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

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.

Study Overview

• Status: Completed
• Conditions: Ankle Injury; Foot Injury
• Intervention / Treatment: Procedure: Saphenous Nerve Block

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S. Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Proximal saphenous nerve block; The anesthesiologist will administer a saphenous proximal nerve block if specified in the randomization envelope.	Procedure: Saphenous 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
Active Comparator: Distal saphenous nerve block; The anesthesiologist will administer a saphenous distal nerve block if specified in the randomization envelope.	Procedure: Saphenous 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Paul J. Juliano, M.D.
• Investigators: Principal Investigator: Paul J Juliano, M.D., Milton S. Hershey Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: December 28, 2015
• First Submitted That Met QC Criteria: December 30, 2015
• First Posted (Estimate): January 1, 2016

Study Record Updates

• Last Update Posted (Actual): June 25, 2019
• Last Update Submitted That Met QC Criteria: June 21, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Adult; saphenous; nerve blocks in foot and ankle surgery
• Additional Relevant MeSH Terms: Leg Injuries; Wounds and Injuries; Ankle Injuries; Foot Injuries
• Other Study ID Numbers: IRB - 39025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No