Ultrasound-Guided Versus Conventional Method for Caudal Block

NCT03427437 | Completed

• 1 other identifier: KA 16/354
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 1

Brief Summary

Caudal epidural block has been widely used, especially in pediatric surgery, to supply 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. In particular ultrasonography under longitudinal image is helpful for visualization of the sacral hiatus, sacrococcygeal ligament, duramater, epidural space and the distribution of the local anesthetic agent Therefore, this significantly increases the block success and visualization of where local anesthetic is injected. 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. However age and weight encountered wtih these complications are registered.

Conditions

Ultrasound Therapy; Complications

Keywords

sacral canal; sacral hiatus; ultrasound

Outcome Measures

Primary Outcomes (1)

• success rate of block

  absence of significant motor movements following surgical induction or aberrations in heart and or respiratory rates

  Intraoperative period

Secondary Outcomes (4)

• block performing time

  Intraoperative first hour

• first puncture success rate

  Intraoperative first hour

• complications

  Intraoperative first hour

• age and weight encountered complications

  Intraoperative first hour

Study Arms (2)

Conventional Group

ACTIVE COMPARATOR

Caudal block was performed by conventional method with %0,25 bupivacaine plus 1/200.000 adrenalin

Drug: Bupivacaine; Drug: Adrenalin

Ultrasound Group

ACTIVE COMPARATOR

Caudal block was performed by ultrasound method with %0,25 bupivacaine plus 1/200.000 adrenalin

Drug: Bupivacaine; Drug: Adrenalin; Device: Ultrasound

Interventions

Bupivacaine DRUG

caudal block was performed by conventional and ultrasound method with %0,25 bupivacaine + 1/200000 adrenalin

Also known as: Bustesin,Vem Drug, Ankara, Turkey

Conventional Group; Ultrasound Group

Adrenalin DRUG

caudal block was performed by conventional and ultrasound method with %0,25 bupivacaine + 1/200000 adrenalin

Also known as: Adrenalin 0.5 mg, Osel Drug, Istanbul, Turkey

Conventional Group; Ultrasound Group

Ultrasound DEVICE

caudal block was performed by ultrasound method

Also known as: Sonosite M Turbo, USA

Ultrasound Group

Eligibility Criteria

• Age: 6 Months - 8 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASA (American Society of Anesthesiologist) I children aged between 6 months and 8 years old who underwent elective hypospadias, circumcision and both surgery

You may not qualify if:

• 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

• Omer Karaca: lead
• Baskent University: collaborator

Study Sites (1)

Baskent University

Konya, Turkey (Türkiye)

Location

Related Publications (2)

• 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 RESULT

• Ahiskalioglu A, Yayik AM, Ahiskalioglu EO, Ekinci M, Golboyu BE, Celik EC, Alici HA, Oral A, Demirdogen SO. Ultrasound-guided versus conventional injection for caudal block in children: A prospective randomized clinical study. J Clin Anesth. 2018 Feb;44:91-96. doi: 10.1016/j.jclinane.2017.11.011. Epub 2017 Nov 21.

  PMID: 29161549 RESULT

MeSH Terms

Interventions

Bupivacaine; Epinephrine; Ultrasonography

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Omer Karaca, MD

  Baskent University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Double Participant, Outcomes Assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: February 9, 2018
• Study Start: February 1, 2017
• Primary Completion: November 1, 2017
• Study Completion: January 1, 2018
• Last Updated: February 9, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)