A Study Comparing Continuous Sciatic Nerve Block to Single Shot Sciatic Nerve Block

This study has been terminated.
(The study has been terminiated due to minimal subject recruitment)
Sponsor:
Information provided by (Responsible Party):
Antoun Nader, Northwestern University
ClinicalTrials.gov Identifier:
NCT01615939
First received: June 7, 2012
Last updated: May 23, 2016
Last verified: May 2016
Results First Received: May 23, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Condition: Fracture of Foot
Interventions: Drug: Bupivacaine
Drug: Ropivacaine

  Participant Flow
  Hide Participant Flow

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
Single Shot Sciatic Nerve Block

Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml).

Bupivacaine: Bupivacaine 0.625% with epinephrine 1:300,000

Continuous Sciatic Nerve Block

Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves.

Ropivacaine: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr.


Participant Flow:   Overall Study
    Single Shot Sciatic Nerve Block     Continuous Sciatic Nerve Block  
STARTED     13     4  
COMPLETED     8     4  
NOT COMPLETED     5     0  
Lost to Follow-up                 5                 0  



  Baseline Characteristics
  Hide Baseline Characteristics

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
Single Shot Sciatic Nerve Block

Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml).

Bupivacaine: Bupivacaine 0.625% with epinephrine 1:300,000

Continuous Sciatic Nerve Block

Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves.

Ropivacaine: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr.

Total Total of all reporting groups

Baseline Measures
    Single Shot Sciatic Nerve Block     Continuous Sciatic Nerve Block     Total  
Number of Participants  
[units: participants]
  8     4     12  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     5     3     8  
>=65 years     3     1     4  
Age  
[units: years]
Median (Inter-Quartile Range)
  48  
  (33 to 73)  
  41  
  (30 to 61)  
  41  
  (33 to 70)  
Gender  
[units: participants]
     
Female     3     1     4  
Male     5     3     8  
Region of Enrollment  
[units: participants]
     
United States     8     4     12  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Temporary Neurologic Symptoms Between Groups   [ Time Frame: 1 month ]

2.  Secondary:   Participant Satisfaction With Anesthesia   [ Time Frame: 24 hours ]

3.  Secondary:   Pain Control   [ Time Frame: 72 hrs ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
Early termination leading to small numbers of subjects analyzed


  More Information
  Hide More Information

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


Results Point of Contact:  
Name/Title: Antoun Nader
Organization: Northwestern University, Feinberg School of Medicine
phone: 312-695-3045
e-mail: a-nader2@northwestern.edu



Responsible Party: Antoun Nader, Northwestern University
ClinicalTrials.gov Identifier: NCT01615939     History of Changes
Other Study ID Numbers: STU00058306
Study First Received: June 7, 2012
Results First Received: May 23, 2016
Last Updated: May 23, 2016
Health Authority: United States: Institutional Review Board