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

Effects of Femoral Versus Saphenous Nerve Blocks on Knee Extensor Strength, Pain, and Patient-Perceived Physical Function Following ACL Reconstruction

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.

Study Overview

• Status: Terminated
• Conditions: Anterior Cruciate Ligament
• Intervention / Treatment: Procedure: nerve block

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State 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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: proximal nerve block; The anesthesiologist will administer a proximal nerve block if specified in the randomization envelope.	Procedure: 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).
ACTIVE_COMPARATOR: distal nerve block; The anesthesiologist will administer a distal nerve block if specified in the randomization envelope.	Procedure: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
strength of knee extensors	Extensor testing will be conducted in both legs using a hand held dynamometer.	change from baseline preoperatively at 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain level and functional outcomes	Medical record will be reviewed for type and amount of in hospital post operative medication and levels, then assessed by PROMIS survey at follow up appointments.	change from in hospital post-operative period at 12 months

Collaborators and Investigators

• Sponsor: Robert A. Gallo
• Investigators: Principal Investigator: Robert Gallo, MD, Milton S. Hershey Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2013
• Primary Completion (ACTUAL): June 10, 2019
• Study Completion (ACTUAL): June 10, 2019

Study Registration Dates

• First Submitted: August 6, 2013
• First Submitted That Met QC Criteria: August 7, 2013
• First Posted (ESTIMATE): August 9, 2013

Study Record Updates

• Last Update Posted (ACTUAL): June 21, 2019
• Last Update Submitted That Met QC Criteria: June 19, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: nerve blocks in Anterior cruciate ligament surgery
• Other Study ID Numbers: IRB 42734