Anesthesia, Caudal Clinical Trial
Official title:
Epidural Pressure Changes Following Caudal Blockade: A Prospective Observational Study
This study is a prospective study of epidural pressure changes when local anesthetic is injected from the caudal route. All patients will receive the same weight based volume dose of local anesthetic after induction of general anesthesia, and a CVP transducer will be attached to the standard caudal needle for measurement of pressure: under the skin, after entering the epidural space, and every 15 seconds for 3 minutes after completion of injection with the needle in situ. The placement of the caudal epidural will follow current standard of care and administration, the only variation will be the addition of a pressure transducer to the stopcock where the local anesthetic syringe is attached that will allow for pressure monitoring.
After approval of the Internal Review Board, the patients and families will be given the
opportunity to participate in the proposed research study if inclusion criteria are met. The
patient/family will sign the anesthesia consent form, as per protocol, by initialing the box
at the bottom that states 'I do want, if indicated, regional anesthetic techniques employed
for anesthetic maintenance and/or port operative pain relief for my child.' The primary
anesthesia team (anesthesiologist/CNRA/resident) will be made aware that the need for a
pressure transducer for the caudal epidural injection will be required and that a member of
the research team will be documenting pressures during the procedure. Premedication with
midazolam will be at the discretion of the attending anesthesiologist covering the case.
Anesthesia induction may be performed with either intravenous medications or mask inhalation
at the attending anesthesiologist's discretion; however no narcotics will be administered
during induction, as is common when a caudal epidural is utilized for post-operative pain
control. The airway will be secured using an oral endotracheal tube or laryngeal mask airway
(LMA).
The single shot caudal epidural block with pressure monitoring will be performed by one of
the study investigators. Ropivicaine/Bupivacaine 0.125-0.25% will be used as the local
anesthetic for the caudal epidural with a total dose not to exceed 1 ml/kg. Pressure
transduction will be constantly in place, with pressures being recorded by a research nurse:
1) prior to entering the epidural space, but after needle introduction under the skin, 2)
after loss of resistance upon entering the epidural space, 3) at 5 second intervals during
injection of the 1 mL/kg bolus of local anesthetic 4) continuing with pressure monitoring
for an additional minute, in 10 second increments, after the injection is completed.
Following placement of the block, a band-aidwill be placed, where appropriate, and the
patient will be prepped for the surgical procedure. The primary anesthesia team will
continue delivering the general anesthetic for the remainder of the case. Maintenance
anesthesia will be carried out per our usual routine.
Upon completion of the surgical procedure, the patient's airway device will be removed and
the patient will be transferred to the post-anesthesia care unit (PACU). In the PACU, the
principal or co-investigator will review the patient's treatment needs for pain in the PACU
to determine whether the block was efficacious; fentanyl 0.5 µg/kg, or the
morphine-equivalent dose, will be administered as necessary based on the pain assessment.
The patients will be discharged from PACU when discharge criteria are met per the Aldrete
score.
;
Observational Model: Case-Only, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05133687 -
The Hemodynamic Effects of Different Volumes of Bupivacaine 0.25% Caudal Blocks in Pediatrics Undergoing Lower Abdominal Surgeries as Measured by Electrical Cardiometry
|
Phase 3 | |
| Completed |
NCT01107873 -
Changes of Dorsalis Pedis Artery Flow Pattern After Caudal Block in Children: Observational Study Using a Duplex Sonography
|
N/A | |
| Completed |
NCT01869036 -
Use of Caudal Anesthesia Supplemented With Morphine in Children Undergoing Renal Surgery
|
Phase 4 | |
| Completed |
NCT05581940 -
Pediatric Caudal Anesthesia Block. And Pain Control
|
||
| Completed |
NCT03825172 -
Evaluation Of Caudal Epidural Anatomy By Ultrasonography İn Pediatric Patients
|
||
| Not yet recruiting |
NCT06203743 -
Evaluation of Caudal Block and Ilioinguinal-ilioohypogastric Nerve Block Efficacy With Perfusion Index (PI)
|
N/A | |
| Completed |
NCT04491032 -
Pediatric Caudal Injection Volume on Optic Nerve Sheath Diameter and Cerebral Oxygenation
|
N/A | |
| Completed |
NCT04590027 -
Caudal Block Versus Local Wound Infiltration for Inguinal Procedures
|