A Phase 4 interventional study of Bupivacaine, Dexmedetomidine, Caffeine, Tylenol and Propofol, rocuronium, caffeine, Tylenol, bupivacaine in Inguinal Hernia, sponsored by Nemours Children's Clinic. Completed at 1 site in United States. Open to participants aged 23 Weeks to 60 Weeks. Per ClinicalTrials.gov, last updated 2024-04-02.
Sponsored by Nemours Children's Clinic · Phase 4, Interventional, and Treatment
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).
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.
549 studies on the registry are indexed under Hernia, Inguinal; 74 are open to participants now.
This study's enrollment of 20 is below the median of 90 across 406 interventional studies indexed under Hernia, Inguinal.
Browse Hernia, Inguinal studies →Nemours Children's Clinic is the lead sponsor of 127 studies on the registry; 27 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Awake continuous caudal infusion.
Drug: Bupivacaine, Dexmedetomidine, Caffeine, Tylenol
General anesthesia and single-dose caudal injection
Drug: Propofol, rocuronium, caffeine, Tylenol, bupivacaine
bupivacaine .3% + 1: 200,000 epinephrine (dose 3mg/kg). Dexmedetomidine 0.5mcg/kg, Caffeine 15mg/kg, rectal Tylenol 30mg/kg
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)
Number of Participants With Return to Baseline Respiratory Function.
Time frame: Within 24 hours post operative
Surgical Completion.
Time frame: Within 24 hours
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.
Time frame: 24 hours post operative
Number of Bradycardia Events.
heart rate \<90.
Time frame: 24 hours post operative
Days to Hospital Discharge From Surgery
Time frame: up to 10 days
Number of Episodes Requiring Post-operative Narcotics Usage.
Time frame: 24 hours post operative
Operative Time.
Time frame: Intraoperative, up to 100 minutes.
Participants Requiring Mechanical Ventilation.
Time frame: After 24 hours post operative
Number of Participants Returning to Full Feeds.
Time frame: Within 24 hours post operative
| Milestone | Caudal Infusion | General Anesthesia |
|---|---|---|
| Started | 11 | 9 |
| Completed | 11 | 9 |
| Not completed | 0 | 0 |
| Participants | Caudal Infusion | General Anesthesia |
|---|---|---|
| Number of Participants With Return to Baseline Respiratory Function. | 11 | 9 |
| Participants | Caudal Infusion | General Anesthesia |
|---|---|---|
| Surgical Completion. | 11 | 9 |
Cessation of breathing by a premature infant that lasts for more than 20 seconds and/or is accompanied by hypoxia or bradycardia.
| Episodes | Caudal Infusion | General Anesthesia |
|---|---|---|
| Number of Apneic Episodes. | 0.1 ± 0.3 | 0.9 ± 1.2 |
heart rate \<90.
| episodes | Caudal Infusion | General Anesthesia |
|---|---|---|
| Number of Bradycardia Events. | 0 ± 0 | 1.0 ± 2.0 |
| Days | Caudal Infusion | General Anesthesia |
|---|---|---|
| Days to Hospital Discharge From Surgery | 2 ± 2 | 1.6 ± 0.7 |
| episodes | Caudal Infusion | General Anesthesia |
|---|---|---|
| Number of Episodes Requiring Post-operative Narcotics Usage. | 0.3 ± 0.7 | 0 ± 0 |
| Minutes | Caudal Infusion | General Anesthesia |
|---|---|---|
| Operative Time. | 57 ± 28 | 53 ± 33 |
| Participants | Caudal Infusion | General Anesthesia |
|---|---|---|
| Participants Requiring Mechanical Ventilation. | 0 | 0 |
| participants | Caudal Infusion | General Anesthesia |
|---|---|---|
| Number of Participants Returning to Full Feeds. | 11 | 8 |
Collected over Within 24 hours post-operative. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Caudal Infusion | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| General Anesthesia | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Age, Customized(weeks) | Caudal Infusion | General Anesthesia | Total |
|---|---|---|---|
| Gestational age | 28.4 ± 3.3 | 30.0 ± 4.6 | 29.1 ± 3.9 |
| Sex: Female, Male(Participants) | Caudal Infusion | General Anesthesia | Total |
|---|---|---|---|
| Female | 1 | 3 | 4 |
| Male | 10 | 6 | 16 |
| Race and Ethnicity Not Collected(Participants) | Caudal Infusion | General Anesthesia | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Caudal Infusion | General Anesthesia | Total |
|---|---|---|---|
| United States | 11 | 9 | 20 |
| Weight(kg) | Caudal Infusion | General Anesthesia | Total |
|---|---|---|---|
| Mean | 3.6 ± 1.0 | 3.1 ± 0.9 | 3.4 ± 1.0 |
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