Ultrasound Therapy; ComplicationsNCT03337191
Ultrasound-Guided Versus Conventional Injection for Caudal Block
A study testing Levobupivacaine, Morphine Sulfate and Ultrasound in people with Ultrasound Therapy; Complications, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Caudal epidural block has been widely used, especially in pediatric surgery, to provide 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 5 to 12 years, men only
- Conditions the study is for
- Ultrasound Therapy; Complications
- What is being tested?
- Levobupivacaine, Morphine Sulfate and Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2016to 1 Sep 2016
- 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 5 to 12 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- American Society of Anesthesiologist's physiologic state I-II patients undergoing phimosis and circumcision surgery
Who cannot join
- children with 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 Injection for Caudal Block in Children
Caudal epidural block has been widely used, especially in pediatric surgery, to provide 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. Ultrasonography is helpful for visualization of the sacral hiatus, sacrococcygeal ligament, duramater, epidural space and the distribution of the local anesthetic agent within the epidural space. Therefore, this significantly increases the block success.
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.
- Conditions
- Ultrasound Therapy; Complications
- Being tested
- Levobupivacaine, Morphine Sulfate, Ultrasound
- Keywords
- ultrasound guided caudal injection, sacral hiatus, sacral canal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevobupivacaineDrug
Also called ultrasound guided caudal block
% 0,125 levobupivacaine
Morphine SulfateDrug
10 mq/kg morphine sulfate
UltrasoundDevice
Ultrasound guided caudal block
| Study group | Role | What they receive |
|---|---|---|
| ultrasound guided caudal block | Active comparator | Caudal block was performed by ultrasound guided with %0,125 levobupivacaine + 10 mq/kg morphine Receives: Drug: Levobupivacaine; Drug: Morphine Sulfate; Device: Ultrasound |
| conventional caudal block | Active comparator | Caudal block was performed by conventional method with %0,125 levobupivacaine + 10 mq/kg morphine Receives: Drug: Levobupivacaine; Drug: Morphine Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate of block
A successful block was defined as absence of significant motor movements following surgical induction or heart and respiratory rates increasing not more than 20% of the basal levels.
Measured: Intraoperative first hour
Secondary outcomes (2)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start1 Jan 2016
- Primary completion1 Jul 2016
- Study completion1 Sep 2016
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Ahiskalioglu, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03337191
- Sponsor's protocol ID
- Caudal Ataturk Uni
- Status last verified
- Nov 2017
- First submitted
- 6 Nov 2017
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dostbil A, Gursac Celik M, Aksoy M, Ahiskalioglu A, Celik EC, Alici HA, Ozbey I. The effects of different doses of caudal morphine with levobupivacaine on postoperative vomiting and quality of analgesia after circumcision. Anaesth Intensive Care. 2014 Mar;42(2):234-8. doi: 10.1177/0310057X1404200211.
PubMed 24580390Wang 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 23278906
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Versus Conventional Injection for Caudal Block in Children
- ClinicalTrials.gov ID
- NCT03337191
- Acronym / sponsor ID
- Caudal Ataturk Uni
- Conditions
- Ultrasound Therapy; Complications
- Keywords
- ultrasound guided caudal injection, sacral hiatus, sacral canal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 1 Sep 2016 (actual)
- First posted
- 8 Nov 2017 (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 provide 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. Ultrasonography is helpful for visualization of the sacral hiatus, sacrococcygeal ligament, duramater, epidural space and the distribution of the local anesthetic agent within the epidural space. Therefore, this significantly increases the block success.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrasound guided caudal block | Active comparator | Drug: Levobupivacaine, Drug: Morphine Sulfate, Device: UltrasoundCaudal block was performed by ultrasound guided with %0,125 levobupivacaine + 10 mq/kg morphine |
| conventional caudal block | Active comparator | Drug: Levobupivacaine, Drug: Morphine SulfateCaudal block was performed by conventional method with %0,125 levobupivacaine + 10 mq/kg morphine |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- American Society of Anesthesiologist's physiologic state I-II patients undergoing phimosis and circumcision surgery
Key exclusion criteria (6 listed)
- children with severe systemic disease
- previous neurological or spinal disorder,
- coagulation anomaly
- allergy against local anesthetics
- local infection at block site or
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 |
|---|---|---|
| LevobupivacaineAlso: ultrasound guided caudal block% 0,125 levobupivacaine | Drug | conventional caudal block, ultrasound guided caudal block |
| Morphine Sulfate10 mq/kg morphine sulfate | Drug | conventional caudal block, ultrasound guided caudal block |
| UltrasoundUltrasound guided caudal block | Device | ultrasound guided caudal block |
Primary outcome
success rate of block
Time frame: Intraoperative first hour
A successful block was defined as absence of significant motor movements following surgical induction or heart and respiratory rates increasing not more than 20% of the basal levels.
2 secondary outcomes
block performing time
Time frame: Intraoperative first hour
first puncture success rate
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 Nov 2017.
- Background: PubMed 24580390Dostbil A, Gursac Celik M, Aksoy M, Ahiskalioglu A, Celik EC, Alici HA, Ozbey I. The effects of different doses of caudal morphine with levobupivacaine on postoperative vomiting and quality of analgesia after circumcision. Anaesth Intensive Care. 2014 Mar;42(2):234-8. doi: 10.1177/0310057X1404200211.
- Background: 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.
- 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 Levobupivacaine, Morphine Sulfate and Ultrasound in people with Ultrasound Therapy; Complications, 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 1 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 9 Nov 2017. 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 first hour). 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 NCT03337191, 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 Nov 2017.