AnesthesiaNCT04691531
Decreasing the Invasiveness of Ultrasound Guided Caudal Block: A Comparison Between 22-gauge and 27-guage Needles
A study testing The use of classical Gauge 22 needle and The use of classical Gauge 27 needle in people with Anesthesia and Pain, run by University of Jordan at 1 site in Jordan.
Trial summary
Ultrasound (US) has facilitated the use of caudal block in children and visualization of the needle during insertion. This prospective clinical trial study compares between two different sizes of the used needles, in terms of success rate, number of punctures, detection of the US signs (visualization of the needle… Read more about this study
- Who is it for?
- Ages 6 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Pain, Caudal Block
- What is being tested?
- The use of classical Gauge 22 needle and The use of classical Gauge 27 needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteJordan
- Study dates
- 2 Jan 2021to 20 Apr 2022
- 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 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age between 6 months and 36 months
- Undergoing elective lower abdominal or perineal surgeries
Who cannot join
- Refusal of the legal guardian of the patient.
- Patients aging less than 6 months, or older than 36 months.
- Emergency surgeries.
- Coagulopathy.
- infection at the site of procedure.
- Uncorrected hypovolemia.
- Increased intracranial pressure.
- Congenital anomalies at the site of procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Decreasing the Invasiveness of Ultrasound Guided Caudal Block: A Randomized Controlled Trial Comparing Between 22-gauge and 27-guage Needles
Ultrasound (US) has facilitated the use of caudal block in children and visualization of the needle during insertion. This prospective clinical trial study compares between two different sizes of the used needles, in terms of success rate, number of punctures, detection of the US signs (visualization of the needle, dural displacement, turbulence, and distention), and complications in pediatrics aging between 6-36 months requiring elective lower abdominal and perineal surgeries.
Read the detailed description
Ultrasound (US) has facilitated the use of caudal block in children, allowing an initial assessment of the anatomy of the sacrum, including the relationship of the sacral hiatus to the dural sac ending. Real-time US allows visualization of the needle during insertion to reach the dural sac, and to see the turbulence and distention of the layers during injection of the local anesthetic drug.
This prospective clinical trial study compares between two different sizes of the used needles, in terms of success rate, number of punctures, detection of the US signs (visualization of the needle, dural displacement, turbulence, and distention), and complications in pediatrics aging between 6-36 months requiring elective lower abdominal and perineal surgeries.
- Conditions
- Anesthesia, Pain, Caudal Block, Pediatric Anesthesia, Abdominal Surgeries
- Being tested
- The use of classical Gauge 22 needle, The use of classical Gauge 27 needle
- Keywords
- Caudal block, Ultrasound, Pediatric anesthesia, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The use of classical Gauge 22 needleDevice
After induction of general anesthesia, patients will undergo caudal block by using classical Gauge 22 needle under ultrasound guidance using a linear probe 5.5-12 MHz.
The use of classical Gauge 27 needleDevice
After induction of general anesthesia, patients will undergo caudal block by using Gauge 27 needle under ultrasound guidance using a linear probe 5.5-12 MHz.
| Study group | Role | What they receive |
|---|---|---|
| group C | Experimental | After induction of general anesthesia, patients will undergo caudal block by classical Gauge 22 needle under ultrasound guidance using a linear probe 5.5-12 MHz, and Bupivacaine 1 ml/kg of 0.25% will be injected. Receives: Device: The use of classical Gauge 22 needle |
| Group S | Experimental | After induction of general anesthesia, patients will undergo caudal block by Gauge 27 needle under ultrasound guidance using a linear probe 5.5-12 MHz, and Bupivacaine 1 ml/kg of 0.25% will be injected. Receives: Device: The use of classical Gauge 27 needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioids requirements intraoperatively
The investigators will document the required dose of opioids intraoperatively
Measured: 90 minutes
Pain score in the post-anesthesia care unit (PACU)
Pain score will be assessed regularly during the stay in the PACU using a pain scoring scale, where the score is interpreted from 0 to 10, in which 0 means no pain and 10 signifies very severe pain.
Measured: 120 minutes
Peri-operative complications
Peri-operative complications related to the caudal block procedure will be documented from the start of the procedure till the discharge from the post-anesthesia care unit.
Measured: 210 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start2 Jan 2021
- Primary completion20 Apr 2022
- Study completion20 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, omar ahmad ababneh, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691531
- Sponsor's protocol ID
- 4599/2020/67
- Status last verified
- Jan 2023
- First submitted
- 28 Dec 2020
- Last updated
- 25 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing the Invasiveness of Ultrasound Guided Caudal Block: A Randomized Controlled Trial Comparing Between 22-gauge and 27-guage Needles
- ClinicalTrials.gov ID
- NCT04691531
- Acronym / sponsor ID
- 4599/2020/67
- Conditions
- Anesthesia, Pain, Caudal Block, Pediatric Anesthesia, Abdominal Surgeries
- Keywords
- Caudal block, Ultrasound, Pediatric anesthesia, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 2 Jan 2021 (actual)
- Primary completion
- 20 Apr 2022 (actual)
- Study completion
- 20 Apr 2022 (actual)
- First posted
- 31 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.
Ultrasound (US) has facilitated the use of caudal block in children and visualization of the needle during insertion. This prospective clinical trial study compares between two different sizes of the used needles, in terms of success rate, number of punctures, detection of the US signs (visualization of the needle, dural displacement, turbulence, and distention), and complications in pediatrics aging between 6-36 months requiring elective lower abdominal and perineal surgeries.
Detailed description
Ultrasound (US) has facilitated the use of caudal block in children, allowing an initial assessment of the anatomy of the sacrum, including the relationship of the sacral hiatus to the dural sac ending. Real-time US allows visualization of the needle during insertion to reach the dural sac, and to see the turbulence and distention of the layers during injection of the local anesthetic drug.
This prospective clinical trial study compares between two different sizes of the used needles, in terms of success rate, number of punctures, detection of the US signs (visualization of the needle, dural displacement, turbulence, and distention), and complications in pediatrics aging between 6-36 months requiring elective lower abdominal and perineal surgeries.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group C | Experimental | Device: The use of classical Gauge 22 needleAfter induction of general anesthesia, patients will undergo caudal block by classical Gauge 22 needle under ultrasound guidance using a linear probe 5.5-12 MHz, and Bupivacaine 1 ml/kg of 0.25% will be injected. |
| Group S | Experimental | Device: The use of classical Gauge 27 needleAfter induction of general anesthesia, patients will undergo caudal block by Gauge 27 needle under ultrasound guidance using a linear probe 5.5-12 MHz, and Bupivacaine 1 ml/kg of 0.25% will be injected. |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age between 6 months and 36 months
- Undergoing elective lower abdominal or perineal surgeries
Key exclusion criteria (8 listed)
- Refusal of the legal guardian of the patient.
- Patients aging less than 6 months, or older than 36 months.
- Emergency surgeries.
- Coagulopathy.
- infection at the site of procedure.
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 |
|---|---|---|
| The use of classical Gauge 22 needleAfter induction of general anesthesia, patients will undergo caudal block by using classical Gauge 22 needle under ultrasound guidance using a linear probe 5.5-12 MHz. | Device | group C |
| The use of classical Gauge 27 needleAfter induction of general anesthesia, patients will undergo caudal block by using Gauge 27 needle under ultrasound guidance using a linear probe 5.5-12 MHz. | Device | Group S |
Primary outcome
Opioids requirements intraoperatively
Time frame: 90 minutes
The investigators will document the required dose of opioids intraoperatively
Pain score in the post-anesthesia care unit (PACU)
Time frame: 120 minutes
Pain score will be assessed regularly during the stay in the PACU using a pain scoring scale, where the score is interpreted from 0 to 10, in which 0 means no pain and 10 signifies very severe pain.
Peri-operative complications
Time frame: 210 minutes
Peri-operative complications related to the caudal block procedure will be documented from the start of the procedure till the discharge from the post-anesthesia care unit.
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 25 Jan 2023.
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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 The use of classical Gauge 22 needle and The use of classical Gauge 27 needle in people with Anesthesia and Pain, run by University of Jordan at 1 site in Jordan.
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 8 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 25 Jan 2023. 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 Jordan. 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?
Opioids requirements intraoperatively (time frame: 90 minutes). The study lists 3 primary outcomes in all. 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 25 Jan 2023.