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

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ClinicalTrials.gov Identifier: NCT01919658
Recruitment Status : Terminated (Difficulty enrolling, aim already examined in literature.)
First Posted : August 9, 2013
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Robert A. Gallo, Milton S. Hershey Medical Center

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.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Procedure: nerve block Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Femoral Versus Saphenous Nerve Blocks on Knee Extensor Strength, Pain, and Patient-Perceived Physical Function Following ACL Reconstruction
Actual Study Start Date : July 2013
Actual Primary Completion Date : June 10, 2019
Actual Study Completion Date : June 10, 2019

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).




Primary Outcome Measures :
  1. strength of knee extensors [ Time Frame: change from baseline preoperatively at 12 months ]
    Extensor testing will be conducted in both legs using a hand held dynamometer.


Secondary Outcome Measures :
  1. pain level and functional outcomes [ Time Frame: change from in hospital post-operative period at 12 months ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01919658


Locations
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United States, Pennsylvania
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Robert A. Gallo
Investigators
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Principal Investigator: Robert Gallo, MD Milton S. Hershey Medical Center
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Responsible Party: Robert A. Gallo, Assistant Professor of Orthopaedic Surgery Sports Medicine, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01919658    
Other Study ID Numbers: IRB 42734
First Posted: August 9, 2013    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Keywords provided by Robert A. Gallo, Milton S. Hershey Medical Center:
nerve blocks in Anterior cruciate ligament surgery