Expired Study
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Columbus, Ohio 43205


Purpose:

This is a retrospective review to evaluate the efficacy of femoral nerve block in providing analgesia following reconstructive surgery of the knee and to compare the postoperative course of patients who received femoral nerve block with a retrospective cohort who were cared for prior to the institution of a regional anesthesia program. The investigators hypothesize that femoral nerve blockade limits postoperative opioid needs, improves analgesia and facilitates discharge home when compared to intravenous opioid use following reconstructive knee surgery.


Criteria:

Inclusion Criteria: - Patients that had reconstructive knee surgery between July 2009 to the present. Exclusion Criteria: - None


Study is Available At:


Original ID:

IRB11-00073


NCT ID:

NCT01293136


Secondary ID:


Study Acronym:


Brief Title:

Retrospective Femoral Nerve Block Study


Official Title:


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Nationwide Children's Hospital


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: R


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

400


Enrollment Type:

Actual


Study Dates

Start Date:February 2011
Completion Date:December 2011
Completion Type:Actual
Primary Completion Date:December 2011
Primary Completion Type:Actual
Verification Date:January 2012
Last Changed Date:January 27, 2012
First Received Date:February 9, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure:Duration of hospitalization
Time Frame:1 Week
Safety Issues:False
Description:duration of hospitalization and need for inpatient admission in patients who received femoral nerve block versus those who received intravenous opioids
Outcome Type:Secondary Outcome
Measure:Nausea and vomiting
Time Frame:1 Week
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Total opioid use
Time Frame:1 Week
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Postoperative pain score
Time Frame:1 Week
Safety Issues:False

Study Interventions

Intervention Type:Procedure
Name:Femoral nerve block
Description:Ropivacaine
Arm Name:femoral nerve block
Intervention Type:Drug
Name:Intravenous opioids
Description:Whatever opioids prescribed
Arm Name:intravenous opioids

Study Arms

Study Arm Type:Other
Arm Name:femoral nerve block
Study Arm Type:Other
Arm Name:intravenous opioids

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Nationwide Children's Hospital

Samples and Retentions

Study Population: Patients that had reconstructive knee surgery
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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