Skip to main content
Clinical Trials/NCT03337191
NCT03337191
Completed
Not Applicable

Ultrasound-Guided Versus Conventional Injection for Caudal Block in Children

Ataturk University1 site in 1 country134 target enrollmentJanuary 1, 2016

Overview

Phase
Not Applicable
Intervention
Levobupivacaine
Conditions
Ultrasound Therapy; Complications
Sponsor
Ataturk University
Enrollment
134
Locations
1
Primary Endpoint
success rate of block
Status
Completed
Last Updated
8 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
January 1, 2016
End Date
September 1, 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ali Ahiskalioglu

Principal Investigator

Ataturk University

Eligibility Criteria

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

Arms & Interventions

ultrasound guided caudal block

Caudal block was performed by ultrasound guided with %0,125 levobupivacaine + 10 mq/kg morphine

Intervention: Levobupivacaine

ultrasound guided caudal block

Caudal block was performed by ultrasound guided with %0,125 levobupivacaine + 10 mq/kg morphine

Intervention: Morphine Sulfate

ultrasound guided caudal block

Caudal block was performed by ultrasound guided with %0,125 levobupivacaine + 10 mq/kg morphine

Intervention: Ultrasound

conventional caudal block

Caudal block was performed by conventional method with %0,125 levobupivacaine + 10 mq/kg morphine

Intervention: Levobupivacaine

conventional caudal block

Caudal block was performed by conventional method with %0,125 levobupivacaine + 10 mq/kg morphine

Intervention: Morphine Sulfate

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • first puncture success rate(Intraoperative first hour)
  • block performing time(Intraoperative first hour)

Study Sites (1)

Loading locations...

Similar Trials