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Retrospective Femoral Nerve Block Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01293136
First received: February 9, 2011
Last updated: January 27, 2012
Last verified: January 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • Duration of hospitalization [ Time Frame: 1 Week ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Total opioid use [ Time Frame: 1 Week ] [ Designated as safety issue: No ]
  • Postoperative pain score [ Time Frame: 1 Week ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01293136

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

No publications provided

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
Study First Received: February 9, 2011
Last Updated: January 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Nationwide Children's Hospital:
knee
reconstructive surgery
femoral nerve block

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

ClinicalTrials.gov processed this record on May 19, 2013