Study Stopped
Difficulty enrolling, aim already examined in literature.
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
1 other identifier
interventional
12
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 6, 2013
CompletedFirst Posted
Study publicly available on registry
August 9, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2019
CompletedJune 21, 2019
June 1, 2019
5.9 years
August 6, 2013
June 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
pain level and functional outcomes
change from in hospital post-operative period at 12 months
Study Arms (2)
proximal nerve block
ACTIVE COMPARATORThe anesthesiologist will administer a proximal nerve block if specified in the randomization envelope.
distal nerve block
ACTIVE COMPARATORThe anesthesiologist will administer a distal nerve block if specified in the randomization envelope.
Interventions
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).
Eligibility Criteria
You may qualify if:
- Age 18-65
- Upcoming ACL reconstruction using patellar tendon autograft scheduled at Hershey Medical Center or the Hershey Outpatient Surgical Center (HOSC)
You may not qualify if:
- Documented neuropathy
- Skeletally immature
- Previous knee surgery
- Inability to provide informed consent
- ACL reconstruction with other tendon repairs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Robert A. Gallolead
Study Sites (1)
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Gallo, MD
Milton S. Hershey Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor of Orthopaedic Surgery Sports Medicine
Study Record Dates
First Submitted
August 6, 2013
First Posted
August 9, 2013
Study Start
July 1, 2013
Primary Completion
June 10, 2019
Study Completion
June 10, 2019
Last Updated
June 21, 2019
Record last verified: 2019-06