Inguinal HerniaPhase 4NCT05919732
Awake Caudal Catheter vs General Anesthesia
A Phase 4 study testing Bupivacaine, Dexmedetomidine, Caffeine, Tylenol and Propofol, rocuronium, caffeine, Tylenol, bupivacaine in people with Inguinal Hernia, run by Nemours Children's Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 23 to 60 weeks
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Bupivacaine, Dexmedetomidine, Caffeine, Tylenol and Propofol, rocuronium, caffeine, Tylenol, bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2016to 8 Mar 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 60 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nemours Children's Clinic
Jacksonville, Florida, 32207
About this study
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.
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).
Read the 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.
- Conditions
- Inguinal Hernia
- Being tested
- Bupivacaine, Dexmedetomidine, Caffeine, Tylenol, Propofol, rocuronium, caffeine, Tylenol, bupivacaine
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine, Dexmedetomidine, Caffeine, TylenolDrug
bupivacaine .3% + 1: 200,000 epinephrine (dose 3mg/kg). Dexmedetomidine 0.5mcg/kg, Caffeine 15mg/kg, rectal Tylenol 30mg/kg
Propofol, rocuronium, caffeine, Tylenol, bupivacaineDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Caudal Infusion | Experimental | Awake continuous caudal infusion. Receives: Drug: Bupivacaine, Dexmedetomidine, Caffeine, Tylenol |
| General anesthesia | Active comparator | General anesthesia and single-dose caudal injection Receives: Drug: Propofol, rocuronium, caffeine, Tylenol, bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Return to Baseline Respiratory Function.
Measured: Within 24 hours post operative
Surgical Completion.
Measured: 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.
Measured: 24 hours post operative
Number of Bradycardia Events.
heart rate <90.
Measured: 24 hours post operative
Secondary outcomes (5)
Days to Hospital Discharge From Surgery
Measured: up to 10 days
Number of Episodes Requiring Post-operative Narcotics Usage.
Measured: 24 hours post operative
Operative Time.
Measured: Intraoperative, up to 100 minutes.
Participants Requiring Mechanical Ventilation.
Measured: After 24 hours post operative
Number of Participants Returning to Full Feeds.
Measured: Within 24 hours post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start8 Mar 2016
- Primary completion8 Mar 2018
- Study completion8 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, blinded, randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gohalem Felema, Nemours Children's Clinic
- Investigators
- Robert B Bryskin, MD, Principal investigator, Nemours Children's Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919732
- Sponsor's protocol ID
- 16-03
- Status last verified
- Mar 2024
- First submitted
- 16 Jun 2023
- Last updated
- 2 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05919732
- Acronym / sponsor ID
- 16-03
- Conditions
- Inguinal Hernia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Study start
- 8 Mar 2016 (actual)
- Primary completion
- 8 Mar 2018 (actual)
- Study completion
- 8 Mar 2018 (actual)
- First posted
- 26 Jun 2023 (actual)
- Results
- Posted 2 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- A prospective, blinded, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Caudal Infusion | Experimental | Drug: Bupivacaine, Dexmedetomidine, Caffeine, TylenolAwake continuous caudal infusion. |
| General anesthesia | Active comparator | Drug: Propofol, rocuronium, caffeine, Tylenol, bupivacaineGeneral anesthesia and single-dose caudal injection |
Who may qualify
- Ages
- 23 to 60 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine, Dexmedetomidine, Caffeine, Tylenolbupivacaine .3% + 1: 200,000 epinephrine (dose 3mg/kg). Dexmedetomidine 0.5mcg/kg, Caffeine 15mg/kg, rectal Tylenol 30mg/kg | Drug | Caudal Infusion |
| Propofol, rocuronium, caffeine, Tylenol, bupivacainepropofol 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) | Drug | General anesthesia |
Primary outcome
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.
Time frame: 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.
Time frame: 24 hours post operative
heart rate <90.
5 secondary outcomes
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert B Bryskin, MD principal investigator
Nemours Children's Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine, Dexmedetomidine, Caffeine, Tylenol and Propofol, rocuronium, caffeine, Tylenol, bupivacaine in people with Inguinal Hernia, run by Nemours Children's Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Return to Baseline Respiratory Function. (time frame: Within 24 hours post operative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.