Ultrasound-Guided Versus Conventional Method for Caudal Block

NCT ID: NCT03427437

Last Updated: 2018-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 275 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2018-01-01

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.

Detailed Description

The caudal block was performed in Group C by via conventional methods. The sacral cornus and the sacral hiatus were palpated. After sterilization of the region, a 22- gauge caudal needle was inserted into the skin with at a 60-80 degree angle and until the sacrococcygeal ligament was passed punctured, as determined with by a "popping sensation." feeling (puncture of the sacrococcygeal ligament). Then, the angle of the needle was then reduced to 20-30 degrees and inserted further for an additional 2-3mm, entering into the sacral canal. After verifingverifying the absence of any blood or cerebrospinal fluid in the aspiration, a test dose of 0.1 ml/kg of local anesthetic (LA) with adrenalin at a ratio of 1: 200000 was injected under hemodynamic and ECG monitoring. Following a negative test dose, the rest of the LA was slowly injected slowly over 1 min. In the case of the needle touching the bony tissue, blood aspiration, or bulging into of the subcutaneous tissue, the angle of the needle was changed and the intervention was repeated.

The caudal block was performed by via ultrasound guided ultrasound guidance in Group U. After sterilization of the region and using ultrasound guidanceUSG with a sterile plastic cover and gel, the sacral hiatus was visualized via an out-of-plane technique at the level of the sacral cornus at the out of plane via the lineerlinear transducer of an M-Turbo ultrasound machine (TM; Fujifilm SonoSite Inc., (Washington, WA, United StatesUSA) ultrasound machine at 13 MHz, and the, depth and gain was adjusted to for optimal visual quality. The ultrasound ultrasound transducer was first placed transversely at the midlain midline to obtain the transvers view of the two cornua, the sacrococcygeal ligament, the sacral bone, and the sacral hiatus. At this level, the ultrasound ultrasound transducer was rotated 90 degrees to obtain the longitudinal view of the sacrococcygeal ligamantligament and sacral hiatus, and was then placed between the two cornua. A 22- gauge caudal needle was advanced toward the upper third of the sacrococcygeal ligament. The needle advancement was terminated right after penetrating the sacrococcygeal ligament. At this level, after confirming the absence of any blood or cerebrospinal fluid in the aspiration and a negative test dose, the rest of the LA was injected over 1 min under while observing the ultrasound ultrasound longitudinal image

Conditions

Ultrasound Therapy; Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Conventional Group

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

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

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

Adrenalin

Intervention Type: DRUG

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

Ultrasound Group

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

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

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

Adrenalin

Intervention Type: DRUG

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

Ultrasound

Intervention Type: DEVICE

caudal block was performed by ultrasound method

Interventions

Bupivacaine

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

Intervention Type: DRUG

Adrenalin

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

Intervention Type: DRUG

Ultrasound

caudal block was performed by ultrasound method

Intervention Type: DEVICE

Other Intervention Names

Bustesin,Vem Drug, Ankara, Turkey; Adrenalin 0.5 mg, Osel Drug, Istanbul, Turkey; Sonosite M Turbo, USA

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 8 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Baskent University

OTHER

Sponsor Role: collaborator

Omer Karaca

OTHER

Sponsor Role: lead

Responsible Party

Omer Karaca

Medical Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Omer Karaca, MD

Role: PRINCIPAL_INVESTIGATOR

Baskent University

Locations

Baskent University

Konya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 23278906 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29161549 (View on PubMed)

Other Identifiers

KA 16/354

Identifier Type: -

Identifier Source: org_study_id