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Risk of Falling After CFNB Versus ACB

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ClinicalTrials.gov Identifier: NCT02314832
Recruitment Status : Completed
First Posted : December 11, 2014
Last Update Posted : March 30, 2017
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
Blocking sensation from the femoral nerve by injecting local anesthetic around the nerve plays an important role in pain control after total knee replacement. However, femoral nerve block has been associated with increased risk of falls due to weakness of the thigh muscle. This prospective, randomized controlled trial asks the question whether blocking the more distal branch of the femoral nerve (saphenous nerve) will result in less muscle motor block, and thus less risk of falls. The study also aims to compare pain control after both techniques.

Condition or disease Intervention/treatment Phase
Falls Total Knee Arthroplasty (TKA) Osteoarthritis Procedure: adductor canal block Procedure: femoral nerve block Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison Between the Risk Falls After Total Knee Arthroplasty With Use of Femoral Nerve Block Versus Adductor Canal Block
Study Start Date : September 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Continuous femoral nerve block
patients receiving continuous femoral nerve block for analgesia after total knee arthroplasty
Procedure: femoral nerve block
ultrasound guided femoral nerve block

Active Comparator: adductor canal block
adductor canal block group will receive adductor canal block for analgesia after TKA
Procedure: adductor canal block
ultrasound guided saphenous nerve block in the adductor canal




Primary Outcome Measures :
  1. risk of falling score [ Time Frame: 24 hours after surgery ]

    The percentage of patients at high risk of falls as evaluated by Tinetti score in both groups.

    Scores of 19 or less are usually associated with higher risk of falls.



Secondary Outcome Measures :
  1. Pain scores [ Time Frame: 48 hours ]
    pain scores at rest and with movement



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for primary total knee arthroplasty
  • American Society of Anesthesiologists (ASA) physical status I -III
  • mentally competent and able to give consent for enrollment in the study

Exclusion Criteria:

  1. Patient younger than 18 years old
  2. Allergy to local anesthetics, systemic opioids (fentanyl, morphine, hydromorphone, and any of the drugs included in the multimodal perioperative pain protocol (MP3).
  3. Revision surgery will be excluded.
  4. Impaired kidney functions and patient with coagulopathy will also be excluded.
  5. Chronic pain syndromes; Patients will be defined to have chronic pain if they are using regular daily doses of systemic narcotics for the past 3 months prior to the surgery.
  6. BMI of 40 or more
  7. Pregnancy (positive urine pregnancy test result in Preop area on morning of surgery)

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): NCT02314832


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Nabil M Elkassabany, MD University of Pennsylvania

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02314832     History of Changes
Other Study ID Numbers: 820115
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017

Keywords provided by University of Pennsylvania:
femoral nerve block
adductor canal block
tinetti score
2- Results to time to up and go (TUG ) test
3- Results to Tinetti test
4- Ambulation distance
5- Pain scores at rest and with movement

Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases