Does Ultrasound Improve Procedural Time in the Lateral Popliteal Approach to the Sciatic Nerve in Obese Patients

This study has been completed.
Sponsor:
Collaborator:
VA Palo Alto Health Care System
Information provided by (Responsible Party):
Nicholas Lam, University of New Mexico
ClinicalTrials.gov Identifier:
NCT01579747
First received: April 16, 2012
Last updated: December 18, 2013
Last verified: December 2013
Results First Received: August 19, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Postoperative Pain
Interventions: Procedure: Ultrasound
Procedure: Nerve stimulation

  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
Patients recruited in UNMH and outpatient's surgical center

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1 excluded because not meeting inclusion criteria. Patient lost weight prior to surgery

Reporting Groups
  Description
Nerve Stimulation Sciatic Nerve Block Sciatic nerve block performed with nerve stimulation
Ultrasound Guided Sciatic Nerve Block Sciatic nerve block performed with ultrasound guidance

Participant Flow:   Overall Study
    Nerve Stimulation Sciatic Nerve Block     Ultrasound Guided Sciatic Nerve Block  
STARTED     12     12  
COMPLETED     12     12  
NOT COMPLETED     0     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
Nerve Stimulation Sciatic Nerve Block Sciatic nerve block performed with nerve stimulation
Ultrasound Guided Sciatic Nerve Block Sciatic nerve block performed with ultrasound guidance
Total Total of all reporting groups

Baseline Measures
    Nerve Stimulation Sciatic Nerve Block     Ultrasound Guided Sciatic Nerve Block     Total  
Number of Participants  
[units: participants]
  12     12     24  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     12     11     23  
>=65 years     0     1     1  
Age  
[units: years]
Mean ± Standard Deviation
  49.3  ± 14.3     58.0  ± 9.4     53.65  ± 11.85  
Gender  
[units: participants]
     
Female     5     7     12  
Male     7     5     12  
Region of Enrollment  
[units: participants]
     
United States     12     12     24  



  Outcome Measures
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1.  Primary:   Procedural Time   [ Time Frame: less than 30 minutes ]

2.  Secondary:   Number of Redirections   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
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
We attempted to minimize performance bias by only involving staff anesthesiologists with years of experience in peripheral nerve blockade using both guidance modalities.  


Results Point of Contact:  
Name/Title: Nicholas Lam
Organization: Univeristy of New Mexico
phone: 505 272 2610
e-mail: nlam@salud.unm.edu


No publications provided


Responsible Party: Nicholas Lam, University of New Mexico
ClinicalTrials.gov Identifier: NCT01579747     History of Changes
Other Study ID Numbers: UNMLAM_USvsNSobese
Study First Received: April 16, 2012
Results First Received: August 19, 2013
Last Updated: December 18, 2013
Health Authority: United States: Institutional Review Board