SurgeryNCT03258736
Caudal Block Versus Ultrasound Guided Ilioinguinal/Iliohypogastric Block in Pediatric Patient
A study testing inguinal hernia surgery in people with Surgery, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The caudal block is the most common technique for inguinal surgery. Increased use of ultrasound in regional analgesia techniques has been improved the practise of the peripheral nerve blocks. Ilioinguinal and iliohypogastric nerve blocks are possible to alternative methods to the central blocks. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Surgery
- What is being tested?
- inguinal hernia surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Apr 2017to 30 Aug 2017
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Inclusion Criteria:1- 10 year- old who were scheduled to bilateral inguinal hernia surgery -
Exclusion Criteria: Patients with neurological disoder, reoperation for inguinal hernia surgery, coagulation disorder
-
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cerrahpasa Medical Faculty
Istanbul, Cerrahpasa, 34098
About this study
Official title: Comparison of Caudal Block and Ultrasound Guided Ilioinguinal/Iliohypogastric Block for Bilateral Inguinal Surgery in Pediatric Patient: A Prospective Randomized Trial
The caudal block is the most common technique for inguinal surgery. Increased use of ultrasound in regional analgesia techniques has been improved the practise of the peripheral nerve blocks. Ilioinguinal and iliohypogastric nerve blocks are possible to alternative methods to the central blocks. The aim of this study is to compare analgesic efficiency of caudal block and ultrasound guided Ilioinguinal and iliohypogastric nerve blocks for bilateral inguinal hernia in pediatric patients
Read the detailed description
In this prospective randomized study, pediatric patients between 1- 10 years old who were scheduled to bilateral inguinal hernia surgery wil be enrolled the study. The patients wil randomly assign to receive an ultrasound-guided Ilioinguinal/iliohypogastric block group or caudal block group Ilioinguinal/iliohypogastric block was performed with 2 mg/kg bupivacaine as 0.25 % and total volum wil be divided equally for each side, Caudal block wil performe with bupivacaine 2 mg/kg as 0.2%. Supplemental analgesia will consist of as requred intraoperative remifentanyl, for recovery unit rescue tramadol, as requred at home ibuprofen. Patients wil be evaluated in the recovery unit for analgesia with FLACC pain scale, analgesic requirement, complications and parental satisfaction. Parents will be also called for analgesia and satisfaction after discharge of the patients in first 24 hours. The evaluation will be performed by a researcher whom does not know which participants belong to the caudal or ilioinguinal/iliohypogastric nerve block group
- Conditions
- Surgery
- Being tested
- inguinal hernia surgery
- Keywords
- pediatric, inguinal hernia, caudal, ilioinguinal/ilioihypogastric
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inguinal hernia surgeryProcedure or surgery
repair of inguinal hernia
| Study group | Role | What they receive |
|---|---|---|
| Caudal block | Other | Caudal block Marcaine Receives: Procedure: inguinal hernia surgery |
| ilionguinal/iliohypogastric block | Other | ilionguinal/iliohypogastric block Marcaine Receives: Procedure: inguinal hernia surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic requirements
FLACC score
Measured: up to 24 hours
Secondary outcomes (1)
Postoperative complications
Bromage scale
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start4 Apr 2017
- Primary completion30 Aug 2017
- Study completion30 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Istanbul 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Cigdem Tutuncu, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03258736
- Sponsor's protocol ID
- 604.01/02-7626
- Status last verified
- Apr 2017
- First submitted
- 20 Aug 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availabe from the authors
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Caudal Block and Ultrasound Guided Ilioinguinal/Iliohypogastric Block for Bilateral Inguinal Surgery in Pediatric Patient: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT03258736
- Acronym / sponsor ID
- 604.01/02-7626
- Conditions
- Surgery
- Keywords
- pediatric, inguinal hernia, caudal, ilioinguinal/ilioihypogastric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 23 Aug 2017 (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 caudal block is the most common technique for inguinal surgery. Increased use of ultrasound in regional analgesia techniques has been improved the practise of the peripheral nerve blocks. Ilioinguinal and iliohypogastric nerve blocks are possible to alternative methods to the central blocks. The aim of this study is to compare analgesic efficiency of caudal block and ultrasound guided Ilioinguinal and iliohypogastric nerve blocks for bilateral inguinal hernia in pediatric patients
Detailed description
In this prospective randomized study, pediatric patients between 1- 10 years old who were scheduled to bilateral inguinal hernia surgery wil be enrolled the study. The patients wil randomly assign to receive an ultrasound-guided Ilioinguinal/iliohypogastric block group or caudal block group Ilioinguinal/iliohypogastric block was performed with 2 mg/kg bupivacaine as 0.25 % and total volum wil be divided equally for each side, Caudal block wil performe with bupivacaine 2 mg/kg as 0.2%. Supplemental analgesia will consist of as requred intraoperative remifentanyl, for recovery unit rescue tramadol, as requred at home ibuprofen. Patients wil be evaluated in the recovery unit for analgesia with FLACC pain scale, analgesic requirement, complications and parental satisfaction. Parents will be also called for analgesia and satisfaction after discharge of the patients in first 24 hours. The evaluation will be performed by a researcher whom does not know which participants belong to the caudal or ilioinguinal/iliohypogastric nerve block group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caudal block | Other | Procedure: inguinal hernia surgeryCaudal block Marcaine |
| ilionguinal/iliohypogastric block | Other | Procedure: inguinal hernia surgeryilionguinal/iliohypogastric block Marcaine |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not 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 |
|---|---|---|
| inguinal hernia surgeryrepair of inguinal hernia | Procedure or surgery | Caudal block, ilionguinal/iliohypogastric block |
Primary outcome
Analgesic requirements
Time frame: up to 24 hours
FLACC score
1 secondary outcome
Postoperative complications
Time frame: up to 24 hours
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 Nov 2017.
- Individual participant dataSharing planned: No. Availabe from the authors
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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 inguinal hernia surgery in people with Surgery, run by Istanbul 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?
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 Nov 2017. 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?
Analgesic requirements (time frame: up to 24 hours). 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 Nov 2017.