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

Foot Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02645097
• Other study ID #: IRB - 39025
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: December 2016

Study information

• Verified date: June 2019
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Injury
• Foot Injuries
• Foot Injury
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Paul J. Juliano, M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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