Ultrasound-Guided Versus Conventional Method for Caudal Block

Ultrasound Therapy; Complications Clinical Trial

Official title:

Ultrasound-Guided Versus Conventional Method for Caudal Block in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03427437
• Other study ID #: KA 16/354
• Status: Completed
• Phase: N/A
• First received: January 23, 2018
• Last updated: February 8, 2018
• Start date: February 1, 2017
• Est. completion date: January 1, 2018

Study information

• Verified date: February 2018
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. completion date: January 1, 2018
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 6 Months to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Ultrasound Therapy; Complications

Intervention

Drug:
• Bupivacaine
caudal block was performed by conventional and ultrasound method with %0,25 bupivacaine + 1/200000 adrenalin
• Adrenalin
caudal block was performed by conventional and ultrasound method with %0,25 bupivacaine + 1/200000 adrenalin

Device:
• Ultrasound
caudal block was performed by ultrasound method

Locations

Country	Name	City	State
Turkey	Baskent University	Konya

Sponsors (2)

Lead Sponsor	Collaborator
Omer Karaca	Baskent University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Ahiskalioglu A, Yayik AM, Ahiskalioglu EO, Ekinci M, Gölboyu 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;44:9 — View Citation

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 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	success rate of block	absence of significant motor movements following surgical induction or aberrations in heart and or respiratory rates	Intraoperative period
Secondary	block performing time	The block time was defined as the period between the insertion of the needle and termination of local anesthetic administration	Intraoperative first hour
Secondary	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.	Intraoperative first hour
Secondary	complications	situations such as vascular puncture, bone contact, subcutaneous injection encountered, when the caudal block was performed,	Intraoperative first hour
Secondary	age and weight encountered complications	below which age and weight	Intraoperative first hour