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
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.
If the patient is willing to participate and signs the consent, he/she will be randomized to one of the two treatment groups:
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.
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 →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.
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.
Exclusion Criteria:
patients receiving continuous femoral nerve block for analgesia after total knee arthroplasty
Procedure: femoral nerve 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
ultrasound guided femoral nerve block
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
Pain scores
pain scores at rest and with movement
Time frame: 48 hours
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.