Biplane vs Single Plane Ultrasound for Pediatric Epidural Anesthesia

Overseen By Federico Jimenez, MD

Age: < 18

Sex: Male

Trial Phase: Academic

Sponsor: University of Florida

Must not be taking: Preoperative analgesics

Disqualifiers: Anatomical anomalies, Coagulopathy, Allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if biplane ultrasound, which offers two types of imaging simultaneously, is superior to the usual single-plane ultrasound for guiding epidural anesthesia in children. This method could make the procedure faster and more effective, providing longer pain relief after surgery. The trial seeks boys aged 4 months to 10 years undergoing circumcision surgery who will receive epidural anesthesia for pain management. As an unphased trial, this study presents a unique opportunity to contribute to innovative research that could enhance medical procedures for children.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those who use preoperative pain relievers.

What prior data suggests that biplane and single plane ultrasound guidance is safe for pediatric epidural anesthesia?

Research shows that using ultrasound, especially for children undergoing anesthesia, is generally safe. Studies have found that biplane ultrasound can make nerve block procedures safer by providing clearer images. This clarity helps doctors see better, reducing errors.

Previous studies comparing biplane with single-plane ultrasound focused on effectiveness rather than harmful effects. When guiding procedures, ultrasound technology itself usually does not cause harm. A review of ultrasound use in children's anesthesia reported no serious safety issues.

Overall, procedures guided by ultrasound, like those in this study, are well-tolerated by patients. While the studies did not highlight specific adverse reactions, using ultrasound is considered safe because it helps doctors perform procedures more accurately. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it compares two ultrasound techniques for guiding pediatric epidural anesthesia, potentially improving safety and effectiveness. Unlike the single-plane ultrasound, which is the conventional method, biplane ultrasound provides a two-dimensional view, offering more detailed guidance for needle placement. This could lead to more precise epidural blocks, reducing the risk of complications and improving pain management for young patients. By exploring these methods, the trial aims to optimize anesthesia practices, making procedures safer and more comfortable for children.

What evidence suggests that biplane ultrasound is effective for pediatric epidural anesthesia?

This trial will compare the effectiveness of biplane ultrasound with single-plane ultrasound for guiding caudal epidural blocks in children. Research has shown that biplane ultrasound might enhance these procedures by providing two-dimensional images that improve accuracy and safety. Studies suggest that biplane ultrasound could result in more successful first attempts and shorter procedure times compared to the traditional single-plane method. However, single-plane ultrasound is already known to improve success rates and reduce procedure time. Both methods use ultrasound guidance, which generally enhances the quality of epidural anesthesia. ^{2 3 6 7 8}

Who Is on the Research Team?

Sonia Mehta, MD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for male pediatric patients aged 4 months to 10 years who are scheduled for elective circumcision and require caudal epidural anesthesia. They should be generally healthy (ASA I/II) and the anesthesia is used alongside general anesthesia for pain relief after surgery.

Inclusion Criteria

I am in good or mild systemic disease state.

I am a boy between 4 months and 10 years old.

I am planning to have a circumcision with additional anesthesia for pain relief.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive caudal epidural block under either biplane or single-plane ultrasound guidance

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure, including post-discharge follow-up phone calls

24 hours

1 follow-up call

What Are the Treatments Tested in This Trial?

Interventions

• Biplane Ultrasound
• Single plane ultrasound

Trial Overview The study compares two types of ultrasound guidance: single plane and biplane, in facilitating caudal epidural blocks during pediatric surgeries. The goal is to see if biplane ultrasound, which shows two views at once, leads to quicker procedures with fewer attempts needed and longer-lasting pain relief post-surgery.

How Is the Trial Designed?

Group I: Single plane Ultrasound Experimental Treatment 1 Intervention

The procedures for patients in the control group will be guided by conventional single-plane ultrasound.

Group II: Biplane Ultrasound Experimental Treatment 1 Intervention

The intervention group will receive caudal epidural block under the guidance of biplane ultrasound.

Biplane Ultrasound is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Biplane Ultrasound Guidance for:

• Pediatric caudal epidural anesthesia

Approved in United States as Biplane Ultrasound Guidance for:

• Pediatric caudal epidural anesthesia

Approved in Canada as Biplane Ultrasound Guidance for:

• Pediatric caudal epidural anesthesia

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Published Research Related to This Trial

Pediatric regional anesthesia is now widely recognized for its efficacy and safety, supported by extensive international literature, and has improved significantly with the development of safer drugs and dedicated pediatric tools.

Ultrasound guidance in pediatric regional anesthesia enhances block characteristics, leading to higher success rates and reduced anesthetic volume, although its safety advantages over traditional techniques have not been fully established due to limited randomized control trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric regional anesthesia. Ivani, G., Mosseti, V.[2009]

Ultrasound imaging of the thoracic spine in the right paramedian sagittal oblique (PSO) plane is significantly more effective than the transverse median (TM) plane, with a conclusive image rate of 74.5% compared to 37.5%.

In the lower thoracic levels, the conclusive image rate is very high (98%), but this decreases in the upper thoracic levels, indicating that the PSO plane is preferable for thoracic epidural anesthesia due to better visibility of critical anatomical structures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sonoanatomy of the thoracic spine in adult volunteers. Avramescu, S., Arzola, C., Tharmaratnam, U., et al.[2022]

A study involving 32 infants and children found that using a linear ultrasound probe provided superior imaging of neuraxial structures compared to a sector probe, which is crucial for successful epidural anesthesia.

The paramedian longitudinal scanning technique yielded the best visibility of the spinal cord, especially in neonates up to 3 months old, suggesting this method could enhance the safety and efficacy of ultrasound-guided epidural anesthesia in young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study of neuraxial imaging by ultrasound in infants and children. Marhofer, P., Bösenberg, A., Sitzwohl, C., et al.[2016]

Ultrasound imaging significantly improves the efficacy and safety of pediatric nerve block procedures, especially for spinal blocks and nerve trunk blocks like the umbilical and ilioinguinal nerves.

Using a high-frequency linear array transducer (7-10 MHz) is recommended for better visualization of smaller anatomical structures in children, although the main challenges include the cost of equipment and the learning curve for practitioners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Ultrasound guidance in pediatric regional anesthesia]. de Josemaría, B., Gálvez, I., Reinoso-Barbero, F.[2019]

Ultrasonographic guidance is increasingly supported for use in pediatric regional anesthesia, enhancing the safety and precision of the procedure.

The article emphasizes the importance of understanding ultrasound physics and the appearance of neuronal structures to ensure effective and safe application in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasonographic guidance in pediatric regional anesthesia Part 1: Theoretical background. Marhofer, P., Frickey, N.[2016]

In a survey of 66 anesthesiologists in southwestern Ontario, over 80% reported using ultrasound (US) guidance primarily for central venous catheter insertion and regional blocks, indicating its effectiveness in these procedures.

Despite a strong interest in using US more frequently, 59% of respondents cited limited access to ultrasound machines as a major barrier, suggesting that improving resource availability is crucial for enhancing US utilization in anesthesia practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying barriers to the use of ultrasound in the perioperative period: a survey of southwestern Ontario anesthesiologists. Chui, J., Lavi, R., Hegazy, AF., et al.[2020]

Ultrasound-guided epidural placement in pediatric patients resulted in a higher first attempt success rate (87.0%) compared to landmark-guided placement (40.9%), indicating improved efficacy in achieving successful catheter placement.

The use of ultrasound also significantly reduced the number of needle redirections and bone contacts, leading to fewer complications, although the time taken to access the epidural space was similar between both techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of landmark and real-time ultrasound-guided epidural catheter placement in the pediatric population: a prospective randomized comparative trial. Mital, T., Kamal, M., Kumar, M., et al.[2022]

Ultrasound imaging in pediatric neuraxial anesthesia can enhance the accuracy of needle and catheter placement, particularly allowing for direct visualization in young infants, which may improve safety and efficacy.

Current literature suggests that while ultrasound can predict the depth to loss of resistance and visualize the procedure, more rigorous studies are needed to confirm its advantages over traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound imaging for regional anesthesia in infants, children, and adolescents: a review of current literature and its application in the practice of neuraxial blocks. Tsui, BC., Suresh, S.[2016]

Ultrasound guidance in regional anaesthesia significantly enhances the safety and efficacy of procedures by allowing for precise catheter placement and visualization of local anesthetic spread, which helps reduce the required doses.

The use of ultrasound can minimize common complications associated with regional blocks, such as intravascular injection and nerve injury, while also facilitating faster onset of anaesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound guidance for locoregional anesthesia: a review. Baldi, C., Bettinelli, S., Grossi, P., et al.[2016]

Ultrasound guidance significantly improved the safety and success of pediatric caudal epidural blockade by allowing real-time visualization, which helped prevent complications such as incorrect needle placement and subarachnoid injection.

In three cases involving infants and young children, ultrasound facilitated proper needle placement and confirmed issues like needle blockage, suggesting that its routine use could enhance the effectiveness of this common anesthetic technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of Ultrasound Imaging for Placement of Caudal Epidural Blockade in 3 Pediatric Patients: A Case Report. Sinskey, JL., Vecchione, TM., Ekstrom, BG., et al.[2021]

In a study of 34 cesarean delivery patients, both longitudinal and transverse ultrasound approaches accurately measured the distance from the skin to the dura, correlating well with actual needle depth.

The longitudinal ultrasound view provided significantly better imaging quality compared to the transverse view, suggesting it may be the preferred method for facilitating lumbar epidural anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy of ultrasound imaging of lumbar epidural anesthesia in patients for cesarean delivery: A comparative study between longitudinal and transverse plane imaging]. Kakumoto, M., Mimura, F., Yamaguchi, M., et al.[2016]

Neuraxial ultrasound significantly improves the accuracy of identifying lumbar intervertebral spaces and predicting the needle insertion depth for spinal and epidural anesthesia, with a mean difference of less than 3 mm in most studies.

The use of ultrasound in these procedures increases the success rate and ease of performance, while also potentially reducing the risk of traumatic procedures, although more evidence is needed to definitively conclude its impact on overall safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lumbar Neuraxial Ultrasound for Spinal and Epidural Anesthesia: A Systematic Review and Meta-Analysis. Perlas, A., Chaparro, LE., Chin, KJ.[2022]

The review analyzed 211 publications on ultrasound imaging in pediatric regional anesthesia, ultimately including 24 studies that provided some evidence supporting the use of ultrasound for improving outcomes in nerve blocks and neuraxial anesthesia.

Despite the promising findings, the review emphasizes the need for more randomized controlled trials with larger sample sizes to better assess the efficacy and safety of ultrasound in reducing complications during regional anesthesia in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based medicine: Assessment of ultrasound imaging for regional anesthesia in infants, children, and adolescents. Tsui, BC., Pillay, JJ.[2019]

Citations

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The Efficacy of Biplane Versus Single Plane Ultrasound in ... Better visualization under biplane ultrasound is postulated to enhance the efficacy of caudal epidural blocks. This improvement is expected to ...

2. withpower.com withpower.com/trial/phase-educational-problems-2-2024-67ffb

Biplane vs Single Plane Ultrasound for Pediatric Epidural ... Biplane Ultrasound offers a unique advantage by providing two-dimensional imaging, which can improve the accuracy and safety of nerve block procedures in ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12174558/

Erector spinae plane block versus caudal epidural ... This meta-analysis systematically approaches this question through the comparison of the analgesic efficacy and safety of CEB versus ESPB in ...

4. rapm.bmj.com rapm.bmj.com/content/50/Suppl_1/A24.2

OP38 Evaluation of accuracy of pediatric caudal epidural ... Results A total of 70 pediatric patients were included. The first-pass success rate of landmark-guided caudal epidural needle placement was 62.8%, with an ...

5. pocusjournal.com pocusjournal.com/article/16298/

A Prospective Cohort Study to Evaluate Needle Passes ... This prospective study compared the number of needle passes, redirections, and procedural time between epidural placed with a handheld ultrasound versus ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8083139/

Ultrasound in paediatric anaesthesia – A comprehensive review In this review, we discuss the use of ultrasound in various aspects of paediatric anaesthesia and how it can be used to assist diagnostic and therapeutic ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0104001422000343

Real-time ultrasound-guided epidural catheter placement ... We present a case series in which real-time US-guided epidural catheter placement was performed in 10 infants in lower thoracic and upper lumbar interspaces.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8828618/

Comparison of landmark and real-time ultrasound-guided ... The primary outcome was a comparison of the procedure time (excluding US probe preparation). Secondary outcomes were the number of attempts (re-insertion of the ...