NCT02645097

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

June 25, 2019

Status Verified

June 1, 2019

Enrollment Period

2.4 years

First QC Date

December 28, 2015

Last Update Submit

June 21, 2019

Conditions

Foot InjuryAnkle Injury

Keywords

Adultnerve blocks in foot and ankle surgerysaphenous

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • pain level

    change from baseline preoperatively to two weeks post-operatively

  • quality of life assessment

    change from baseline preoperatively to two weeks post-operatively

Study Arms (2)

Proximal saphenous nerve block

ACTIVE COMPARATOR

The anesthesiologist will administer a saphenous proximal nerve block if specified in the randomization envelope.

Procedure: Saphenous Nerve Block

Distal saphenous nerve block

ACTIVE COMPARATOR

The anesthesiologist will administer a saphenous distal nerve block if specified in the randomization envelope.

Procedure: Saphenous Nerve Block

Interventions

Saphenous Nerve BlockPROCEDURE

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

Distal saphenous nerve blockProximal saphenous nerve block

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65
  • Upcoming elective foot or ankle surgery

You may not qualify if:

  • Preoperative weakness in knee extension
  • Documented neuropathy
  • Previous knee surgery
  • Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Foot InjuriesAnkle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Paul J Juliano, M.D.

    Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Orthopaedic Surgery

Study Record Dates

First Submitted

December 28, 2015

First Posted

January 1, 2016

Study Start

July 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

June 25, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)