Awake Caudal Catheter vs General Anesthesia

Completed · Phase 4

Conditions studied: Inguinal Hernia

In brief

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).

Key facts

Study ID

NCT05919732

Run by

Nemours Children's Clinic

People needed

20

Starts

2016-03-08

Expected to finish

2018-03-08

Last updated by the study team

2024-04-02

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Preterm infants less than 60 weeks post gestational age born at less than 37 weeks gestational age.
• Patients in the NICU will meet discharge criteria with or without supplemental oxygen prior to surgical scheduling for inguinal hernia repair.

You may not qualify if…

• Patient undergoing other invasive procedures (i.e. gastrostomy tube placement, tracheostomy, laser eye treatment)
• Medical condition that would prevent a regional anesthetic from being performed (i.e. bleeding diathesis, vertebral anomalies, and spinal cord injury prior to surgery)
• Contradictions to the prescribed medications in the protocol.

Where it is running

• Nemours Children's Clinic — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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