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Retrospective Femoral Nerve Block Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01293136
First Posted: February 10, 2011
Last Update Posted: January 31, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital
  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.

Condition Intervention
Other Reconstructive Surgery Procedure: Femoral nerve block Drug: Intravenous opioids

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by Joseph D. Tobias, Nationwide Children's Hospital:

Primary Outcome Measures:
  • Duration of hospitalization [ Time Frame: 1 Week ]
    duration of hospitalization and need for inpatient admission in patients who received femoral nerve block versus those who received intravenous opioids


Secondary Outcome Measures:
  • Nausea and vomiting [ Time Frame: 1 Week ]
  • Total opioid use [ Time Frame: 1 Week ]
  • Postoperative pain score [ Time Frame: 1 Week ]

Enrollment: 400
Study Start Date: February 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
intravenous opioids Drug: Intravenous opioids
Whatever opioids prescribed
femoral nerve block Procedure: Femoral nerve block
Ropivacaine

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients that had reconstructive knee surgery
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01293136


Locations
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
  More Information

Responsible Party: Joseph D. Tobias, Chairman Dept. of Anesthesiology & Pain Medicine, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01293136     History of Changes
Other Study ID Numbers: IRB11-00073
First Submitted: February 9, 2011
First Posted: February 10, 2011
Last Update Posted: January 31, 2012
Last Verified: January 2012

Keywords provided by Joseph D. Tobias, Nationwide Children's Hospital:
knee
reconstructive surgery
femoral nerve block

Additional relevant MeSH terms:
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents