Awake Caudal Catheter Infusion Versus General Anesthesia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Awake Caudal Catheter Infusion Versus General Anesthesia and Single-dose Caudal Injection for Preterm NICU Patients Undergoing Inguinal Herniorraphy.

Conditions
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Inguinal Hernia

Intervention / Treatment
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* Drug: Bupivacaine and epinephrine infusion


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 23 Weeks
Maximum Age: 60 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective, blinded, randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The Caudal Infusion Group<br>Continuous caudal infusion. | Drug: Bupivacaine and epinephrine infusion<br>* For caudal infusion group: bupivacaine .3% + 1: 200,000 epinephrine (dose 3mg/kg) will be administered via the catheter. For general anesthesia group: bupivacaine 0.25% + 1:200,000 epinephrine (total dose 2.5mg/kg) prior to start of the surgery.<br>|
| Active Comparator: The General Anesthesia Group<br>Single caudal injection with general anesthesia. | Drug: Bupivacaine and epinephrine infusion<br>* For caudal infusion group: bupivacaine .3% + 1: 200,000 epinephrine (dose 3mg/kg) will be administered via the catheter. For general anesthesia group: bupivacaine 0.25% + 1:200,000 epinephrine (total dose 2.5mg/kg) prior to start of the surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time it takes to return to baseline respiratory function. |  | 24 hours post operative | 
| Success of surgical completion. |  | 24 hours post operative | 
| Number of apneic episodes. | Cessation of breathing by a premature infant that lasts for more than 20 seconds and/or is accompanied by hypoxia or bradycardia. | 24 hours post operative | 
| Number of bradycardia events. | heart rate <90. | 24 hours post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease days to hospital discharge. |  | 24 hours post operative | 
| Decreased number of post-operative narcotics used per day. |  | 24 hours post operative | 
| Decreased operative time. |  | 24 hours post operative | 
| Decreased days of mechanical ventilation. |  | 24 hours post operative | 
| Decreased time to full feeds. |  | 24 hours post operative |