion and 11 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 31 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 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?
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 Analgesic Requirement After Surgery (time frame: First 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 31 Dec 2025.