Awake Caudal Catheter vs General Anesthesia

NCT05919732 | Completed Phase 4 Results DMC

• 1 other identifier: 16-03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (5)

• Days to Hospital Discharge From Surgery

  up to 10 days

• 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

• Number of Participants Returning to Full Feeds.

  Within 24 hours post operative

Study Arms (2)

Caudal Infusion

EXPERIMENTAL

Awake continuous caudal infusion.

Drug: Bupivacaine, Dexmedetomidine, Caffeine, Tylenol

General anesthesia

ACTIVE COMPARATOR

General anesthesia and single-dose caudal injection

Drug: Propofol, rocuronium, caffeine, Tylenol, bupivacaine

Interventions

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

Caudal Infusion

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)

General anesthesia

Eligibility Criteria

• Age: 23 Weeks - 60 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nemours Children's Clinic: lead

Study Sites (1)

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Bupivacaine; Dexmedetomidine; Caffeine; Acetaminophen; Propofol; Rocuronium

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Xanthines; Alkaloids; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Acetanilides; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Gohalem Felema
• Organization: Nemours

gohalem.felema@nemours.org

904-416-5430

Study Officials

• Robert B Bryskin, MD

  Nemours Children's Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Model Details: A prospective, blinded, randomized controlled trial

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: June 26, 2023
• Study Start: March 8, 2016
• Primary Completion: March 8, 2018
• Study Completion: March 8, 2018
• Last Updated: April 2, 2024
• Results First Posted: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)