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CompletedNCT02314832Updated Mar 30, 2017

Risk of Falling After CFNB Versus ACB

An interventional study of adductor canal block and femoral nerve block in Falls, Total Knee Arthroplasty (TKA) and Osteoarthritis, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-03-30.

Sponsored by University of Pennsylvania · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description

If the patient is willing to participate and signs the consent, he/she will be randomized to one of the two treatment groups:

  1. Femoral nerve block
  2. Adductor canal block

The standard of care anesthesia regimen for this surgery is as follows:

All Patients will receive their Multimodal Perioperative Pain Protocol (MP3) medication as per routine care in the patient receiving area. All blocks are performed in the pre-operative holding area with standard ASA monitors applied. Typically, patients receive 1-2 mg of midazolam and 50-100 mcg of fentanyl for sedation during the placement of the block. Standard operating procedure of the block room will be followed. Block time out will be preformed according to standard operating procedure. All blocks will be done under ultrasound guidance. Sonosite (S nerve) machine will be used with a high frequency linear (HFL) US probe with 6-13 MHZ frequency. Both CFNB and ACB will take be performed according to the SOP in the investigators department.

For CFNB: Images of the femoral nerve will be obtained in the short axis. 1% lidocaine will be used for local infiltration of the skin. A 2 inch 18 G touhy needle ( B Braun) will be advanced in plane under US guidance . Confirmation may take place with Quadricpes muscle twitches and patella movement between 0.3 and 0.4mA (2Hz; 0.1ms). A bolus of 20 ml of Ropivicaine 0.5% will be injected. A non stimulating catheter will be advanced through the needle to a distance of 3-4 cm beyond the needle tip. Catheter will be secured in place using benzoin, Steristrips, and a tegaderm.

For the ACB: ultrasound survey at the medial part of the thigh will take place, halfway between the superior anterior iliac spine and the patella. In a short axis view, the femoral artery will be identified underneath the sartorius muscle, with the vein just inferior and the saphenous nerve just lateral to the artery. The needle will be introduced in-plane and 2 to 3 mL of LA bolus (0.2% ropivicaine) will be used to verify correct placement of the needle in the vicinity of the saphenous nerve in the adductor canal. A bolus of total volume of 20 ml of Ropivicaine 0.5% will be injected through the needle. The catheter will then be introduced and advanced 2-3 cm beyond the tip of the needle.

At the conclusion of surgery a large obaque dressing will be applied from the femoral crease to the mid thigh region so that the catheter location will be concealed. Both catheters will be connected to a pump that will infuse local anesthetic. Ropivicaine 0.2% at 8 ml/hour. There is usually a period of time before the patient transport to the operating room during which the investigators will be able to evaluate if the block is effective and sufficient for surgery.

Patients will receive either general or spinal anesthesia in the operating room. All patients will receive prophylaxis for nausea and vomiting during surgery. Regimen for prophylaxis include a single dose of dexamethasone after induction of anesthesia and a single dose of Ondansetron 20 minutes before recovery from anesthesia. This study is not deviating from the standard of care anesthetic regimen for this surgical procedure at Penn Presbyterian Medical Center. Only the type of blocks will be different between the two groups.

Postoperative analgesia All PACU analgesia will follow standard of care protocol for post operative care at PPMC. Hydromorphone 0.2 mg iv q5 minutes as necessary. The infusion of the local anesthetic will start in the PACU.

In the PACU, patients are assessed for pain with the Visual Analog Scale (pain scale of 1 to 10) at routine time points for the duration of their stay. The worse VAS score will be recorded.

Postoperative Analgesia

Postoperative analgesia will follow the MP3 protocol. The protocol includes administration of around the clock acetaminophen, Celebrex, gabapentin, immediate and extended release oxycodone.

02

Conditions studied

  • Falls
  • Total Knee Arthroplasty (TKA)
  • Osteoarthritis

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Keywords

  • 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
03

In context

Osteoarthritis

4,445 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 62 is below the median of 70 across 3,474 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,664 studies on the registry; 236 are open to participants now.

Of its 156 completed or terminated interventional studies of FDA-regulated products, 107 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
62 participants (actual)

Study arms

  • Active comparator
    Continuous femoral nerve block

    patients receiving continuous femoral nerve block for analgesia after total knee arthroplasty

    Procedure: 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

Interventions

  • Procedureadductor canal block

    ultrasound guided saphenous nerve block in the adductor canal

  • Procedurefemoral nerve block

    ultrasound guided femoral nerve block

06

What researchers measure

Primary outcomes

  1. risk of falling score

    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.

    Time frame: 24 hours after surgery

Secondary outcomes

  1. Pain scores

    pain scores at rest and with movement

    Time frame: 48 hours

07

Study locations

1 site
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02314832
Responsible party
Sponsor
First posted
Dec 11, 2014
Start date
Sep 2014
Primary completion
Jan 2015
Completion
Mar 2015
Last update
Mar 30, 2017

Study contacts

Nabil M Elkassabany, MD
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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