Skip to main content
OpenTrials
Completed

NCT Number: NCT03337191

Ultrasound-Guided Versus Conventional Injection for Caudal Block

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

5 year–12 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Ataturk University

Erzurum, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levobupivacaine

Drug

% 0,125 levobupivacaine

Other names: ultrasound guided caudal block

Morphine sulfate

Drug

10 mq/kg morphine sulfate

Ultrasound

Device

Ultrasound guided caudal block

Primary outcomes

  1. 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

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

Ultrasound-Guided Versus Conventional Injection for Caudal Block in Children

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Nov 8, 2017
Registry last updated
Nov 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.