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Awake Caudal Catheter vs General Anesthesia

NCT05919732 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-04-02

Study results available
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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).

Conditions

  • Inguinal Hernia

Interventions

DRUG

Bupivacaine, Dexmedetomidine, Caffeine, Tylenol

bupivacaine .3% + 1: 200,000 epinephrine (dose 3mg/kg). Dexmedetomidine 0.5mcg/kg, Caffeine 15mg/kg, rectal Tylenol 30mg/kg

DRUG

Propofol, rocuronium, caffeine, Tylenol, bupivacaine

propofol 3mg/kg and rocuronium 0.6mg/kg. Caffeine 15mg/kg and rectal Tylenol 30mg/kg. single shot caudal with bupivacaine 0.25% + 1:200,000 epinephrine (total dose 2.5mg/kg)

Sponsors & Collaborators

  • Nemours Children's Clinic

    lead OTHER

Principal Investigators

  • Robert B Bryskin, MD · Nemours Children's Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
23 Weeks
Max Age
60 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-08
Primary Completion
2018-03-08
Completion
2018-03-08

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05919732 on ClinicalTrials.gov