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Regional Anesthesia for Sickle Cell Crisis Using Ultrasound in The Emergency Department: Phase I (RESCUED)

This study has been terminated.
(lack of resources)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01256281
First Posted: December 8, 2010
Last Update Posted: April 23, 2015
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):
Icahn School of Medicine at Mount Sinai
Results First Submitted: December 2, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Sickle Cell Disease
Intervention: Procedure: Femoral Nerve Block

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Femoral Nerve Block Patients enrolled will receive ultrasound guided FNB in addition to standard care. If subjects are experiencing pain in both lower extremities, both extremities will be blocked; if subjects are experiencing pain in one lower extremity, only the affected extremity will be blocked.

Participant Flow:   Overall Study
    Femoral Nerve Block
STARTED   2 
COMPLETED   2 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Femoral Nerve Block Patients enrolled will receive ultrasound guided FNB in addition to standard care. If subjects are experiencing pain in both lower extremities, both extremities will be blocked; if subjects are experiencing pain in one lower extremity, only the affected extremity will be blocked.

Baseline Measures
   Femoral Nerve Block 
Overall Participants Analyzed 
[Units: Participants]
 2 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   2 
>=65 years   0 
Gender 
[Units: Participants]
 
Female   1 
Male   1 


  Outcome Measures

1.  Primary:   Pain Score in Legs (0-10)   [ Time Frame: 2-4 hours after intervention ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
study was terminated due to lack of resources. no data analysis for this study.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Jeffrey Glassberg
Organization: Icahn School of Medicine at Mount Sinai
phone: (212) 824-8056
e-mail: jeffrey.glassberg@mountsinai.org



Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01256281     History of Changes
Other Study ID Numbers: 10-0934
First Submitted: December 7, 2010
First Posted: December 8, 2010
Results First Submitted: December 2, 2013
Results First Posted: April 23, 2015
Last Update Posted: April 23, 2015