Biplane vs Single Plane Ultrasound for Pediatric Epidural Anesthesia

Recruiting in Palo Alto (17 mi)

Overseen by Sonia Mehta, MD

Age: < 18

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Florida

Must not be taking: Preoperative analgesics

Disqualifiers: Anatomical anomalies, Coagulopathy, Allergy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Ultrasound guidance plays a pivotal role in caudal epidural block in pediatric patients. In comparison to conventional single-plane ultrasound, biplane ultrasound offers the advantage of providing simultaneous transverse and longitudinal imaging. Better visualization under biplane ultrasound is postulated to enhance the efficacy of caudal epidural blocks. This improvement is expected to manifest through higher first puncture success rate, shorter procedure time, and longer time to first postoperative analgesics use.

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 data supports the effectiveness of the treatment Biplane Ultrasound for Pediatric Epidural Anesthesia?

Ultrasound guidance in pediatric regional anesthesia has been shown to improve block characteristics, such as shorter performance time, higher success rates, and better visibility of structures, compared to traditional methods. However, more studies are needed to fully establish its safety advantages over conventional techniques. ^{1 2 3 4 5}

Is ultrasound guidance for pediatric epidural anesthesia safe?

Ultrasound guidance for pediatric regional anesthesia, including epidural anesthesia, is generally considered safe and can help reduce complications like incorrect needle placement and nerve injury. However, more studies are needed to fully confirm its safety advantages over traditional methods. ^{1 6 7 8 9}

How does the Biplane Ultrasound treatment differ from other treatments for pediatric epidural anesthesia?

Biplane Ultrasound offers a unique advantage by providing two-dimensional imaging, which can improve the accuracy and safety of nerve block procedures in children by allowing better visualization of smaller anatomical structures. This method enhances the efficacy of the procedure and reduces the volume of anesthetic needed compared to traditional techniques. ^{1 10 11 12 13}

Research Team

Sonia Mehta, MD

Principal Investigator

University of Florida

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Biplane Ultrasound (Procedure)
• Single plane ultrasound (Procedure)

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.

Participant Groups

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 Canada for the following indications:

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+

Dr. Stephen J. Motew

University of Florida

Chief Executive Officer since 2024

MD cum laude from the University of Illinois at Chicago School of Medicine, Master's in Healthcare Administration from the University of North Carolina at Chapel Hill

Dr. Timothy E. Morey

University of Florida

Chief Medical Officer since 2023

MD and Bachelor's from the University of Florida

Findings from Research

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]

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]

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]

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]

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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Pediatric regional anesthesia. [2009]

2. Korea (South) 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. [2022]

3. United States 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. [2016]

4. France pubmed.ncbi.nlm.nih.gov

Pilot study of neuraxial imaging by ultrasound in infants and children. [2016]

5. Japan 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]. [2016]

6. Italy pubmed.ncbi.nlm.nih.gov

Ultrasound guidance for locoregional anesthesia: a review. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Benefits of Ultrasound Imaging for Placement of Caudal Epidural Blockade in 3 Pediatric Patients: A Case Report. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Lumbar Neuraxial Ultrasound for Spinal and Epidural Anesthesia: A Systematic Review and Meta-Analysis. [2022]

9. England pubmed.ncbi.nlm.nih.gov

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

10. Spain pubmed.ncbi.nlm.nih.gov

[Ultrasound guidance in pediatric regional anesthesia]. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Sonoanatomy of the thoracic spine in adult volunteers. [2022]

12. France pubmed.ncbi.nlm.nih.gov

Ultrasonographic guidance in pediatric regional anesthesia Part 1: Theoretical background. [2016]

13. England pubmed.ncbi.nlm.nih.gov

Identifying barriers to the use of ultrasound in the perioperative period: a survey of southwestern Ontario anesthesiologists. [2020]