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

Anterior Cruciate Ligament Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01919658
• Other study ID #: IRB 42734
• Status: Terminated
• Phase: N/A
• Start date: July 2013
• Est. completion date: June 10, 2019

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: June 10, 2019
• Est. primary completion date: June 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament

Intervention

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).

Locations

Country	Name	City	State
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Robert A. Gallo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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