Awake Caudal Catheter vs General Anesthesia

Inguinal Hernia Clinical Trial

Official title:

Awake Caudal Catheter Infusion Versus General Anesthesia and Single-dose Caudal Injection for Preterm Neonatal Intensive Care Unit (NICU) Patients Undergoing Inguinal Herniorrhaphy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05919732
• Other study ID #: 16-03
• Status: Completed
• Phase: Phase 4
• Start date: March 8, 2016
• Est. completion date: March 8, 2018

Study information

• Verified date: March 2024
• Source: Nemours Children's Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 8, 2018
• Est. primary completion date: March 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Weeks to 60 Weeks

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.

Related Conditions & MeSH terms

• Hernia, Inguinal
• Inguinal Hernia

Intervention

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
• 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)

Locations

Country	Name	City	State
United States	Nemours Children's Clinic	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Nemours Children's Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Return to Baseline Respiratory Function.		Within 24 hours post operative
Primary	Surgical Completion.		Within 24 hours
Primary	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
Primary	Number of Bradycardia Events.	heart rate <90.	24 hours post operative
Secondary	Days to Hospital Discharge From Surgery		up to 10 days
Secondary	Number of Episodes Requiring Post-operative Narcotics Usage.		24 hours post operative
Secondary	Operative Time.		Intraoperative, up to 100 minutes.
Secondary	Participants Requiring Mechanical Ventilation.		After 24 hours post operative
Secondary	Number of Participants Returning to Full Feeds.		Within 24 hours post operative