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Retrospective Femoral Nerve Block Study

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ClinicalTrials.gov Identifier: NCT01293136
Recruitment Status : Completed
First Posted : February 10, 2011
Last Update Posted : January 31, 2012
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital

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.

Condition or disease Intervention/treatment
Other Reconstructive Surgery Procedure: Femoral nerve block Drug: Intravenous opioids

Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Retrospective
Study Start Date : February 2011
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
intravenous opioids Drug: Intravenous opioids
Whatever opioids prescribed
femoral nerve block Procedure: Femoral nerve block

Primary Outcome Measures :
  1. 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 :
  1. Nausea and vomiting [ Time Frame: 1 Week ]
  2. Total opioid use [ Time Frame: 1 Week ]
  3. Postoperative pain score [ Time Frame: 1 Week ]

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

Inclusion Criteria:

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

Exclusion Criteria:

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

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

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 Posted: February 10, 2011    Key Record Dates
Last Update Posted: January 31, 2012
Last Verified: January 2012

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

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