Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06319989
Other study ID # IRB202301905
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 25, 2024
Est. completion date September 30, 2026

Study information

Verified date March 2024
Source University of Florida
Contact Sonia Mehta, MD
Phone 352-273-7094
Email sdeshmukh@anest.ufl.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Our study aims to recruit pediatric patients receiving caudal epidural blocks as a complement to general anesthesia and for postoperative analgesia. Through a randomized allocation, we will administer the caudal injection with either a biplane ultrasound-guided approach or the single-plane ultrasound-guided technique. The assessment will encompass accuracy metrics, such as the first puncture success rate and number of needle redirections, and the efficiency indicators, including the time from initial probe placement on the skin to successful injection, the time to first postoperative analgesics use, and PACU pain score. Safety evaluation will be conducted, encompassing adverse events from the commencement of the caudal block procedure until discharge. We will also conduct post-discharge follow-up phone calls to evaluate patients' experience after discharge.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 281
Est. completion date September 30, 2026
Est. primary completion date March 25, 2026
Accepts healthy volunteers No
Gender Male
Age group 4 Months to 10 Years
Eligibility Inclusion Criteria: - ASA I/II - Male patients aged 4 months to 10 years - To undergo elective circumcision with caudal epidural anesthesia as an adjuvant to general anesthesia and for postoperative analgesia Exclusion Criteria: - Anatomical anomalies (e.g., tethered cord, sacral malformations, etc.). - Potential coagulopathy. - Preoperative analgesics use. - Allergy to local anesthetics. - Rash or infection at the injection site. - Female patients - Parents refuse to participate.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Biplane Ultrasound
During a standard of care caudal epidural block, biplane ultrasound will be used.
Single plane ultrasound
During a standard of care caudal epidural block, single plane ultrasound will be used.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Florida

Outcome

Type Measure Description Time frame Safety issue
Primary First puncture success The epidural is obtained on first attempt. 1 day
Secondary Number of Needle redirections Redirection was defined as pulling the needle back and changing the direction without exiting the skin. 1day
Secondary Duration of epidural Duration from placing the US probe on skin to successful injection (continuous outcome, measured in second). 1 day
Secondary Postoperative analgesic use The time from arriving at PACU to first postoperative analgesics use within 24 hours after discharge (continuous outcome, measured in hour). 24 hours post-op
See also
  Status Clinical Trial Phase
Recruiting NCT06061003 - 3D Resin Printed Fracture Models for Anatomy Education N/A
Recruiting NCT05483335 - Assessing Burnout in Medical Students in Clerkship Years in United Arab Emirates
Completed NCT04027933 - Standard Patient Simulation in Nursing Students' Approach Toward Patients With Bipolar Disorder N/A
Completed NCT04578821 - Social Justice Advocacy Skills and Ethical Sensitivity N/A
Not yet recruiting NCT03235895 - Evaluation of Internet-Based CME for Wet-cupping Providers N/A
Recruiting NCT04627376 - Multimodal Program for Cancer Related Cachexia Prevention N/A
Active, not recruiting NCT05026619 - Youth Outlook on Life Opportunities Study N/A
Completed NCT04007679 - Pain Neuroscience Education In Students N/A
Completed NCT03154372 - Deliberate Practice With Validated Metrics Improves Skills Acquisition N/A
Completed NCT05208151 - Creative Drama in Physiotherapy and Rehabilitation Education N/A
Completed NCT04042246 - Effect of Knowledge on Vaccine Take-up in Adamawa State, Northeastern Nigeria N/A
Completed NCT06104813 - Evaluation of Deaf Men's Knowledge About Sexual Health
Not yet recruiting NCT03992235 - Importance of Exercise Educational Materials in Chest Physiotherapy N/A
Completed NCT06220708 - Effects Of Dance Movement Therapy On Compassionate Flow In Nursing Students N/A
Completed NCT05010213 - Plaster Patient Education With Roy Adaptation Model N/A
Completed NCT05467969 - Teleteaching on Clinical Procedural Skills
Withdrawn NCT03360357 - Laparoscopic Vaginal Cuff Suturing Profienciency for OBGYN Residents N/A
Completed NCT04507048 - Passive Versus Active Educational Interventions for Melanoma Recognition N/A
Active, not recruiting NCT03847831 - Feasibility Study of the Pilot Post-primary Active School Flag (PPASF) Program N/A
Not yet recruiting NCT03577340 - Development and Validation of Performance Metrics for Cardiac Device Implant Procedures