Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caudal Infusion | Experimental | Awake continuous caudal infusion. |
|
| General anesthesia | Active Comparator | General anesthesia and single-dose caudal injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine, Dexmedetomidine, Caffeine, Tylenol | Drug | bupivacaine .3% + 1: 200,000 epinephrine (dose 3mg/kg). Dexmedetomidine 0.5mcg/kg, Caffeine 15mg/kg, rectal Tylenol 30mg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Return to Baseline Respiratory Function. | Within 24 hours post operative | |
| Surgical Completion. | 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. | 24 hours post operative |
| Number of Bradycardia Events. | heart rate <90. | 24 hours post operative |
| Measure | Description | Time Frame |
|---|---|---|
| Days to Hospital Discharge From Surgery | up to 10 days | |
| Number of Episodes Requiring Post-operative Narcotics Usage. | 24 hours post operative | |
| Operative Time. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert B Bryskin, MD | Nemours Children's Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemours Children's Clinic | Jacksonville | Florida | 32207 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | General Anesthesia |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Return to Baseline Respiratory Function. | Posted | Count of Participants | Participants | Within 24 hours post operative |
|
Within 24 hours post-operative
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gohalem Felema | Nemours | 904-416-5430 | gohalem.felema@nemours.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 22, 2015 | Nov 28, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D020927 | Dexmedetomidine |
| D002110 | Caffeine |
| D000082 | Acetaminophen |
| D015742 | Propofol |
| D000077123 | Rocuronium |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
Not provided
Not provided
A prospective, blinded, randomized controlled trial
Not provided
Not provided
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.
| Propofol, rocuronium, caffeine, Tylenol, bupivacaine | Drug | 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) |
|
| Intraoperative, up to 100 minutes. |
| Participants Requiring Mechanical Ventilation. | After 24 hours post operative |
| Number of Participants Returning to Full Feeds. | Within 24 hours post operative |
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) |
| BG002 | Total | Total of all reporting groups |
| weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kg |
|
|
|
| Primary | Surgical Completion. | Posted | Count of Participants | Participants | 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. | Posted | Mean | Standard Deviation | Episodes | 24 hours post operative |
|
|
|
| Primary | Number of Bradycardia Events. | heart rate <90. | Posted | Mean | Standard Deviation | episodes | 24 hours post operative |
|
|
|
| Secondary | Days to Hospital Discharge From Surgery | Posted | Mean | Standard Deviation | Days | up to 10 days |
|
|
|
| Secondary | Number of Episodes Requiring Post-operative Narcotics Usage. | Posted | Mean | Standard Deviation | episodes | 24 hours post operative |
|
|
|
| Secondary | Operative Time. | Posted | Mean | Standard Deviation | Minutes | Intraoperative, up to 100 minutes. |
|
|
|
| Secondary | Participants Requiring Mechanical Ventilation. | Posted | Count of Participants | Participants | After 24 hours post operative |
|
|
|
| Secondary | Number of Participants Returning to Full Feeds. | Posted | Number | participants | Within 24 hours post operative |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | 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) | 0 | 9 | 0 | 9 | 0 | 9 |
Not provided
Not provided
Not provided
| D000588 |
| Amines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000083 | Acetanilides |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |