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

NCT02233309 | Completed Results

• 1 other identifier: IRB14-00119
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia, Caudal

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Monitoring of pressures during caudal anesthesia

Patients receiving caudal anesthesia as standard of care for a surgical procedure. Our study adds a monitoring line to the needle for the caudal. The caudal itself is not part of the study.

Other: Monitoring of pressures during caudal anesthesia

Interventions

Monitoring of pressures during caudal anesthesia OTHER

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.

Monitoring of pressures during caudal anesthesia

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who will be receiving caudal anesthesia as part of their surgical procedure.

You may qualify if:

• ASA physical status I or II
• Weight ≥ 3 kilograms
• Undergoing a lower abdominal/pelvic or urologic procedure where caudal epidural anesthesia is a beneficial adjunct

You may not qualify if:

• Co-morbid diseases (cardiac, pulmonary, neurological disease)
• Patients with sacral deformities contraindicating a caudal epidural
• Use of therapeutic dose anticoagulants or presence of a bleeding disorder
• Other co-existing conditions would preclude the use of neuraxial blockade

Sponsors & Collaborators

• Jessica Goeller: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Results Point of Contact

• Title: Jessica K. Goeller, DO
• Organization: University of Nebraska Children's Hospital & Medical Center

JGoeller@childrensOmaha.org

(402) 955-4303

Study Officials

• Jessica Goeller, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anesthesiology Fellow

Study Record Dates

• First Submitted: August 1, 2014
• First Posted: September 8, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: May 28, 2015
• Results First Posted: May 28, 2015

Record last verified: 2015-05

Locations

US (1)