Postoperative PainNCT05216211
The Effect of Caudal Block on Optic Nerve Sheath Diameter in Pediatric Patients
A study testing Bupivacaine Hydrochloride in people with Postoperative Pain and Intracranial Hypertension, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Caudal epidural block has been a widely used regional anesthesia method, especially in pediatric surgery, to provide intraoperative and postoperative analgesia. Studies on non-invasive methods used for intracranial pressure measurement have shown that optic nerve sheath diameter is related to intracranial pressure. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Postoperative Pain, Intracranial Hypertension
- What is being tested?
- Bupivacaine Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Dec 2021to 30 Oct 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 1 year to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- circumcision,
- inguinal hernia,
- undescended testis,
- hydrocele operation
Who cannot join
- neurological or spinal anomaly,
- coagulopathy
- allergy to local anesthetics,
- local infection in the area to be intervention,
- with increased intracranial pressure
- children with any ophthalmic pathology
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ataturk University School of Medicine
Erzurum, Yakutiye, 25100
About this study
Caudal epidural block has been a widely used regional anesthesia method, especially in pediatric surgery, to provide intraoperative and postoperative analgesia. Studies on non-invasive methods used for intracranial pressure measurement have shown that optic nerve sheath diameter is related to intracranial pressure. Optic nerve sheath diameter measurement has high diagnostic accuracy for detecting increased intracranial pressure in children. The aim of the study is to investigate the effect of the caudal block on optic nerve sheath diameter in pediatric patients.
- Conditions
- Postoperative Pain, Intracranial Hypertension
- Being tested
- Bupivacaine Hydrochloride
- Medical subject headings
- Pain, Postoperative, Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine HydrochlorideDrug
1 ml / kg, % 0.25 bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Group Caudal | Active comparator | Caudal block with 1 ml / kg, % 0.25 bupivacaine Receives: Drug: Bupivacaine Hydrochloride |
| Group Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic Nerve Diameter
Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes
Measured: First minute
Optic Nerve Diameter
Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes
Measured: 5th minutes
Optic Nerve Diameter
Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes
Measured: 15th minutes
Optic Nerve Diameter
Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes
Measured: 30th minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start9 Dec 2021
- Primary completion1 Sep 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Murat Yayik, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05216211
- Sponsor's protocol ID
- Optic nerve Caudal
- Status last verified
- Dec 2022
- First submitted
- 9 Dec 2021
- Last updated
- 23 Dec 2022
- 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 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Caudal Block on Optic Nerve Sheath Diameter in Pediatric Patients
- ClinicalTrials.gov ID
- NCT05216211
- Acronym / sponsor ID
- Optic nerve Caudal
- Conditions
- Postoperative Pain, Intracranial Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 31 Jan 2022 (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 epidural block has been a widely used regional anesthesia method, especially in pediatric surgery, to provide intraoperative and postoperative analgesia. Studies on non-invasive methods used for intracranial pressure measurement have shown that optic nerve sheath diameter is related to intracranial pressure. Optic nerve sheath diameter measurement has high diagnostic accuracy for detecting increased intracranial pressure in children. The aim of the study is to investigate the effect of the caudal block on optic nerve sheath diameter in pediatric patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Caudal | Active comparator | Drug: Bupivacaine HydrochlorideCaudal block with 1 ml / kg, % 0.25 bupivacaine |
| Group Control | No intervention | –No intervention |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- circumcision,
- inguinal hernia,
- undescended testis,
- hydrocele operation
Key exclusion criteria (6 listed)
- neurological or spinal anomaly,
- coagulopathy
- allergy to local anesthetics,
- local infection in the area to be intervention,
- with increased intracranial pressure
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 |
|---|---|---|
| Bupivacaine Hydrochloride1 ml / kg, % 0.25 bupivacaine | Drug | Group Caudal |
Primary outcome
Optic Nerve Diameter
Time frame: First minute
Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes
Optic Nerve Diameter
Time frame: 5th minutes
Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes
Optic Nerve Diameter
Time frame: 15th minutes
Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes
Optic Nerve Diameter
Time frame: 30th minutes
Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes
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 23 Dec 2022.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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 Bupivacaine Hydrochloride in people with Postoperative Pain and Intracranial Hypertension, run by Ataturk 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 4 inclusion and 6 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 23 Dec 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 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?
Optic Nerve Diameter (time frame: First minute). 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 23 Dec 2022.