Ultrasound-Guided Versus Conventional Injection for Caudal Block

NCT03337191 | Completed

• 1 other identifier: Caudal Ataturk Uni
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Ultrasound Therapy; Complications

Keywords

ultrasound guided caudal injection; sacral hiatus; sacral canal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• block performing time

  Intraoperative first hour

• first puncture success rate

  Intraoperative first hour

Study Arms (2)

ultrasound guided caudal block

ACTIVE COMPARATOR

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

Drug: Levobupivacaine; Drug: Morphine Sulfate; Device: Ultrasound

conventional caudal block

ACTIVE COMPARATOR

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

Drug: Levobupivacaine; Drug: Morphine Sulfate

Interventions

Levobupivacaine DRUG

% 0,125 levobupivacaine

Also known as: ultrasound guided caudal block

conventional caudal block; ultrasound guided caudal block

Morphine Sulfate DRUG

10 mq/kg morphine sulfate

conventional caudal block; ultrasound guided caudal block

Ultrasound DEVICE

Ultrasound guided caudal block

ultrasound guided caudal block

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Erzurum, Turkey (Türkiye)

Location

Related 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. doi: 10.1177/0310057X1404200211.

  PMID: 24580390 BACKGROUND

• 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.

  PMID: 23278906 BACKGROUND

MeSH Terms

Interventions

Levobupivacaine; Morphine; Ultrasonography

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: November 8, 2017
• Study Start: January 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 9, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)