Effects of Femoral vs Saphenous Nerve Blocks on Function After ACL Repair

NCT ID: NCT01919658

Last Updated: 2019-06-21

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

TERMINATED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2019-06-10

Brief Summary

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The primary objective of the study is to compare motor strength in knee extension between two groups of patients. One group receiving a proximal thigh block of the femoral nerve, and one receiving a distal thigh block of the saphenous nerve. The secondary objective is to compare the pain relief and functional outcomes in these two groups.

Detailed Description

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Conditions

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Anterior Cruciate Ligament

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 nerve block

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

Group Type ACTIVE_COMPARATOR

nerve block

Intervention Type PROCEDURE

A nerve block performed as per standard of care: femoral nerve blocks, and saphenous nerve blocks performed more distally (within 10cm superior to the adductor tubercle).

distal nerve block

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

Group Type ACTIVE_COMPARATOR

nerve block

Intervention Type PROCEDURE

A nerve block performed as per standard of care: femoral nerve blocks, and saphenous nerve blocks performed more distally (within 10cm superior to the adductor tubercle).

Interventions

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nerve block

A nerve block performed as per standard of care: femoral nerve blocks, and saphenous nerve blocks performed more distally (within 10cm superior to the adductor tubercle).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Age 18-65
2. Upcoming ACL reconstruction using patellar tendon autograft scheduled at Hershey Medical Center or the Hershey Outpatient Surgical Center (HOSC)

Exclusion Criteria

1. Documented neuropathy
2. Skeletally immature
3. Previous knee surgery
4. Inability to provide informed consent
5. ACL reconstruction with other tendon repairs
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Robert A. Gallo

OTHER

Sponsor Role lead

Responsible Party

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Robert A. Gallo

Assistant Professor of Orthopaedic Surgery Sports Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Robert Gallo, MD

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Locations

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Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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IRB 42734

Identifier Type: -

Identifier Source: org_study_id

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