NCT01293136

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 31, 2012

Status Verified

January 1, 2012

Enrollment Period

10 months

First QC Date

February 9, 2011

Last Update Submit

January 27, 2012

Conditions

Other Reconstructive Surgery

Keywords

kneereconstructive surgeryfemoral nerve block

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Nausea and vomiting

    1 Week

  • Total opioid use

    1 Week

  • Postoperative pain score

    1 Week

Study Arms (2)

intravenous opioids

Drug: Intravenous opioids

femoral nerve block

Procedure: Femoral nerve block

Interventions

Femoral nerve blockPROCEDURE

Ropivacaine

femoral nerve block
Intravenous opioidsDRUG

Whatever opioids prescribed

intravenous opioids

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients that had reconstructive knee surgery

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman Dept. of Anesthesiology & Pain Medicine

Study Record Dates

First Submitted

February 9, 2011

First Posted

February 10, 2011

Study Start

February 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

January 31, 2012

Record last verified: 2012-01

Locations

US(1)