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

Primary Purpose

Acute Pain, Pain, Postoperative

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Elbow Fracture Fixation
Sponsored by
Ann & Robert H Lurie Children's Hospital of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain focused on measuring Supraclavicular Block, Supraclavicular Catheter, Pediatric Anesthesia, Regional Anesthesia, Supracondylar Elbow Fracture

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Incomplete or inaccessable chart data

Sites / Locations

  • Ann & Robert H. Lurie Children's Hospital of Chicago

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

IV Opioids

Supraclavicular Single-Shot Block

Supraclavicular Catheter

Supraclavicular Angiocath

Arm Description

Outcomes

Primary Outcome Measures

Post-operative opioid use
Total doses

Secondary Outcome Measures

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

Full Information

First Posted
August 3, 2014
Last Updated
July 27, 2015
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT02210429
Brief Title
Supraclavicular Blocks for Post-Operative Pain Control in Supracondylar Fracture Fixation, a Retrospective Analysis of Single Shot Catheter Techniques
Official Title
Supraclavicular Blocks for Post-Operative Pain Control in Supracondylar Fracture Fixation, a Retrospective Analysis of Single Shot Catheter Techniques
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
November 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain, Pain, Postoperative
Keywords
Supraclavicular Block, Supraclavicular Catheter, Pediatric Anesthesia, Regional Anesthesia, Supracondylar Elbow Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IV Opioids
Arm Type
Active Comparator
Arm Title
Supraclavicular Single-Shot Block
Arm Type
Active Comparator
Arm Title
Supraclavicular Catheter
Arm Type
Active Comparator
Arm Title
Supraclavicular Angiocath
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Elbow Fracture Fixation
Primary Outcome Measure Information:
Title
Post-operative opioid use
Description
Total doses
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Anti-emetic drug use
Description
Total doses
Time Frame
24 hours
Title
Incidence of nerve damage or compartment syndrome
Description
Evaluated by surgeon at follow up.
Time Frame
1 month
Title
Pain Score
Description
Using Visual Analog Scale and FLACC pain scale (for younger children) we will compare pain scores in the various groups.
Time Frame
24 hours

10. Eligibility

Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age under 18 Undergoing supracondylar fracture fixation in operating room Exclusion Criteria: Incomplete or inaccessable chart data
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Santhanam Suresh, MD
Organizational Affiliation
Ann & Robert H Lurie Children's Hospital of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ann & Robert H. Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-2605
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20017868
Citation
Suresh S, Sarwark JP, Bhalla T, Janicki J. Performing US-guided nerve blocks in the postanesthesia care unit (PACU) for upper extremity fractures: is this feasible in children? Paediatr Anaesth. 2009 Dec;19(12):1238-40. doi: 10.1111/j.1460-9592.2009.03182.x. No abstract available.
Results Reference
background
PubMed Identifier
20670249
Citation
Steinfeldt J, Robison T, Przybylo HJ. Placement of an US-guided supraclavicular block postoperatively in children: can we make this easy? Paediatr Anaesth. 2010 Aug;20(8):780-1. doi: 10.1111/j.1460-9592.2010.03355.x. No abstract available.
Results Reference
background

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

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