Caudal Block for Postoperative AnalgesiaNCT04415905
Comparison of Optic Nerve Sheath Diameter in Children Receiving Caudal Block According to Anesthetic Agents: Total Intravenous Anesthesia vs. Volatile Anesthesia
A study testing Propofol and Sevoflurane in people with Caudal Block for Postoperative Analgesia, run by Yonsei University at 1 site in South Korea.
Trial summary
Caudal block is commonly used for postoperative analgesia in paediatric patients. A higher volume (1.5 ml/kg) of local anaesthetic for caudal block has been reported to not only increase the level of cranial spread but also provide better quality and longer duration of analgesia in comparison with the conventional… Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Caudal Block for Postoperative Analgesia
- What is being tested?
- Propofol and Sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Jun 2020to 2 Mar 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 3 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Among children undergoing urological surgery, patients, 36 to 72-months-old
- Body weight less than 20 kg (The limit on body weight is set because the maximum volume of local anaesthetic for caudal block in children is restricted to 30 ml.)
- Treatment plan for caudal block for analgesia, are enrolled.
Who cannot join
- Symptoms or signs of spinal anomalies or infection at the sacral region
- Coagulopathy
- Increased ICP
- Ophthalmic diseases
- History of increased ICP
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul
About this study
Caudal block is commonly used for postoperative analgesia in paediatric patients. A higher volume (1.5 ml/kg) of local anaesthetic for caudal block has been reported to not only increase the level of cranial spread but also provide better quality and longer duration of analgesia in comparison with the conventional volume (1.0 ml/kg). However, caudal block with a high volume of local anaesthetic can increase intracranial pressure (ICP). Previous studies have shown that propofol anesthesia lowers ICP when compared with volatile anesthesia. Therefore, this study was designed to test if propofol can reduce the magnitude of ICP increase following caudal block when compared with a volatile anesthetic, sevoflurane. There is increasing evidence that optic nerve sheath diameter (ONSD) measured by ultrasonography correlates with degree of ICP and is able to detect intracranial hypertension. Therefore, ONSD will be measured as a surrogate of ICP.
Read the detailed description
Equal number of patients are randomly assigned to the P or S group. The participants in the P and S group are anesthetized with propofol and sevoflurane, respectively. Irrespective of assigned group, all participants receive caudal block with 1.5 ml/kg of 0.15% ropivacaine (up to 30 ml per individual participant). All anesthetic procedures except for main anesthetic agent are the same in all participants. ONSD is measured at the following time points: before (T0), immediately after (T1), and 10 min (T2) and 30 min(T3) after caudal block. Two measurements of each optic nerve sheath are acquired in each eye. The mean value of the four measurements is considered as the ONSD at each time point.
- Conditions
- Caudal Block for Postoperative Analgesia
- Being tested
- Propofol, Sevoflurane
- Keywords
- Caudal block, Intracranial pressure, Propofol, Sevoflurane, Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
The participants in the group P are anesthetized with propofol
SevofluraneDrug
The participants in the group S are anesthetized with sevoflurane.
| Study group | Role | What they receive |
|---|---|---|
| group P | Experimental | The participants in the group P are anesthetized with propofol. Receives: Drug: Propofol |
| group S | Active comparator | The participants in the group S are anesthetized with sevoflurane. Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
ONSD
ONSD is a surrogate for ICP. ONSD was measured by transorbital sonography. Transorbital sonography is performed using a linear 6-13 Hz probe. After applying a thick layer of sterile coupling gel on the closed upper eyelid, the probe is placed gently without exerting pressure. Axial images of the orbit are acquired in the plane of the optic nerve, and ONSD is measured 3mm posterior to the optic nerve head as described previously.
Measured: before (T0) caudal block.
ONSD
ONSD is a surrogate for ICP. ONSD was measured by transorbital sonography. Transorbital sonography is performed using a linear 6-13 Hz probe. After applying a thick layer of sterile coupling gel on the closed upper eyelid, the probe is placed gently without exerting pressure. Axial images of the orbit are acquired in the plane of the optic nerve, and ONSD is measured 3mm posterior to the optic nerve head as described previously.
Measured: immediately after (T1) caudal block.
ONSD
ONSD is a surrogate for ICP. ONSD was measured by transorbital sonography. Transorbital sonography is performed using a linear 6-13 Hz probe. After applying a thick layer of sterile coupling gel on the closed upper eyelid, the probe is placed gently without exerting pressure. Axial images of the orbit are acquired in the plane of the optic nerve, and ONSD is measured 3mm posterior to the optic nerve head as described previously.
Measured: 10 minutes (T2) after caudal block.
ONSD
ONSD is a surrogate for ICP. ONSD was measured by transorbital sonography. Transorbital sonography is performed using a linear 6-13 Hz probe. After applying a thick layer of sterile coupling gel on the closed upper eyelid, the probe is placed gently without exerting pressure. Axial images of the orbit are acquired in the plane of the optic nerve, and ONSD is measured 3mm posterior to the optic nerve head as described previously.
Measured: 30 minutes (T3) after caudal block.
Secondary outcomes (28)
The variables affecting ICP : Heart rate (beats per minute)
Measured: before (T0) caudal block.
The variables affecting ICP : Heart rate (beats per minute)
Measured: immediately after (T1) caudal block.
The variables affecting ICP : Heart rate (beats per minute)
Measured: 10 minutes (T2) after caudal block.
The variables affecting ICP : Heart rate (beats per minute)
Measured: 30 minutes (T3) after caudal block.
The variables affecting ICP : Mean arterial pressure (mmHg)
Measured: before (T0) caudal block.
The variables affecting ICP : Mean arterial pressure (mmHg)
Measured: immediately after (T1) caudal block.
The variables affecting ICP : Mean arterial pressure (mmHg)
Measured: 10 minutes (T2) after caudal block.
The variables affecting ICP : Mean arterial pressure (mmHg)
Measured: 30 minutes (T3) after caudal block.
The variables affecting ICP : End-tidal carbon dioxide partial pressure (mmHg)
Measured: before (T0) caudal block.
The variables affecting ICP : End-tidal carbon dioxide partial pressure (mmHg)
Measured: immediately after (T1) caudal block.
The variables affecting ICP : End-tidal carbon dioxide partial pressure (mmHg)
Measured: 10 minutes (T2) after caudal block.
The variables affecting ICP : End-tidal carbon dioxide partial pressure (mmHg)
Measured: 30 minutes (T3) after caudal block.
The variables affecting ICP : End-tidal sevoflurane concentration (volume %)
Measured: before (T0) caudal block.
The variables affecting ICP : End-tidal sevoflurane concentration (volume %)
Measured: immediately after (T1) caudal block.
The variables affecting ICP : End-tidal sevoflurane concentration (volume %)
Measured: 10 minutes (T2) after caudal block.
The variables affecting ICP : End-tidal sevoflurane concentration (volume %)
Measured: 30 minutes (T3) after caudal block.
The variables affecting ICP : Estimated propofol effect-site concentration (μg/ml)
Measured: before (T0) caudal block.
The variables affecting ICP : Estimated propofol effect-site concentration (μg/ml)
Measured: immediately after (T1) caudal block.
The variables affecting ICP : Estimated propofol effect-site concentration (μg/ml)
Measured: 10 minutes (T2) after caudal block.
The variables affecting ICP : Estimated propofol effect-site concentration (μg/ml)
Measured: 30 minutes (T3) after caudal block.
The variables affecting ICP : Body temperature (℃)
Measured: before (T0) caudal block.
The variables affecting ICP : Body temperature (℃)
Measured: immediately after (T1) caudal block.
The variables affecting ICP : Body temperature (℃)
Measured: 10 minutes (T2) after caudal block.
The variables affecting ICP : Body temperature (℃)
Measured: 30 minutes (T3) after caudal block.
The variables affecting ICP : Peak inspiratory pressure (mmHg)
Measured: before (T0) caudal block.
The variables affecting ICP : Peak inspiratory pressure (mmHg)
Measured: immediately after (T1) caudal block.
The variables affecting ICP : Peak inspiratory pressure (mmHg)
Measured: 10 minutes (T2) after caudal block.
The variables affecting ICP : Peak inspiratory pressure (mmHg)
Measured: 30 minutes (T3) after caudal block.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start22 Jun 2020
- Primary completion2 Mar 2022
- Study completion2 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caudal Block for Postoperative AnalgesiaStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are 2 groups according to the type of main anesthetic agent. P group are anesthetized with propofol, so are S group with sevoflurane.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415905
- Sponsor's protocol ID
- 4-2020-0061
- Status last verified
- May 2022
- First submitted
- 28 May 2020
- Last updated
- 5 May 2022
- 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 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Optic Nerve Sheath Diameter in Children Receiving Caudal Block According to Anesthetic Agents: Total Intravenous Anesthesia vs. Volatile Anesthesia
- ClinicalTrials.gov ID
- NCT04415905
- Acronym / sponsor ID
- 4-2020-0061
- Conditions
- Caudal Block for Postoperative Analgesia
- Keywords
- Caudal block, Intracranial pressure, Propofol, Sevoflurane, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 22 Jun 2020 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 2 Mar 2022 (actual)
- First posted
- 4 Jun 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 commonly used for postoperative analgesia in paediatric patients. A higher volume (1.5 ml/kg) of local anaesthetic for caudal block has been reported to not only increase the level of cranial spread but also provide better quality and longer duration of analgesia in comparison with the conventional volume (1.0 ml/kg). However, caudal block with a high volume of local anaesthetic can increase intracranial pressure (ICP). Previous studies have shown that propofol anesthesia lowers ICP when compared with volatile anesthesia. Therefore, this study was designed to test if propofol can reduce the magnitude of ICP increase following caudal block when compared with a volatile anesthetic, sevoflurane. There is increasing evidence that optic nerve sheath diameter (ONSD) measured by ultrasonography correlates with degree of ICP and is able to detect intracranial hypertension. Therefore, ONSD will be measured as a surrogate of ICP.
Detailed description
Equal number of patients are randomly assigned to the P or S group. The participants in the P and S group are anesthetized with propofol and sevoflurane, respectively. Irrespective of assigned group, all participants receive caudal block with 1.5 ml/kg of 0.15% ropivacaine (up to 30 ml per individual participant). All anesthetic procedures except for main anesthetic agent are the same in all participants. ONSD is measured at the following time points: before (T0), immediately after (T1), and 10 min (T2) and 30 min(T3) after caudal block. Two measurements of each optic nerve sheath are acquired in each eye. The mean value of the four measurements is considered as the ONSD at each time point.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- There are 2 groups according to the type of main anesthetic agent. P group are anesthetized with propofol, so are S group with sevoflurane.
| Arm | Type | Receives |
|---|---|---|
| group P | Experimental | Drug: PropofolThe participants in the group P are anesthetized with propofol. |
| group S | Active comparator | Drug: SevofluraneThe participants in the group S are anesthetized with sevoflurane. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Among children undergoing urological surgery, patients, 36 to 72-months-old
- Body weight less than 20 kg (The limit on body weight is set because the maximum volume of local anaesthetic for caudal block in children is restricted to 30 ml.)
- Treatment plan for caudal block for analgesia, are enrolled.
Key exclusion criteria (5 listed)
- Symptoms or signs of spinal anomalies or infection at the sacral region
- Coagulopathy
- Increased ICP
- Ophthalmic diseases
- History of increased ICP
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 |
|---|---|---|
| PropofolThe participants in the group P are anesthetized with propofol | Drug | group P |
| SevofluraneThe participants in the group S are anesthetized with sevoflurane. | Drug | group S |
Primary outcome
ONSD
Time frame: before (T0) caudal block.
ONSD is a surrogate for ICP. ONSD was measured by transorbital sonography. Transorbital sonography is performed using a linear 6-13 Hz probe. After applying a thick layer of sterile coupling gel on the closed upper eyelid, the probe is placed gently without exerting pressure. Axial images of the orbit are acquired in the plane of the optic nerve, and ONSD is measured 3mm posterior to the optic nerve head as described previously.
ONSD
Time frame: immediately after (T1) caudal block.
ONSD is a surrogate for ICP. ONSD was measured by transorbital sonography. Transorbital sonography is performed using a linear 6-13 Hz probe. After applying a thick layer of sterile coupling gel on the closed upper eyelid, the probe is placed gently without exerting pressure. Axial images of the orbit are acquired in the plane of the optic nerve, and ONSD is measured 3mm posterior to the optic nerve head as described previously.
ONSD
Time frame: 10 minutes (T2) after caudal block.
ONSD is a surrogate for ICP. ONSD was measured by transorbital sonography. Transorbital sonography is performed using a linear 6-13 Hz probe. After applying a thick layer of sterile coupling gel on the closed upper eyelid, the probe is placed gently without exerting pressure. Axial images of the orbit are acquired in the plane of the optic nerve, and ONSD is measured 3mm posterior to the optic nerve head as described previously.
ONSD
Time frame: 30 minutes (T3) after caudal block.
ONSD is a surrogate for ICP. ONSD was measured by transorbital sonography. Transorbital sonography is performed using a linear 6-13 Hz probe. After applying a thick layer of sterile coupling gel on the closed upper eyelid, the probe is placed gently without exerting pressure. Axial images of the orbit are acquired in the plane of the optic nerve, and ONSD is measured 3mm posterior to the optic nerve head as described previously.
28 secondary outcomes
The variables affecting ICP : Heart rate (beats per minute)
Time frame: before (T0) caudal block.
The variables affecting ICP : Heart rate (beats per minute)
Time frame: immediately after (T1) caudal block.
The variables affecting ICP : Heart rate (beats per minute)
Time frame: 10 minutes (T2) after caudal block.
The variables affecting ICP : Heart rate (beats per minute)
Time frame: 30 minutes (T3) after caudal block.
The variables affecting ICP : Mean arterial pressure (mmHg)
Time frame: before (T0) caudal block.
The variables affecting ICP : Mean arterial pressure (mmHg)
Time frame: immediately after (T1) caudal block.
The variables affecting ICP : Mean arterial pressure (mmHg)
Time frame: 10 minutes (T2) after caudal block.
The variables affecting ICP : Mean arterial pressure (mmHg)
Time frame: 30 minutes (T3) after caudal block.
The variables affecting ICP : End-tidal carbon dioxide partial pressure (mmHg)
Time frame: before (T0) caudal block.
The variables affecting ICP : End-tidal carbon dioxide partial pressure (mmHg)
Time frame: immediately after (T1) caudal block.
The variables affecting ICP : End-tidal carbon dioxide partial pressure (mmHg)
Time frame: 10 minutes (T2) after caudal block.
The variables affecting ICP : End-tidal carbon dioxide partial pressure (mmHg)
Time frame: 30 minutes (T3) after caudal block.
The variables affecting ICP : End-tidal sevoflurane concentration (volume %)
Time frame: before (T0) caudal block.
The variables affecting ICP : End-tidal sevoflurane concentration (volume %)
Time frame: immediately after (T1) caudal block.
The variables affecting ICP : End-tidal sevoflurane concentration (volume %)
Time frame: 10 minutes (T2) after caudal block.
The variables affecting ICP : End-tidal sevoflurane concentration (volume %)
Time frame: 30 minutes (T3) after caudal block.
The variables affecting ICP : Estimated propofol effect-site concentration (μg/ml)
Time frame: before (T0) caudal block.
The variables affecting ICP : Estimated propofol effect-site concentration (μg/ml)
Time frame: immediately after (T1) caudal block.
The variables affecting ICP : Estimated propofol effect-site concentration (μg/ml)
Time frame: 10 minutes (T2) after caudal block.
The variables affecting ICP : Estimated propofol effect-site concentration (μg/ml)
Time frame: 30 minutes (T3) after caudal block.
The variables affecting ICP : Body temperature (℃)
Time frame: before (T0) caudal block.
The variables affecting ICP : Body temperature (℃)
Time frame: immediately after (T1) caudal block.
The variables affecting ICP : Body temperature (℃)
Time frame: 10 minutes (T2) after caudal block.
The variables affecting ICP : Body temperature (℃)
Time frame: 30 minutes (T3) after caudal block.
The variables affecting ICP : Peak inspiratory pressure (mmHg)
Time frame: before (T0) caudal block.
The variables affecting ICP : Peak inspiratory pressure (mmHg)
Time frame: immediately after (T1) caudal block.
The variables affecting ICP : Peak inspiratory pressure (mmHg)
Time frame: 10 minutes (T2) after caudal block.
The variables affecting ICP : Peak inspiratory pressure (mmHg)
Time frame: 30 minutes (T3) after caudal block.
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 5 May 2022.
- 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 Propofol and Sevoflurane in people with Caudal Block for Postoperative Analgesia, run by Yonsei University at 1 site in South Korea.
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 3 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: finished, as of the sponsor's last update on 5 May 2022. 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 South Korea. 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?
ONSD (time frame: before (T0) caudal block.). The study lists 4 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 5 May 2022.