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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01293136
Other study ID # IRB11-00073
Secondary ID
Status Completed
Phase N/A
First received February 9, 2011
Last updated January 27, 2012
Start date February 2011
Est. completion date December 2011

Study information

Verified date January 2012
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 400
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients that had reconstructive knee surgery between July 2009 to the present.

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Procedure:
Femoral nerve block
Ropivacaine
Drug:
Intravenous opioids
Whatever opioids prescribed

Locations

Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Duration of hospitalization duration of hospitalization and need for inpatient admission in patients who received femoral nerve block versus those who received intravenous opioids 1 Week No
Secondary Nausea and vomiting 1 Week No
Secondary Total opioid use 1 Week No
Secondary Postoperative pain score 1 Week No
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