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Ultrasound-Guided Versus Conventional Injection for Caudal Block

Ultrasound-Guided Versus Conventional Injection for Caudal Block in Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03337191
Enrollment
134
Registered
2017-11-08
Start date
2016-01-01
Completion date
2016-09-01
Last updated
2017-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ultrasound Therapy; Complications

Keywords

ultrasound guided caudal injection, sacral hiatus, sacral canal

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.

Interventions

DRUGLevobupivacaine

% 0,125 levobupivacaine

DRUGMorphine Sulfate

10 mq/kg morphine sulfate

DEVICEUltrasound

Ultrasound guided caudal block

Sponsors

Ataturk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
5 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
success rate of blockIntraoperative first hourA 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

MeasureTime frameDescription
block performing timeIntraoperative first hourThe block time was defined as the period between the insertion of the needle and termination of local anesthetic administration
first puncture success rateIntraoperative first hourThe 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026