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

Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago (Other)
Overall Status
Unknown status
CT.gov ID
NCT02210429
Collaborator
(none)
200
Enrollment
1
Location
4
Arms
82
Duration (Months)
2.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Elbow Fracture Fixation
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Non-Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Supraclavicular Blocks for Post-Operative Pain Control in Supracondylar Fracture Fixation, a Retrospective Analysis of Single Shot Catheter Techniques
Study Start Date :
Jan 1, 2009
Actual Primary Completion Date :
Jun 1, 2014
Anticipated Study Completion Date :
Nov 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Post-operative opioid use [24 hours]

    Total doses

Secondary Outcome Measures

  1. Anti-emetic drug use [24 hours]

    Total doses

  2. Incidence of nerve damage or compartment syndrome [1 month]

    Evaluated by surgeon at follow up.

  3. Pain Score [24 hours]

    Using Visual Analog Scale and FLACC pain scale (for younger children) we will compare pain scores in the various groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Age under 18

  • Undergoing supracondylar fracture fixation in operating room

Exclusion Criteria:
  • Incomplete or inaccessable chart data

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois United States 60611-2605

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT02210429
Other Study ID Numbers:
  • 2014-15849
First Posted:
Aug 6, 2014
Last Update Posted:
Jul 29, 2015
Last Verified:
Jun 1, 2015
Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago
Supraclavicular Block
Supraclavicular Catheter
Pediatric Anesthesia
Regional Anesthesia
Supracondylar Elbow Fracture
Additional relevant MeSH terms:
Pain, Postoperative
Acute Pain

Study Results

No Results Posted as of Jul 29, 2015