Ultrasound Therapy; ComplicationsNCT03427437
Ultrasound-Guided Versus Conventional Method for Caudal Block
A study testing Bupivacaine, Adrenalin and Ultrasound in people with Ultrasound Therapy; Complications, run by Omer Karaca at 1 site in Turkey (Türkiye).
Trial summary
Caudal epidural block has been widely used, especially in pediatric surgery, to supply intraoperative and postoperative analgesia by affecting the region between T10 and S5 dermatomes in surgeries below the umbilical level. Read more about this study
- Who is it for?
- Ages 6 months to 8 years, men only
- Conditions the study is for
- Ultrasound Therapy; Complications
- What is being tested?
- Bupivacaine, Adrenalin and Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2017to 1 Jan 2018
- 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 8 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- ASA (American Society of Anesthesiologist) I children aged between 6 months and 8 years old who underwent elective hypospadias, circumcision and both surgery
Who cannot join
- Severe systemic disease, previous neurological or spinal disorder, coagulation anomaly, allergy against local anesthetics, local infection at block site or with a history of premature birth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-Guided Versus Conventional Method for Caudal Block in Children
Caudal epidural block has been widely used, especially in pediatric surgery, to supply intraoperative and postoperative analgesia by affecting the region between T10 and S5 dermatomes in surgeries below the umbilical level.
In conventional single-shot caudal block, the needle is inserted through the skin with a 60-80 degrees angle, until the sacrococcygeal ligament is passed through. Then the angle of the needle is decreased to 20-30 degrees and inserted further for an additional 2-3 mm, entering into the sacral canal.There is a risk of dural or vascular puncture when the needle is passing through sacral canal. Other complications are the soft tissue bulging, intraosseous injections and systemic toxicity.
Read more
Many anatomical variations have been reported for sacral hiatus and sacral cornua. Therefore, the success rate of the classic caudal epidural anesthesia method in pediatric patients has been reported to be about 75%.
With the usage of ultrasonography in regional anesthesia, many advantages have been reported. In particular ultrasonography under longitudinal image is helpful for visualization of the sacral hiatus, sacrococcygeal ligament, duramater, epidural space and the distribution of the local anesthetic agent Therefore, this significantly increases the block success and visualization of where local anesthetic is injected.
The primary aim of this study was compare the success rate of ultrasound guided sacral hiatus injection and conventional sacral canal injection. Secondary objectives are; block performing time, number of needle puncture, success at first puncture and complication rate. However age and weight encountered wtih these complications are registered.
Read the detailed description
The caudal block was performed in Group C by via conventional methods. The sacral cornus and the sacral hiatus were palpated. After sterilization of the region, a 22- gauge caudal needle was inserted into the skin with at a 60-80 degree angle and until the sacrococcygeal ligament was passed punctured, as determined with by a "popping sensation." feeling (puncture of the sacrococcygeal ligament). Then, the angle of the needle was then reduced to 20-30 degrees and inserted further for an additional 2-3mm, entering into the sacral canal. After verifingverifying the absence of any blood or cerebrospinal fluid in the aspiration, a test dose of 0.1 ml/kg of local anesthetic (LA) with adrenalin at a ratio of 1: 200000 was injected under hemodynamic and ECG monitoring. Following a negative test dose, the rest of the LA was slowly injected slowly over 1 min. In the case of the needle touching the bony tissue, blood aspiration, or bulging into of the subcutaneous tissue, the angle of the needle was changed and the intervention was repeated.
The caudal block was performed by via ultrasound guided ultrasound guidance in Group U. After sterilization of the region and using ultrasound guidanceUSG with a sterile plastic cover and gel, the sacral hiatus was visualized via an out-of-plane technique at the level of the sacral cornus at the out of plane via the lineerlinear transducer of an M-Turbo ultrasound machine (TM; Fujifilm SonoSite Inc., (Washington, WA, United StatesUSA) ultrasound machine at 13 MHz, and the, depth and gain was adjusted to for optimal visual quality. The ultrasound ultrasound transducer was first placed transversely at the midlain midline to obtain the transvers view of the two cornua, the sacrococcygeal ligament, the sacral bone, and the sacral hiatus. At this level, the ultrasound ultrasound transducer was rotated 90 degrees to obtain the longitudinal view of the sacrococcygeal ligamantligament and sacral hiatus, and was then placed between the two cornua. A 22- gauge caudal needle was advanced toward the upper third of the sacrococcygeal ligament. The needle advancement was terminated right after penetrating the sacrococcygeal ligament. At this level, after confirming the absence of any blood or cerebrospinal fluid in the aspiration and a negative test dose, the rest of the LA was injected over 1 min under while observing the ultrasound ultrasound longitudinal image
- Conditions
- Ultrasound Therapy; Complications
- Being tested
- Bupivacaine, Adrenalin, Ultrasound
- Keywords
- sacral canal, sacral hiatus, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Bustesin,Vem Drug, Ankara, Turkey
caudal block was performed by conventional and ultrasound method with %0,25 bupivacaine + 1/200000 adrenalin
AdrenalinDrug
Also called Adrenalin 0.5 mg, Osel Drug, Istanbul, Turkey
caudal block was performed by conventional and ultrasound method with %0,25 bupivacaine + 1/200000 adrenalin
UltrasoundDevice
Also called Sonosite M Turbo, USA
caudal block was performed by ultrasound method
| Study group | Role | What they receive |
|---|---|---|
| Conventional Group | Active comparator | Caudal block was performed by conventional method with %0,25 bupivacaine plus 1/200.000 adrenalin Receives: Drug: Bupivacaine; Drug: Adrenalin |
| Ultrasound Group | Active comparator | Caudal block was performed by ultrasound method with %0,25 bupivacaine plus 1/200.000 adrenalin Receives: Drug: Bupivacaine; Drug: Adrenalin; Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate of block
absence of significant motor movements following surgical induction or aberrations in heart and or respiratory rates
Measured: Intraoperative period
Secondary outcomes (4)
block performing time
The block time was defined as the period between the insertion of the needle and termination of local anesthetic administration
Measured: Intraoperative first hour
first puncture success rate
The first puncture success rate was defined as reaching the sacral canal or sacral hiatus with a single-needle orientation on the first puncture without any withdrawal from the skin.
Measured: Intraoperative first hour
complications
situations such as vascular puncture, bone contact, subcutaneous injection encountered, when the caudal block was performed,
Measured: Intraoperative first hour
age and weight encountered complications
below which age and weight
Measured: Intraoperative first hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start1 Feb 2017
- Primary completion1 Nov 2017
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ultrasound Therapy; ComplicationsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omer Karaca
- Sponsor type
- University, hospital or other
- Collaborators
- Baskent University
- Responsible party
- Sponsor-investigator, Omer Karaca, Baskent University
- Investigators
- Omer Karaca, MD, Principal investigator, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427437
- Sponsor's protocol ID
- KA 16/354
- Status last verified
- Feb 2018
- First submitted
- 23 Jan 2018
- Last updated
- 9 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang LZ, Hu XX, Zhang YF, Chang XY. A randomized comparison of caudal block by sacral hiatus injection under ultrasound guidance with traditional sacral canal injection in children. Paediatr Anaesth. 2013 May;23(5):395-400. doi: 10.1111/pan.12104. Epub 2012 Dec 29.
PubMed 23278906Ahiskalioglu A, Yayik AM, Ahiskalioglu EO, Ekinci M, Golboyu BE, Celik EC, Alici HA, Oral A, Demirdogen SO. Ultrasound-guided versus conventional injection for caudal block in children: A prospective randomized clinical study. J Clin Anesth. 2018 Feb;44:91-96. doi: 10.1016/j.jclinane.2017.11.011. Epub 2017 Nov 21.
PubMed 29161549
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Versus Conventional Method for Caudal Block in Children
- ClinicalTrials.gov ID
- NCT03427437
- Acronym / sponsor ID
- KA 16/354
- Conditions
- Ultrasound Therapy; Complications
- Keywords
- sacral canal, sacral hiatus, ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Omer KaracaUniversity, hospital or other
- Collaborators
- Baskent University
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 9 Feb 2018 (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 widely used, especially in pediatric surgery, to supply intraoperative and postoperative analgesia by affecting the region between T10 and S5 dermatomes in surgeries below the umbilical level.
In conventional single-shot caudal block, the needle is inserted through the skin with a 60-80 degrees angle, until the sacrococcygeal ligament is passed through. Then the angle of the needle is decreased to 20-30 degrees and inserted further for an additional 2-3 mm, entering into the sacral canal.There is a risk of dural or vascular puncture when the needle is passing through sacral canal. Other complications are the soft tissue bulging, intraosseous injections and systemic toxicity.
Many anatomical variations have been reported for sacral hiatus and sacral cornua. Therefore, the success rate of the classic caudal epidural anesthesia method in pediatric patients has been reported to be about 75%.
With the usage of ultrasonography in regional anesthesia, many advantages have been reported. In particular ultrasonography under longitudinal image is helpful for visualization of the sacral hiatus, sacrococcygeal ligament, duramater, epidural space and the distribution of the local anesthetic agent Therefore, this significantly increases the block success and visualization of where local anesthetic is injected.
The primary aim of this study was compare the success rate of ultrasound guided sacral hiatus injection and conventional sacral canal injection. Secondary objectives are; block performing time, number of needle puncture, success at first puncture and complication rate. However age and weight encountered wtih these complications are registered.
Detailed description
The caudal block was performed in Group C by via conventional methods. The sacral cornus and the sacral hiatus were palpated. After sterilization of the region, a 22- gauge caudal needle was inserted into the skin with at a 60-80 degree angle and until the sacrococcygeal ligament was passed punctured, as determined with by a "popping sensation." feeling (puncture of the sacrococcygeal ligament). Then, the angle of the needle was then reduced to 20-30 degrees and inserted further for an additional 2-3mm, entering into the sacral canal. After verifingverifying the absence of any blood or cerebrospinal fluid in the aspiration, a test dose of 0.1 ml/kg of local anesthetic (LA) with adrenalin at a ratio of 1: 200000 was injected under hemodynamic and ECG monitoring. Following a negative test dose, the rest of the LA was slowly injected slowly over 1 min. In the case of the needle touching the bony tissue, blood aspiration, or bulging into of the subcutaneous tissue, the angle of the needle was changed and the intervention was repeated.
The caudal block was performed by via ultrasound guided ultrasound guidance in Group U. After sterilization of the region and using ultrasound guidanceUSG with a sterile plastic cover and gel, the sacral hiatus was visualized via an out-of-plane technique at the level of the sacral cornus at the out of plane via the lineerlinear transducer of an M-Turbo ultrasound machine (TM; Fujifilm SonoSite Inc., (Washington, WA, United StatesUSA) ultrasound machine at 13 MHz, and the, depth and gain was adjusted to for optimal visual quality. The ultrasound ultrasound transducer was first placed transversely at the midlain midline to obtain the transvers view of the two cornua, the sacrococcygeal ligament, the sacral bone, and the sacral hiatus. At this level, the ultrasound ultrasound transducer was rotated 90 degrees to obtain the longitudinal view of the sacrococcygeal ligamantligament and sacral hiatus, and was then placed between the two cornua. A 22- gauge caudal needle was advanced toward the upper third of the sacrococcygeal ligament. The needle advancement was terminated right after penetrating the sacrococcygeal ligament. At this level, after confirming the absence of any blood or cerebrospinal fluid in the aspiration and a negative test dose, the rest of the LA was injected over 1 min under while observing the ultrasound ultrasound longitudinal image
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Group | Active comparator | Drug: Bupivacaine, Drug: AdrenalinCaudal block was performed by conventional method with %0,25 bupivacaine plus 1/200.000 adrenalin |
| Ultrasound Group | Active comparator | Drug: Bupivacaine, Drug: Adrenalin, Device: UltrasoundCaudal block was performed by ultrasound method with %0,25 bupivacaine plus 1/200.000 adrenalin |
Who may qualify
- Ages
- 6 months to 8 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- ASA (American Society of Anesthesiologist) I children aged between 6 months and 8 years old who underwent elective hypospadias, circumcision and both surgery
Key exclusion criteria (1 listed)
- Severe systemic disease, previous neurological or spinal disorder, coagulation anomaly, allergy against local anesthetics, local infection at block site or with a history of premature 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 |
|---|---|---|
| BupivacaineAlso: Bustesin,Vem Drug, Ankara, Turkeycaudal block was performed by conventional and ultrasound method with %0,25 bupivacaine + 1/200000 adrenalin | Drug | Conventional Group, Ultrasound Group |
| AdrenalinAlso: Adrenalin 0.5 mg, Osel Drug, Istanbul, Turkeycaudal block was performed by conventional and ultrasound method with %0,25 bupivacaine + 1/200000 adrenalin | Drug | Conventional Group, Ultrasound Group |
| UltrasoundAlso: Sonosite M Turbo, USAcaudal block was performed by ultrasound method | Device | Ultrasound Group |
Primary outcome
success rate of block
Time frame: Intraoperative period
absence of significant motor movements following surgical induction or aberrations in heart and or respiratory rates
4 secondary outcomes
block performing time
Time frame: Intraoperative first hour
first puncture success rate
Time frame: Intraoperative first hour
complications
Time frame: Intraoperative first hour
age and weight encountered complications
Time frame: Intraoperative first hour
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 9 Feb 2018.
- Results publication: PubMed 23278906Wang LZ, Hu XX, Zhang YF, Chang XY. A randomized comparison of caudal block by sacral hiatus injection under ultrasound guidance with traditional sacral canal injection in children. Paediatr Anaesth. 2013 May;23(5):395-400. doi: 10.1111/pan.12104. Epub 2012 Dec 29.
- Results publication: PubMed 29161549Ahiskalioglu A, Yayik AM, Ahiskalioglu EO, Ekinci M, Golboyu BE, Celik EC, Alici HA, Oral A, Demirdogen SO. Ultrasound-guided versus conventional injection for caudal block in children: A prospective randomized clinical study. J Clin Anesth. 2018 Feb;44:91-96. doi: 10.1016/j.jclinane.2017.11.011. Epub 2017 Nov 21.
- Individual participant dataSharing planned: No
Related trials for Ultrasound Therapy; Complications
Not yet recruiting
Low-Dose Norepinephrine With Conservative Fluid Therapy in Hepatobiliary Surgery
Postoperative Complications, Pulmonary Complication
Not yet recruiting
Structured Hemodynamic Assessment to Guide Care After Cardiac Surgery
Cardiac Surgical Procedures, Hemodynamics
Recruiting
Effect of Alcohol Sclerotherapy on Pelvic Pain and Quality of Life in Women With Ovarian Endometriosis
Endometrioma, Ultrasound Therapy; Complications
Not yet recruiting
High Intensity Focused Ultrasound (HIFU) Ablation for Treatment of Prostate Tissue in Bladder Outlet Obstruction
Bladder Outlet Obstruction, BPH
Recruiting
Fluid Balance Guided by Modified Venous Excess Ultrasonography Versus Standard Care in Patients With Acute Kidney Injury Receiving Continuous Renal Replacement Therapy
AKI - Acute Kidney Injury, Fluid Balance
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.
Omer Karaca, MD principal investigator
Baskent University
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, Adrenalin and Ultrasound in people with Ultrasound Therapy; Complications, run by Omer Karaca 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 1 inclusion and 1 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 9 Feb 2018. 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?
success rate of block (time frame: Intraoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03427437, which also lists 2 linked publications.
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 9 Feb 2018.