Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to compare a single shot block, 24 hours, and 48 hour continuous catheter nerve block done via the adductor canal method in adult patients who have under gone total knee arthroplasty. Visual analogue scores, opioid consumption, time to up and go, ambulation, manual muscle tests, and Tinetti scores up to 72 hours post operatively will be used for comparison.


Clinical Trial Description

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

1. Single shot block

2. 24 hour catheter

3. 48 hour catheter

The choice of anesthetic technique will be at the discretion of the anesthesiologist. In our institution we usually advocate for spinal anesthesia for total knee arthroplasty. All patients will receive their multimodal perioperative pain protocol (MP3) medication as per protocol in the patient receiving area (400 mg of gabapentin, 200 mg of Celecoxib, and 1gm of acetaminophen).

Patients will be monitored during block performance with standard ASA monitors. All patients will be receiving 2 L of oxygen via a nasal cannula. Sedatives will be titrated to effect. Midazolam 1-2 mg, and fentanyl 50-100 mcg will be used for sedation.

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 single shot and continuous adductor canal block will be performed according to the standard operating practices in our department 4. 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 local anesthesia bolus will be used to verify correct placement of the needle in the vicinity of the saphenous nerve in the adductor canal.

For single shot blocks: A bolus of total volume of 20 ml of ropivicaine 0.5% will be injected through the needle.

For the continuous block: The catheter will be introduced and advanced 2-3 cm beyond the tip of the needle under ultrasound visualization. The needle was withdrawn over the catheter. Injection of a bolus of 5 ml of ropivacaine 0.5% will take place through the catheter while observing the spread of local anesthetic under ultrasound. The catheter hub will be affixed to the upper lateral thigh with sterile occlusive dressings and an anchoring device.

Block success will be defined as a change in cutaneous sensation to touch with an alcohol pad in the saphenous nerve distribution over the medial leg within 30min after injection. Subjects with successful catheter placement per protocol and nerve block onset were retained in the study. Subjects with a failed catheter insertion or misplaced catheter indicated by a lack of sensory changes had their catheter replaced or were withdrawn from the study.

At the conclusion of surgery, the catheters will be connected to a pump that will infuse local anesthetic. Ropivicaine 0.2% at 8 ml/hour. In the postoperative anesthesia care unit, intermittent boluses of hydromorphone will be used as needed. Postoperative analgesia will follow the MP3 protocol. Drugs that are used for the multimodal analgesia protocol include acetaminophen (1 gm every 8 hours for 72 hours), celecoxib (200 mg every 8 hours for 72 hours), Gabapentin (300 mg every 8 hours for one week if the patient is opioid naïve and for two weeks if patients are opioid tolerant), and oxycodone (5-10-15 mg oral as needed every 4 hours for pain based on patient reported pain score).

All patients will receive prophylaxis for postoperative nausea and vomiting (PONV) during surgery. The protocol for prophylaxis against PONV include administration of 4 mg of dexamethasone after induction of anesthesia and 4 mg of ondansetron 20 minutes before recovery from anesthesia. Dexamethasone is withheld if the patient has poorly controlled diabetes mellitus (DM). Uncontrolled DM will be defined as random blood glucose above 250 mg/dl. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02730728
Study type Interventional
Source University of Pennsylvania
Contact
Status Completed
Phase N/A
Start date November 1, 2015
Completion date January 1, 2017

See also
  Status Clinical Trial Phase
Completed NCT04657926 - A Trial of APPA in the Treatment of Knee Osteoarthritis Phase 2
Completed NCT02536833 - A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects Phase 2
Completed NCT03014037 - Comparing Mesenchymal Stem Cell Counts in Unilateral vs. Bilateral Posterior Superior Iliac Spine Bone Marrow Aspiration N/A
Recruiting NCT05937542 - A Qualitative Investigation of CLEAT Participants
Completed NCT03644615 - A Mindfulness Program (MBSR) in the Management of Symptomatic Hip and Knee Osteoarthritis N/A
Recruiting NCT06061367 - Muscles Strength and Gait Parameteres After TKA
Withdrawn NCT04976972 - A Comparison of Patients Receiving a Total Knee Replacement With Robotic Assistance or With Conventional Instrumentation N/A
Completed NCT05496205 - A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers Phase 1
Completed NCT03850665 - Comparison of Functional Outcome in Patients After Hip Arthroplasty Depending on Surgical Approach N/A
Completed NCT02826902 - Effect of Anesthesia on Quality of Recovery in Patients Undergoing Correctional Tibial Osteotomy - A Randomized Controlled Trial N/A
Completed NCT04402502 - Dynamic 4DCT to Examine Wrist Carpal Mechanics N/A
Completed NCT02923700 - Leukocyte-rich PRP vs Leukocyte-poor PRP for the Treatment of Knee Cartilage Degeneration: a Randomized Controlled Trial Phase 4
Completed NCT04564053 - Study of Safety, Tolerability and Pharmacokinetics of LNA043 in Japanese Osteoarthritis Participants Phase 1
Completed NCT05070871 - A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women N/A
Not yet recruiting NCT05036174 - Diphenhydramine Ointment for Knee Osteoarthritis N/A
Recruiting NCT02666443 - Low Dose Dexamethasone in Supraclavicular Blocks N/A
Recruiting NCT02912429 - Onlay vs. Inlay Patellofemoral Arthroplasty N/A
Active, not recruiting NCT02723929 - Effects of tDCS and tUS on Pain Perception in OA of the Knee
Withdrawn NCT02921594 - Kinematic Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties N/A
Terminated NCT02820766 - Journey II BCS CMS Total Knee System Compared to Other PS Total Knee Systems in PT Setting N/A