Foot Injury, Ankle Injury
Conditions
Keywords
Adult, nerve blocks in foot and ankle surgery, saphenous
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.
Interventions
PROCEDURESaphenous Nerve Block
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
Sponsors
Paul J. Juliano, M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| knee extensor strength measured in kilograms | change from baseline preoperatively to 30 minutes after nerve block placement | 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
| Measure | Time frame | Description |
|---|---|---|
| pain level | change from baseline preoperatively to two weeks post-operatively | Pain relief will be measured by review of the medical record for type and amount of pain medications used |
| quality of life assessment | change from baseline preoperatively to two weeks post-operatively | PROMIS Global Health Survey will be completed by patients in both treatment arms pre-operatively and again two weeks post-operatively |
Countries
United States
Outcome results
None listed