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Ultrasound-Guided Versus Conventional Injection for Caudal Block

Not Applicable
Completed
Conditions
Ultrasound Therapy; Complications
Interventions
Registration Number
NCT03337191
Lead Sponsor
Ataturk University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
134
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ultrasound guided caudal blockLevobupivacaineCaudal block was performed by ultrasound guided with %0,125 levobupivacaine + 10 mq/kg morphine
ultrasound guided caudal blockUltrasoundCaudal block was performed by ultrasound guided with %0,125 levobupivacaine + 10 mq/kg morphine
conventional caudal blockMorphine SulfateCaudal block was performed by conventional method with %0,125 levobupivacaine + 10 mq/kg morphine
ultrasound guided caudal blockMorphine SulfateCaudal block was performed by ultrasound guided with %0,125 levobupivacaine + 10 mq/kg morphine
conventional caudal blockLevobupivacaineCaudal block was performed by conventional method with %0,125 levobupivacaine + 10 mq/kg morphine
Primary Outcome Measures
NameTimeMethod
success rate of blockIntraoperative 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 Outcome Measures
NameTimeMethod
first puncture success rateIntraoperative 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.

block performing timeIntraoperative first hour

The block time was defined as the period between the insertion of the needle and termination of local anesthetic administration

Trial Locations

Locations (1)

Ataturk University

🇹🇷

Erzurum, Turkey

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