NCT02210429

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2009

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 6, 2014

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

July 29, 2015

Status Verified

June 1, 2015

Enrollment Period

5.4 years

First QC Date

August 3, 2014

Last Update Submit

July 27, 2015

Conditions

Acute PainPain, Postoperative

Keywords

Supraclavicular BlockSupraclavicular CatheterPediatric AnesthesiaRegional AnesthesiaSupracondylar Elbow Fracture

Outcome Measures

Primary Outcomes (1)

  • Post-operative opioid use

    Total doses

    24 hours

Secondary Outcomes (3)

  • Anti-emetic drug use

    24 hours

  • Incidence of nerve damage or compartment syndrome

    1 month

  • Pain Score

    24 hours

Study Arms (4)

IV Opioids

ACTIVE COMPARATOR
Procedure: Elbow Fracture Fixation

Supraclavicular Single-Shot Block

ACTIVE COMPARATOR
Procedure: Elbow Fracture Fixation

Supraclavicular Catheter

ACTIVE COMPARATOR
Procedure: Elbow Fracture Fixation

Supraclavicular Angiocath

ACTIVE COMPARATOR
Procedure: Elbow Fracture Fixation

Interventions

Elbow Fracture FixationPROCEDURE
IV OpioidsSupraclavicular AngiocathSupraclavicular CatheterSupraclavicular Single-Shot Block

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Incomplete or inaccessable chart data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Chicago, Illinois, 60611-2605, United States

Location

Related Publications (2)

  • 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.

    PMID: 20017868BACKGROUND

  • 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.

    PMID: 20670249BACKGROUND

MeSH Terms

Conditions

Acute PainPain, Postoperative

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Officials

  • Santhanam Suresh, MD

    Ann & Robert H Lurie Children's Hospital of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2014

First Posted

August 6, 2014

Study Start

January 1, 2009

Primary Completion

June 1, 2014

Study Completion

November 1, 2015

Last Updated

July 29, 2015

Record last verified: 2015-06

Locations

US(1)