Inguinal Hernia
Conditions
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.
Interventions
DRUGPropofol, 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)
DRUGBupivacaine, Dexmedetomidine, Caffeine, Tylenol
bupivacaine .3% + 1: 200,000 epinephrine (dose 3mg/kg). Dexmedetomidine 0.5mcg/kg, Caffeine 15mg/kg, rectal Tylenol 30mg/kg
Sponsors
Nemours Children's Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
The statistician for the study will generate a randomization table. An unblinded research coordinator will prepare randomization envelopes which will be numbered sequentially and placed in a bin located in the secure medication room in the peri-operative suite.Intra-operatively, neither the anesthesiologist nor the surgeon will be blinded since they are present from the induction of anesthesia until the conclusion of the operation for patient safety. The doctors, nurses and others caring for the infant postoperatively will be blinded.
Intervention model description
A prospective, blinded, randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
23 Weeks to 60 Weeks
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Return to Baseline Respiratory Function. | Within 24 hours post operative | — |
| Surgical Completion. | Within 24 hours | — |
| 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. |
| Number of Bradycardia Events. | 24 hours post operative | heart rate \<90. |
Secondary
| Measure | Time frame |
|---|---|
| Days to Hospital Discharge From Surgery | up to 10 days |
| Number of Participants Returning to Full Feeds. | Within 24 hours post operative |
| Number of Episodes Requiring Post-operative Narcotics Usage. | 24 hours post operative |
| Operative Time. | Intraoperative, up to 100 minutes. |
| Participants Requiring Mechanical Ventilation. | After 24 hours post operative |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Caudal Infusion Awake continuous caudal infusion.
Bupivacaine, Dexmedetomidine, Caffeine, Tylenol: bupivacaine .3% + 1: 200,000 epinephrine (dose 3mg/kg). Dexmedetomidine 0.5mcg/kg, Caffeine 15mg/kg, rectal Tylenol 30mg/kg | 11 |
| General Anesthesia General anesthesia and single-dose caudal injection
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) | 9 |
| Total | 20 |
Baseline characteristics
| Characteristic | Caudal Infusion | Total | General Anesthesia |
|---|---|---|---|
| Age, Customized Gestational age | 28.4 weeks STANDARD_DEVIATION 3.3 | 29.1 weeks STANDARD_DEVIATION 3.9 | 30.0 weeks STANDARD_DEVIATION 4.6 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 11 participants | 20 participants | 9 participants |
| Sex: Female, Male Female | 1 Participants | 4 Participants | 3 Participants |
| Sex: Female, Male Male | 10 Participants | 16 Participants | 6 Participants |
| Weight | 3.6 kg STANDARD_DEVIATION 1 | 3.4 kg STANDARD_DEVIATION 1 | 3.1 kg STANDARD_DEVIATION 0.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 9 |
| other Total, other adverse events | 0 / 11 | 0 / 9 |
| serious Total, serious adverse events | 0 / 11 | 0 / 9 |
Outcome results
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.
Time frame: 24 hours post operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caudal Infusion | Number of Apneic Episodes. | 0.1 Episodes | Standard Deviation 0.3 |
| General Anesthesia | Number of Apneic Episodes. | 0.9 Episodes | Standard Deviation 1.2 |
Primary
Number of Bradycardia Events.
heart rate \<90.
Time frame: 24 hours post operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caudal Infusion | Number of Bradycardia Events. | 0 episodes | Standard Deviation 0 |
| General Anesthesia | Number of Bradycardia Events. | 1.0 episodes | Standard Deviation 2 |
Primary
Number of Participants With Return to Baseline Respiratory Function.
Time frame: Within 24 hours post operative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Caudal Infusion | Number of Participants With Return to Baseline Respiratory Function. | 11 Participants |
| General Anesthesia | Number of Participants With Return to Baseline Respiratory Function. | 9 Participants |
Primary
Surgical Completion.
Time frame: Within 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Caudal Infusion | Surgical Completion. | 11 Participants |
| General Anesthesia | Surgical Completion. | 9 Participants |
Secondary
Days to Hospital Discharge From Surgery
Time frame: up to 10 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caudal Infusion | Days to Hospital Discharge From Surgery | 2 Days | Standard Deviation 2 |
| General Anesthesia | Days to Hospital Discharge From Surgery | 1.6 Days | Standard Deviation 0.7 |
Secondary
Number of Episodes Requiring Post-operative Narcotics Usage.
Time frame: 24 hours post operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caudal Infusion | Number of Episodes Requiring Post-operative Narcotics Usage. | 0.3 episodes | Standard Deviation 0.7 |
| General Anesthesia | Number of Episodes Requiring Post-operative Narcotics Usage. | 0 episodes | Standard Deviation 0 |
Secondary
Number of Participants Returning to Full Feeds.
Time frame: Within 24 hours post operative
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Caudal Infusion | Number of Participants Returning to Full Feeds. | 11 participants |
| General Anesthesia | Number of Participants Returning to Full Feeds. | 8 participants |
Secondary
Operative Time.
Time frame: Intraoperative, up to 100 minutes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caudal Infusion | Operative Time. | 57 Minutes | Standard Deviation 28 |
| General Anesthesia | Operative Time. | 53 Minutes | Standard Deviation 33 |
Secondary
Participants Requiring Mechanical Ventilation.
Time frame: After 24 hours post operative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Caudal Infusion | Participants Requiring Mechanical Ventilation. | 0 Participants |
| General Anesthesia | Participants Requiring Mechanical Ventilation. | 0 Participants |