Awake Caudal Catheter Infusion Versus General Anesthesia
Condition: Inguinal Hernia
MeSH terms: Hernia, Inguinal
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Bupivacaine and epinephrine infusion
Intervention type(s): Drug
Intervention description(s): 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.
Intervention MeSH terms: Epinephrine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A prospective, blinded, randomized controlled trial
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment