Ideal Anatomic Location for Saphenous Nerve Blocks: A Prospective Clinical Evaluation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Ideal Anatomic Location for Saphenous Nerve Blocks: A Prospective Clinical Evaluation

Conditions
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Foot Injury, Ankle Injury

Intervention / Treatment
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* Procedure: Saphenous Nerve Block


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Proximal saphenous nerve block<br>The anesthesiologist will administer a saphenous proximal nerve block if specified in the randomization envelope. | Procedure: Saphenous Nerve Block<br>* 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<br>|
| Active Comparator: Distal saphenous nerve block<br>The anesthesiologist will administer a saphenous distal nerve block if specified in the randomization envelope. | Procedure: Saphenous Nerve Block<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | change from baseline preoperatively to 30 minutes after nerve block placement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain level | Pain relief will be measured by review of the medical record for type and amount of pain medications used | change from baseline preoperatively to two weeks post-operatively | 
| 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 | change from baseline preoperatively to two weeks post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adult, nerve blocks in foot and ankle surgery, saphenous