A Prospective Observational Study of Epidural Pressures During Caudal Epidural in the Pediatric Population

Anesthesia, Caudal Clinical Trial

Official title:

Epidural Pressure Changes Following Caudal Blockade: A Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02233309
• Other study ID #: IRB14-00119
• Status: Completed
• Phase: N/A
• First received: August 1, 2014
• Last updated: May 13, 2015
• Start date: April 2014
• Est. completion date: September 2014

Study information

• Verified date: May 2015
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. ASA physical status I or II

2. Weight = 3 kilograms

3. Undergoing a lower abdominal/pelvic or urologic procedure where caudal epidural anesthesia is a beneficial adjunct

Exclusion Criteria:

1. Co-morbid diseases (cardiac, pulmonary, neurological disease)

2. Patients with sacral deformities contraindicating a caudal epidural

3. Use of therapeutic dose anticoagulants or presence of a bleeding disorder

4. Other co-existing conditions would preclude the use of neuraxial blockade

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anesthesia, Caudal

Intervention

Other:
• Monitoring of pressures during caudal anesthesia
The caudal itself is a separate procedure not covered by this observational study. This study simply attaches a monitoring device to the needle used for the caudal to measure pressures. The caudal takes place whether the observation of pressures is agreed to or not, as per standard protocol.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Jessica Goeller

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure in the Caudal Epidural Space	After administration of the single-shot bolus dose of the local anesthetic agent (1 mL/kg), the immediate post-bolus pressure was measured.	Immediately post bolus	No