Ultrasound ImagingNCT04671992
Out Of-plane Technique Against In-plane for Caudal Block
A study testing Out of-Plane Technique and In-Plane on in people with Ultrasound Imaging and Caudal Block, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
Caudal block is an easy and effective type of central neuraxial block that is widely used in subumbilical surgeries to provide intraoperative and postoperative analgesia in the pediatric population. Caudal block application with ultrasound (USG) was first applied in 2003. Read more about this study
- Who is it for?
- Ages 6 months to 10 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ultrasound Imaging, Caudal Block, Hypospadias
- What is being tested?
- Out of-Plane Technique and In-Plane on
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2020to 15 Apr 2021
- 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 6 months to 10 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Pediatric patients undergoing hypospadias surgery
- ASA PS I-II group
Who cannot join
- Previous neurological or spinal disorder,
- Coagulation anomaly
- Allergy to local anesthetics
- Local infection in the block area
- Children with a history of preterm birth
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Selcuk University, School of Medicine
Konya, 42080
About this study
Official title: Ultrasound Guided Out Of-Plane Technique Against İn-Plane Technique for Caudal Block in Pediatric Hypospadias Surgery: A Prospective Randomized Clinical Study
Caudal block is an easy and effective type of central neuraxial block that is widely used in subumbilical surgeries to provide intraoperative and postoperative analgesia in the pediatric population. Caudal block application with ultrasound (USG) was first applied in 2003. Sacrum, sacral cornular, sacrococcygeal ligament and sacral hiatus can be easily distinguished by ultrasound. The probe is positioned in a horizontal midline position on the lower sacrum. Sacral roots within the caudal epidural space can be seen as hypoechoic ellipses. In addition, anatomical variations of the sacral hiatus and the process area can be clearly observed. A accurate probe use with ultrasound guided is confirmed by advancing the caudal needle in the desired direction, widening in the sacral hiatus with local anesthetic injection, and the turbulence observed during injection into the sacral canal if the color doppler feature is used. Thus, a decrease in complications and an increase in the success of the procedure can be achieved with simultaneous imaging. In addition, in cases where the block is difficult, the in-plane technique can be preferred in the midline plane.The aim of this study is to compare the success rates and postoperative pain levels of caudal block applications with the out of plane technique (probe applied by holding horizontal) and in-plane technique (probe applied vertically), which is routinely applied with ultrasound in pediatric hypospadias surgery.
Read the detailed description
This study will be scheduled between January - March 2021 at Selcuk University Department of Anesthesiology and Reanimation. A total of 70 patients from American Society of Anesthesiologists classification physical status of (ASA-PS) I-II, aged 6 months to 10 years, will be included in the study. Routine monitoring electrocardiogram (ECG), peripheral oxygen saturation (SpO2) and non-invasive blood pressure measurements will be made to patients into the operating room, and their basal levels will be recorded. All patients were transferred to the operating room without premedication. The patients will be assigned to two groups as in-plane technique (Group IP) and out of-plane technique (Group OP) according to the program randomization list. Routine anesthesia induction will be performed with 7-8% sevoflurane, 100% oxygen until the patient loses consciousness with a face mask. Then, vascular access will be established and propofol 2-3 mg for general anesthesia induction. kg 1 and fentanyl 1 μg. kg-1 IV will be used. After the eyelash reflex disappears without any neuromuscular blocker medication, a suitable laryngeal mask airway device will be placed into supraglottic area, and the patient will be connected to the anesthesia device for ventilation. For the maintenance of anesthesia, 2% sevoflurane, nitrous oxide will be stopped, and 50% oxygen + air mixture will be used. For caudal epidural block, the patient will be turned to the lateral position. After the asepsis of the perianal region is achieved, the sterile 8-18 MHz lineer USG probe for Group OP will be placed transversely in the midline to obtain a transverse view in the sacral hiatus. For group IP, the probe will be rotated 90 degrees and applied with the in-plane technique. After it is observed that there is no blood or cerebrospinal fluid (CSF) with aspiration, local anesthetic (LA) injection will be performed under hemodynamic and ECG monitoring by calculating the dose as 0.5 mg.kg-1 (0.25% bupivacaine) and the volume as 0.5 ml.kg-1. A successful block will be defined as the absence of significant motor movements after surgical induction, after heart and respiratory rates do not increase up to 20% above basal levels. In addition, block application time, number of needle attempts, success at first entry, ease of visualization, LA spread will be recorded and evaluated as the success rate.
In both groups, the surgical caudal block will begin 10 minutes after anesthesia. Intraoperative opioids or sedative drugs will not be used. Mean arterial pressure, heart rate and oxygen saturation of the patients will be recorded every 5 minutes.
At the end of the surgery, patients will be extubated and followed up in the postoperative recovery unit. Postoperative pain 10 minutes, 30 minutes, 1st, 2nd, 3rd, 6th, 12th, 24th hours FLACC pain scale (Face Legs Activity Cry Consolabity = face , legs, activity, crying, consolation). Time to first analgesia requirement, total analgesic consumption and postoperative complications will be recorded. In the evaluations made to patients in both groups, if the FLACC scale is> 4, rescue analgesia will be administered intravenously with 15 mg.kg-1 paracetamol.
- Conditions
- Ultrasound Imaging, Caudal Block, Hypospadias
- Being tested
- Out of-Plane Technique and In-Plane on
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Out of-Plane Technique and In-Plane onDevice
A comparison of out of-plane technique and in-plane
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Guided Out of-Plane Technique | Active comparator | Ultrasound Guided Out of plane technique (probe applied by holding horizontal) Receives: Device: Out of-Plane Technique and In-Plane on |
| Ultrasound Guided In-Plane Technique | Active comparator | Ultrasound Guided Out of plane technique (probe applied by holding vbertical) Receives: Device: Out of-Plane Technique and In-Plane on |
What is being measured
The primary outcome is the main question the study is designed to answer.
the success rates of in-plane and out of-plane techniques
To measure success rates of in-plane and out-of-plane techniques for caudal block, the number of successful processing and the time of processing (minute) will be used
Measured: 4 months
Secondary outcomes (1)
The postoperative pain levels
Postoperative pain will be evaluated with the visual analog scale (VAS), the first analgesia requirement time will to be shown as "minute" and the total amount of analgesia consumed as "mg".
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start1 Dec 2020
- Primary completion31 Mar 2021 (estimated)
- Study completion15 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound ImagingStudies of the same condition, open and under way.
- More trials run by Selcuk 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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faruk Cicekci, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671992
- Sponsor's protocol ID
- farukcicekci3
- Status last verified
- Dec 2020
- First submitted
- 6 Dec 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I do not have a plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Out Of-Plane Technique Against İn-Plane Technique for Caudal Block in Pediatric Hypospadias Surgery: A Prospective Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT04671992
- Acronym / sponsor ID
- farukcicekci3
- Conditions
- Ultrasound Imaging, Caudal Block, Hypospadias
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 15 Apr 2021 (estimated)
- First posted
- 17 Dec 2020 (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.
Caudal block is an easy and effective type of central neuraxial block that is widely used in subumbilical surgeries to provide intraoperative and postoperative analgesia in the pediatric population. Caudal block application with ultrasound (USG) was first applied in 2003. Sacrum, sacral cornular, sacrococcygeal ligament and sacral hiatus can be easily distinguished by ultrasound. The probe is positioned in a horizontal midline position on the lower sacrum. Sacral roots within the caudal epidural space can be seen as hypoechoic ellipses. In addition, anatomical variations of the sacral hiatus and the process area can be clearly observed. A accurate probe use with ultrasound guided is confirmed by advancing the caudal needle in the desired direction, widening in the sacral hiatus with local anesthetic injection, and the turbulence observed during injection into the sacral canal if the color doppler feature is used. Thus, a decrease in complications and an increase in the success of the procedure can be achieved with simultaneous imaging. In addition, in cases where the block is difficult, the in-plane technique can be preferred in the midline plane.The aim of this study is to compare the success rates and postoperative pain levels of caudal block applications with the out of plane technique (probe applied by holding horizontal) and in-plane technique (probe applied vertically), which is routinely applied with ultrasound in pediatric hypospadias surgery.
Detailed description
This study will be scheduled between January - March 2021 at Selcuk University Department of Anesthesiology and Reanimation. A total of 70 patients from American Society of Anesthesiologists classification physical status of (ASA-PS) I-II, aged 6 months to 10 years, will be included in the study. Routine monitoring electrocardiogram (ECG), peripheral oxygen saturation (SpO2) and non-invasive blood pressure measurements will be made to patients into the operating room, and their basal levels will be recorded. All patients were transferred to the operating room without premedication. The patients will be assigned to two groups as in-plane technique (Group IP) and out of-plane technique (Group OP) according to the program randomization list. Routine anesthesia induction will be performed with 7-8% sevoflurane, 100% oxygen until the patient loses consciousness with a face mask. Then, vascular access will be established and propofol 2-3 mg for general anesthesia induction. kg 1 and fentanyl 1 μg. kg-1 IV will be used. After the eyelash reflex disappears without any neuromuscular blocker medication, a suitable laryngeal mask airway device will be placed into supraglottic area, and the patient will be connected to the anesthesia device for ventilation. For the maintenance of anesthesia, 2% sevoflurane, nitrous oxide will be stopped, and 50% oxygen + air mixture will be used. For caudal epidural block, the patient will be turned to the lateral position. After the asepsis of the perianal region is achieved, the sterile 8-18 MHz lineer USG probe for Group OP will be placed transversely in the midline to obtain a transverse view in the sacral hiatus. For group IP, the probe will be rotated 90 degrees and applied with the in-plane technique. After it is observed that there is no blood or cerebrospinal fluid (CSF) with aspiration, local anesthetic (LA) injection will be performed under hemodynamic and ECG monitoring by calculating the dose as 0.5 mg.kg-1 (0.25% bupivacaine) and the volume as 0.5 ml.kg-1. A successful block will be defined as the absence of significant motor movements after surgical induction, after heart and respiratory rates do not increase up to 20% above basal levels. In addition, block application time, number of needle attempts, success at first entry, ease of visualization, LA spread will be recorded and evaluated as the success rate.
In both groups, the surgical caudal block will begin 10 minutes after anesthesia. Intraoperative opioids or sedative drugs will not be used. Mean arterial pressure, heart rate and oxygen saturation of the patients will be recorded every 5 minutes.
At the end of the surgery, patients will be extubated and followed up in the postoperative recovery unit. Postoperative pain 10 minutes, 30 minutes, 1st, 2nd, 3rd, 6th, 12th, 24th hours FLACC pain scale (Face Legs Activity Cry Consolabity = face , legs, activity, crying, consolation). Time to first analgesia requirement, total analgesic consumption and postoperative complications will be recorded. In the evaluations made to patients in both groups, if the FLACC scale is> 4, rescue analgesia will be administered intravenously with 15 mg.kg-1 paracetamol.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Guided Out of-Plane Technique | Active comparator | Device: Out of-Plane Technique and In-Plane onUltrasound Guided Out of plane technique (probe applied by holding horizontal) |
| Ultrasound Guided In-Plane Technique | Active comparator | Device: Out of-Plane Technique and In-Plane onUltrasound Guided Out of plane technique (probe applied by holding vbertical) |
Who may qualify
- Ages
- 6 months to 10 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Pediatric patients undergoing hypospadias surgery
- ASA PS I-II group
Key exclusion criteria (5 listed)
- Previous neurological or spinal disorder,
- Coagulation anomaly
- Allergy to local anesthetics
- Local infection in the block area
- Children with a history of preterm birth
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 |
|---|---|---|
| Out of-Plane Technique and In-Plane onA comparison of out of-plane technique and in-plane | Device | Ultrasound Guided In-Plane Technique, Ultrasound Guided Out of-Plane Technique |
Primary outcome
the success rates of in-plane and out of-plane techniques
Time frame: 4 months
To measure success rates of in-plane and out-of-plane techniques for caudal block, the number of successful processing and the time of processing (minute) will be used
1 secondary outcome
The postoperative pain levels
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Individual participant dataSharing planned: No. I do not have a plan to make individual participant data (IPD) available to other researchers.
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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 Out of-Plane Technique and In-Plane on in people with Ultrasound Imaging and Caudal Block, run by Selcuk 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 2 inclusion and 5 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 17 Dec 2020. 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?
the success rates of in-plane and out of-plane techniques (time frame: 4 months). 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 Dec 2020.