NCT01930201

Brief Summary

This retrospective chart review will demonstrate the feasibility of performing caudal epidural blockade in adolescents undergoing major orthopedic hip surgery and provide information regarding the feasibility of this technique's use on a regular basis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 9, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 28, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

October 29, 2014

Status Verified

October 1, 2014

Enrollment Period

6 months

First QC Date

July 9, 2013

Last Update Submit

October 28, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain

    Assessing pain scores post-operatively.

    During 1st 24 hours post-op

Secondary Outcomes (2)

  • Pain medication requirement

    During 1st 24 hours post-op

  • Antiemetic medication requirement

    During 1st 24 hours post-op

Study Arms (2)

Standard general anesthesia

Patients receiving standard of care.

Other: General anesthesia

Caudal Epidural Block

Patients receiving a caudal epidural block in addition to standard of care.

Procedure: Caudal epidural blockOther: General anesthesia

Interventions

Caudal Epidural Block
Caudal Epidural BlockStandard general anesthesia

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who had major orthopedic hip surgery.

You may qualify if:

  • Adolescents that underwent major orthopedic hip surgery.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Interventions

Anesthesia, General

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

July 9, 2013

First Posted

August 28, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

October 29, 2014

Record last verified: 2014-10

Locations