Ultrasound-Guided Versus Conventional Injection for Caudal Block

Ultrasound Therapy; Complications Clinical Trial

Official title:

Ultrasound-Guided Versus Conventional Injection for Caudal Block in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03337191
• Other study ID #: Caudal Ataturk Uni
• Status: Completed
• Phase: N/A
• First received: November 6, 2017
• Last updated: November 7, 2017
• Start date: January 1, 2016
• Est. completion date: September 1, 2016

Study information

• Verified date: November 2017
• Source: Ataturk 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: September 1, 2016
• Est. primary completion date: July 1, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 5 Years to 12 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologist's physiologic state I-II patients undergoing phimosis and circumcision surgery

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Ultrasound Therapy; Complications

Intervention

Drug:
• Levobupivacaine
% 0,125 levobupivacaine
• Morphine Sulfate
10 mq/kg morphine sulfate

Device:
• Ultrasound
Ultrasound guided caudal block

Locations

Country	Name	City	State
Turkey	Ataturk University	Erzurum

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — 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 2012 Dec 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Intraoperative first hour
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