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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02210429
Other study ID # 2014-15849
Secondary ID
Status Active, not recruiting
Phase N/A
First received August 3, 2014
Last updated July 27, 2015
Start date January 2009
Est. completion date November 2015

Study information

Verified date June 2015
Source Ann & Robert H Lurie Children's Hospital of Chicago
Contact n/a
Is FDA regulated No
Health authority United States: Ann & Robert H. Lurie Children's Hospital of Chicago Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 200
Est. completion date November 2015
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group N/A to 17 Years
Eligibility Inclusion Criteria:

- Age under 18

- Undergoing supracondylar fracture fixation in operating room

Exclusion Criteria:

- Incomplete or inaccessable chart data

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Elbow Fracture Fixation


Locations

Country Name City State
United States Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Post-operative opioid use Total doses 24 hours No
Secondary Anti-emetic drug use Total doses 24 hours No
Secondary Incidence of nerve damage or compartment syndrome Evaluated by surgeon at follow up. 1 month No
Secondary Pain Score Using Visual Analog Scale and FLACC pain scale (for younger children) we will compare pain scores in the various groups. 24 hours No
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