Risk of Falling After CFNB Versus ACB
Primary Purpose
Falls, Total Knee Arthroplasty (TKA), Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
adductor canal block
femoral nerve block
Sponsored by
About this trial
This is an interventional prevention trial for Falls focused on measuring 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
Eligibility 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:
- Patient younger than 18 years old
- Allergy to local anesthetics, systemic opioids (fentanyl, morphine, hydromorphone, and any of the drugs included in the multimodal perioperative pain protocol (MP3).
- Revision surgery will be excluded.
- Impaired kidney functions and patient with coagulopathy will also be excluded.
- 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.
- BMI of 40 or more
- Pregnancy (positive urine pregnancy test result in Preop area on morning of surgery)
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Continuous femoral nerve block
adductor canal block
Arm Description
patients receiving continuous femoral nerve block for analgesia after total knee arthroplasty
adductor canal block group will receive adductor canal block for analgesia after TKA
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Pain scores
pain scores at rest and with movement
Full Information
NCT ID
NCT02314832
First Posted
July 1, 2014
Last Updated
March 28, 2017
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT02314832
Brief Title
Risk of Falling After CFNB Versus ACB
Official Title
Comparison Between the Risk Falls After Total Knee Arthroplasty With Use of Femoral Nerve Block Versus Adductor Canal Block
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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:
Femoral nerve block
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Falls, Total Knee Arthroplasty (TKA), Osteoarthritis
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
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Continuous femoral nerve block
Arm Type
Active Comparator
Arm Description
patients receiving continuous femoral nerve block for analgesia after total knee arthroplasty
Arm Title
adductor canal block
Arm Type
Active Comparator
Arm Description
adductor canal block group will receive adductor canal block for analgesia after TKA
Intervention Type
Procedure
Intervention Name(s)
adductor canal block
Intervention Description
ultrasound guided saphenous nerve block in the adductor canal
Intervention Type
Procedure
Intervention Name(s)
femoral nerve block
Intervention Description
ultrasound guided femoral nerve block
Primary Outcome Measure Information:
Title
risk of falling score
Description
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 Outcome Measure Information:
Title
Pain scores
Description
pain scores at rest and with movement
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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:
Patient younger than 18 years old
Allergy to local anesthetics, systemic opioids (fentanyl, morphine, hydromorphone, and any of the drugs included in the multimodal perioperative pain protocol (MP3).
Revision surgery will be excluded.
Impaired kidney functions and patient with coagulopathy will also be excluded.
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.
BMI of 40 or more
Pregnancy (positive urine pregnancy test result in Preop area on morning of surgery)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nabil M Elkassabany, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
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Risk of Falling After CFNB Versus ACB
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