- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03427437
Ultrasound-Guided Versus Conventional Method for Caudal Block
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Konya, Turkey
- Baskent University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ASA (American Society of Anesthesiologist) I children aged between 6 months and 8 years old who underwent elective hypospadias, circumcision and both surgery
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Conventional Group
Caudal block was performed by conventional method with %0,25 bupivacaine plus 1/200.000
adrenalin
|
caudal block was performed by conventional and ultrasound method with %0,25 bupivacaine + 1/200000 adrenalin
Other Names:
caudal block was performed by conventional and ultrasound method with %0,25 bupivacaine + 1/200000 adrenalin
Other Names:
|
ACTIVE_COMPARATOR: Ultrasound Group
Caudal block was performed by ultrasound method with %0,25 bupivacaine plus 1/200.000
adrenalin
|
caudal block was performed by conventional and ultrasound method with %0,25 bupivacaine + 1/200000 adrenalin
Other Names:
caudal block was performed by conventional and ultrasound method with %0,25 bupivacaine + 1/200000 adrenalin
Other Names:
caudal block was performed by ultrasound method
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
success rate of block
Time Frame: Intraoperative period
|
absence of significant motor movements following surgical induction or aberrations in heart and or respiratory rates
|
Intraoperative period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
block performing time
Time Frame: Intraoperative first hour
|
The block time was defined as the period between the insertion of the needle and termination of local anesthetic administration
|
Intraoperative first hour
|
first puncture success rate
Time Frame: Intraoperative first hour
|
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.
|
Intraoperative first hour
|
complications
Time Frame: Intraoperative first hour
|
situations such as vascular puncture, bone contact, subcutaneous injection encountered, when the caudal block was performed,
|
Intraoperative first hour
|
age and weight encountered complications
Time Frame: Intraoperative first hour
|
below which age and weight
|
Intraoperative first hour
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Omer Karaca, MD, Baskent University
Publications and helpful links
General 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.
- Ahiskalioglu 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Anesthetics, Local
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Bupivacaine
- Epinephrine
- Racepinephrine
- Epinephryl borate
Other Study ID Numbers
- KA 16/354
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ultrasound Therapy; Complications
-
Assiut UniversityRecruitingUltrasound Therapy; ComplicationsEgypt
-
National Cancer Institute, EgyptCompletedUltrasound Therapy; ComplicationsEgypt
-
Ataturk UniversityCompletedUltrasound Therapy; ComplicationsTurkey
-
Tongji HospitalRecruitingUltrasound Therapy; ComplicationsChina
-
Rongqin ZhengNot yet recruiting
-
National Taiwan University HospitalCompletedUltrasound Therapy; ComplicationsTaiwan
-
Assiut UniversityNot yet recruitingUltrasound Therapy; Complications
-
Cairo UniversityNot yet recruitingUltrasound Therapy; Complications
-
Carilion ClinicRecruitingUltrasound Therapy; ComplicationsUnited States
-
Massachusetts General HospitalNot yet recruitingUltrasound Therapy; Complications
Clinical Trials on Bupivacaine
-
Hospital Civil de GuadalajaraRecruitingEffect of Subarachnoid Hyperbaric Bupivacaine in Obese Pregnant Patients Undergoing Cesarean SectionAnesthesia | Obstetric Anesthesia ProblemsMexico
-
Hospital Civil de GuadalajaraCompletedAnesthesia, ObstetricalMexico
-
DurectNycomedCompletedPostoperative PainAustria, Germany, Latvia, Poland, Sweden
-
DurectNycomedCompletedPostoperative PainFrance, Germany, Hungary, Latvia, Sweden, United Kingdom
-
Seoul National University HospitalUnknownAnesthesia, Spinal [E03.155.086.331] | Operating Tables [E07.325.662]Korea, Republic of
-
Indiana UniversityCompletedPain, Postoperative | Acute Pain | ThoracicUnited States
-
Coordinación de Investigación en Salud, MexicoInstituto Mexicano del Seguro SocialCompletedObstetric PainMexico
-
Vanderbilt University Medical CenterCompletedAnesthesia | Breast Reconstruction | Transverse Abdominis Plane BlockUnited States
-
Indiana UniversityCompleted
-
University of Texas Southwestern Medical CenterCompleted