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

Not Applicable

Completed

• Conditions: Ankle Injury; Foot Injury

• Registration Number: NCT02645097
• Lead Sponsor: Paul J. Juliano, M.D.

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2015-12-28
• Study First Submitted QC: 2015-12-30
• Study First Posted: 2016-01-01
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-21
• Last Update Posted: 2019-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Penn State Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States