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NCT05919732 · ClinicalTrials.gov registry record · Phase 4

Awake Caudal Catheter vs General Anesthesia

A Phase 4 study, sponsored by Nemours Children's Clinic.

Completed
Registry status
Phase 4
Development phase
20
Enrollment target

NCT05919732 is a Phase 4 study that has completed, run by Nemours Children's Clinic. The registered enrollment target is 20 participants.

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The verdict

NCT05919732, a Phase 4 study, has completed, sponsored by Nemours Children's Clinic.

COMPLETED
Registry status
Phase 4
Development phase
20 participants
Enrollment target

Study Summary

It is well established that preterm inguinal hernias discovered in the NICU pose a significant surgical risk due to the associated co-morbid conditions that accompany these patients. Currently, the standard of care in the United States is general anesthesia. There have been studies that have established that elective outpatient repair of inguinal hernias found in the NICU can be safely performed. Patients that are ready for discharge from the NICU will have inguinal hernia repair prior to leaving. Inguinal hernia repair will also be done on those premature infants that are seen in the Nemours surgical clinic. Spinal anesthesia is currently the most common anesthetic procedure used in the surgical treatment of preterm inguinal hernias after general anesthesia. Caudal catheter technique has been proven to safely provide post-operative care of premature infants. The caudal catheter technique involves placement of a small catheter under ultrasound guidance into the caudal epidural canal to allow re-dosing of local anesthetic during the case and has been shown to be safe and effective management in neonates (Somri M, 2007).

Interventions

  • DRUG Bupivacaine, Dexmedetomidine, Caffeine, Tylenol
  • DRUG Propofol, rocuronium, caffeine, Tylenol, bupivacaine

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2016-03-08
Est. Completion 2018-03-08
Phase Phase 4

Sponsor

Nemours Children's Clinic

108 total trials

What the Registry Record Tells You About NCT05919732

The ClinicalTrials.gov registry entry for NCT05919732 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nemours Children's Clinic, which has 108 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Bupivacaine, Dexmedetomidine, Caffeine, Tylenol is the first listed.

NCT05919732 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT05919732 about?

NCT05919732 is a clinical study titled "Awake Caudal Catheter vs General Anesthesia". It is well established that preterm inguinal hernias discovered in the NICU pose a significant surgical risk due to the associated co-morbid conditions that accompany these patients. Currently, the standard of care in the United States is general anesthesia. There have been studies that have establi...

What is the current status of trial NCT05919732?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2016-03-08. Estimated completion is 2018-03-08.

What interventions are being tested in trial NCT05919732?

The interventions under investigation include: Bupivacaine, Dexmedetomidine, Caffeine, Tylenol (DRUG), Propofol, rocuronium, caffeine, Tylenol, bupivacaine (DRUG).

Who is sponsoring clinical trial NCT05919732?

This trial is sponsored by Nemours Children's Clinic, which has 108 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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