Awake Caudal Catheter vs General Anesthesia

Phase 4

Completed

Interventions: Drug: Bupivacaine, Dexmedetomidine, Caffeine, Tylenol
Drug: Propofol, rocuronium, caffeine, Tylenol, bupivacaine

Brief 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).

Detailed Description: This is a prospective, blinded, randomized controlled trial evaluating the effectiveness of awake caudal catheter infusion versus single dose caudal injection and general anesthesia in the surgical management of preterm infant inguinal hernia repair. Spinal anesthesia has been advocated for but highly rejected in the pediatric surgical community due to its high failure rate, which can be up to 28%. Spinal anesthesia is a form of regional anesthesia involving injection of a local anesthetic into the subarachnoid space, via a fine needle, in a single injection. The failure rate has to do with the time constraint of spinal anesthesia, which is approximately 1 hour. It is difficult to perform a bilateral inguinal hernia in that time duration, necessitating a return trip to the operating room for the contralateral side or intubation midway through the surgical case. An alternative to spinal anesthesia that results in an ability to sustain regional anesthetic effect for a longer duration is the caudal catheter infusion. We hypothesize that awake caudal catheter infusion will allow for the following benefits (1) greater than 2 hour anesthetic time via re-dosing which will allow for the completion of the planned surgical procedure (2) exhibit a negligible failure rate (3) minimize post-operative complications that have been associated with general anesthesia in the preterm neonate.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Caudal Infusion	Bupivacaine, Dexmedetomidine, Caffeine, Tylenol	Awake continuous caudal infusion.
General anesthesia	Propofol, rocuronium, caffeine, Tylenol, bupivacaine	General anesthesia and single-dose caudal injection

Primary Outcome Measures

Name	Time	Method
Number of Bradycardia Events.	24 hours post operative	heart rate \<90.
Surgical Completion.	Within 24 hours
Number of Participants With Return to Baseline Respiratory Function.	Within 24 hours post operative
Number of Apneic Episodes.	24 hours post operative	Cessation of breathing by a premature infant that lasts for more than 20 seconds and/or is accompanied by hypoxia or bradycardia.

Secondary Outcome Measures

Name	Time	Method
Days to Hospital Discharge From Surgery	up to 10 days
Number of Participants Returning to Full Feeds.	Within 24 hours post operative
Participants Requiring Mechanical Ventilation.	After 24 hours post operative
Number of Episodes Requiring Post-operative Narcotics Usage.	24 hours post operative
Operative Time.	Intraoperative, up to 100 minutes.

Locations (1): Nemours Children's Clinic
🇺🇸
Jacksonville, Florida, United States