Supraclavicular Blocks for Post-Operative Pain Control in Supracondylar Fracture Fixation, a Retrospective Analysis of Single Shot Catheter Techniques

July 27, 2015 updated by: Ann & Robert H Lurie Children's Hospital of Chicago
We hypothesize that patients who receive a supraclavicular block via Angiocath, placed intra-operatively and dosed post-operatively following neurologic examination, will have lower pain scores, lower use of intravenous morphine equivalents in the post-anesthesia care unit, and lower rates of intervention for post-operative nausea and vomiting. We also hypothesize that patients receiving this nerve block had the same rates of nerve damage as the patients who did not receive a block and that there will be no demonstrable safety concerns with this block.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611-2605
        • Ann & Robert H. Lurie Children's Hospital of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age under 18
  • Undergoing supracondylar fracture fixation in operating room

Exclusion Criteria:

  • Incomplete or inaccessable chart data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: IV Opioids
Procedure: Elbow Fracture Fixation
Active Comparator: Supraclavicular Single-Shot Block
Procedure: Elbow Fracture Fixation
Active Comparator: Supraclavicular Catheter
Procedure: Elbow Fracture Fixation
Active Comparator: Supraclavicular Angiocath
Procedure: Elbow Fracture Fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative opioid use
Time Frame: 24 hours
Total doses
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-emetic drug use
Time Frame: 24 hours
Total doses
24 hours
Incidence of nerve damage or compartment syndrome
Time Frame: 1 month
Evaluated by surgeon at follow up.
1 month
Pain Score
Time Frame: 24 hours
Using Visual Analog Scale and FLACC pain scale (for younger children) we will compare pain scores in the various groups.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Investigators

  • Principal Investigator: Santhanam Suresh, MD, Ann & Robert H Lurie Children's Hospital of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

June 1, 2014

Study Completion (Anticipated)

November 1, 2015

Study Registration Dates

First Submitted

August 3, 2014

First Submitted That Met QC Criteria

August 4, 2014

First Posted (Estimate)

August 6, 2014

Study Record Updates

Last Update Posted (Estimate)

July 29, 2015

Last Update Submitted That Met QC Criteria

July 27, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-15849

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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