Phase 4
Completed N=20
Awake Caudal Catheter vs General Anesthesia
Source: ClinicalTrials.gov NCT05919732 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcomePrimary: Number of Participants With Return to Baseline Respiratory Function. — 11; 9 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Return to Baseline Respiratory Function. |
11; 9 | — |
| PRIMARY Surgical Completion. |
11; 9 | — |
| PRIMARY Number of Apneic Episodes. |
0.1; 0.9 | — |
| PRIMARY Number of Bradycardia Events. |
0; 1.0 | — |
| SECONDARY Days to Hospital Discharge From Surgery |
2; 1.6 | — |
| SECONDARY Number of Episodes Requiring Post-operative Narcotics Usage. |
0.3; 0 | — |
| SECONDARY Operative Time. |
57; 53 | — |
| SECONDARY Participants Requiring Mechanical Ventilation. |
0; 0 | — |
| SECONDARY Number of Participants Returning to Full Feeds. |
11; 8 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT05919732). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.