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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01919658
Other study ID # IRB 42734
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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