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

NCT ID: NCT02645097

Last Updated: 2019-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Foot Injury Ankle Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Proximal saphenous nerve block

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

Group Type ACTIVE_COMPARATOR

Saphenous Nerve Block

Intervention Type PROCEDURE

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 block

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

Group Type ACTIVE_COMPARATOR

Saphenous Nerve Block

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Paul J. Juliano, M.D.

OTHER

Sponsor Role lead

Responsible Party

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Paul J. Juliano, M.D.

Professor of Orthopaedic Surgery

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Paul J Juliano, M.D.

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Locations

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Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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IRB - 39025

Identifier Type: -

Identifier Source: org_study_id

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