Back to resultsIdeal Anatomic Location for Saphenous Nerve Blocks: A Prospective Clinical Evaluation
Primary Purpose
Foot Injury, Ankle Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Saphenous Nerve Block
Sponsored by
About this trial
This is an interventional treatment trial for Foot Injury focused on measuring Adult, nerve blocks in foot and ankle surgery, saphenous
Eligibility Criteria
Inclusion Criteria:
- Age 18-65
- Upcoming elective foot or ankle surgery
Exclusion Criteria:
- Preoperative weakness in knee extension
- Documented neuropathy
- Previous knee surgery
- Inability to provide informed consent
Sites / Locations
- Penn State Milton S. Hershey Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Proximal saphenous nerve block
Distal saphenous nerve block
Arm Description
The anesthesiologist will administer a saphenous proximal nerve block if specified in the randomization envelope.
The anesthesiologist will administer a saphenous distal nerve block if specified in the randomization envelope.
Outcomes
Primary Outcome Measures
knee extensor strength measured in kilograms
Strength of the knee extensors in both treatment arms (distal vs. proximal block) will be tested preoperatively and again 30 minutes after the nerve block by using a hand-held dynamometer measured in kilograms
Secondary Outcome Measures
pain level
Pain relief will be measured by review of the medical record for type and amount of pain medications used
quality of life assessment
PROMIS Global Health Survey will be completed by patients in both treatment arms pre-operatively and again two weeks post-operatively
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02645097
Brief Title
Ideal Anatomic Location for Saphenous Nerve Blocks: A Prospective Clinical Evaluation
Official Title
Ideal Anatomic Location for Saphenous Nerve Blocks: A Prospective Clinical Evaluation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Paul J. Juliano, M.D.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This research is being done to compare two different saphenous nerve block locations and will help to determine which site best maintains knee strength and pain control.
Detailed Description
This is a prospective, randomized, observer blinded clinical trial comparing motor strength in knee extension between two sets of patients, one receiving a proximal thigh block of the saphenous nerve and one receiving a distal thigh block of the saphenous nerve. The secondary objectives are to compare the pain relief and quality of life of participants in these two groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Injury, Ankle Injury
Keywords
Adult, nerve blocks in foot and ankle surgery, saphenous
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Proximal saphenous nerve block
Arm Type
Active Comparator
Arm Description
The anesthesiologist will administer a saphenous proximal nerve block if specified in the randomization envelope.
Arm Title
Distal saphenous nerve block
Arm Type
Active Comparator
Arm Description
The anesthesiologist will administer a saphenous distal nerve block if specified in the randomization envelope.
Intervention Type
Procedure
Intervention Name(s)
Saphenous Nerve Block
Intervention Description
A nerve block will be performed by the anesthesiologist. The location of the nerve block will be per randomization envelope (proximal vs. distal) and performed just prior to foot or ankle surgical procedures that require a saphenous nerve block
Primary Outcome Measure Information:
Title
knee extensor strength measured in kilograms
Description
Strength of the knee extensors in both treatment arms (distal vs. proximal block) will be tested preoperatively and again 30 minutes after the nerve block by using a hand-held dynamometer measured in kilograms
Time Frame
change from baseline preoperatively to 30 minutes after nerve block placement
Secondary Outcome Measure Information:
Title
pain level
Description
Pain relief will be measured by review of the medical record for type and amount of pain medications used
Time Frame
change from baseline preoperatively to two weeks post-operatively
Title
quality of life assessment
Description
PROMIS Global Health Survey will be completed by patients in both treatment arms pre-operatively and again two weeks post-operatively
Time Frame
change from baseline preoperatively to two weeks post-operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-65
Upcoming elective foot or ankle surgery
Exclusion Criteria:
Preoperative weakness in knee extension
Documented neuropathy
Previous knee surgery
Inability to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul J Juliano, M.D.
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ideal Anatomic Location for Saphenous Nerve Blocks: A Prospective Clinical Evaluation
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