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Evaluation of Continuous Saphenous Nerve Block to Supplement a Continuous Sciatic Nerve Block After Ankle Surgery

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ClinicalTrials.gov Identifier: NCT01167907
Recruitment Status : Completed
First Posted : July 22, 2010
Results First Posted : December 8, 2017
Last Update Posted : December 8, 2017
Sponsor:
Collaborator:
I-Flow
Information provided by (Responsible Party):
Robert Weller, M.D., Wake Forest University Health Sciences

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Orthopedic Surgery of Lower Extremity
Interventions: Drug: 0.2% ropivacaine
Drug: saline

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
0.2% Ropivacaine Patients with evidence of sciatic and saphenous nerve block will be administered 0.2% ropivacaine by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.
Saline Patients with evidence of sciatic and saphenous nerve block will be administered saline by elastomeric infusion pump at 5ml/h via the saphenous catheter started within 6h of catheter placement in addition to the sciatic catheter infusion of 0.2% ropivacaine at 10mL/hr.

Participant Flow:   Overall Study
    0.2% Ropivacaine   Saline
STARTED   17   15 
COMPLETED   15   14 
NOT COMPLETED   2   1 
Protocol Violation                1                0 
saphenous catheter dislodged before comp                1                1 



  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.
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Reporting Groups
  Description
0.2% Ropivacaine

Patients with evidence of sciatic and saphenous nerve block will be randomized to receive a postoperative continuous infusion of either saline (control) or 0.2% ropivacaine by elastomeric infusion pump at 5ml/h started within 6h of catheter placement.

0.2% ropivacaine: 0.2% ropivacaine by elastomeric infusion pump at 5ml/h started within 6h of catheter placement

saline: saline (control) by elastomeric infusion pump at 5ml/h started within 6h of catheter placement

Saline

Patients with evidence of sciatic and saphenous nerve block will be randomized to receive a postoperative continuous infusion of either saline (control) or 0.2% ropivacaine by elastomeric infusion pump at 5ml/h started within 6h of catheter placement.

saline: saline (control) by elastomeric infusion pump at 5ml/h started within 6h of catheter placement

Total Total of all reporting groups

Baseline Measures
   0.2% Ropivacaine   Saline   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   15   32 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.6  (12.4)   47.9  (16.8)   49.8  (14.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      12  70.6%      6  40.0%      18  56.3% 
Male      5  29.4%      9  60.0%      14  43.8% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      3  17.6%      3  20.0%      6  18.8% 
White      14  82.4%      12  80.0%      26  81.3% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   17   15   32 


  Outcome Measures

1.  Primary:   Verbal Pain Scores   [ Time Frame: 48 hours post nerve blockade ]

2.  Secondary:   Opioid Use   [ Time Frame: 48 hours post nerve blockade ]

3.  Secondary:   Nausea   [ Time Frame: 48 hours post nerve blockade ]

4.  Secondary:   Vomiting   [ Time Frame: 48 hour post nerve blockade ]

5.  Secondary:   Sleep Disturbance   [ Time Frame: 48 hours post nerve blockade ]

6.  Secondary:   Reduction of Quadriceps Strength   [ Time Frame: 24 hours post nerve blockade ]


  Serious Adverse Events


  Other Adverse Events


  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
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  More Information

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


Results Point of Contact:  
Name/Title: Robert S. Weller, MD
Organization: Wake Forest School of Medicine
phone: 336-716-7150
e-mail: rweller@wakehealth.edu



Responsible Party: Robert Weller, M.D., Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01167907     History of Changes
Other Study ID Numbers: Protocol WFUHS 00013823
First Submitted: July 21, 2010
First Posted: July 22, 2010
Results First Submitted: September 7, 2017
Results First Posted: December 8, 2017
Last Update Posted: December 8, 2017