Analgesia in Total Knee Arthroplasty Clinical Trial
Official title:
A Prospective, Randomized Study Comparing Continuous Femoral and Tibial Nerve Blocks vs. Continuous Femoral and Single Shot Sciatic Nerve Block in Total Knee Arthroplasties.
The purpose of this study is to evaluate whether a new regional anesthesia technique would provide better pain control, patient satisfaction, less narcotic use and no symptoms of foot drop after knee replacement surgery.
The aim of this study is to compare and measure the effects of Ropivicaine given through
catheters located in the femoral and tibial nerves on indices of sensory blockade after total
knee arthroplasties. This is a randomized, prospective study designed to address the primary
research question: Does placing a continuous femoral & tibial catheter infusion lead to
superior analgesia and patient satisfaction during the entire hospital stay? The secondary
research question is: Will selectively placing a continuous tibial catheter decrease the
episodes of transient foot drop to zero? Investigators know from own regional institutional
practices that by performing a continuous femoral with a single shot sciatic nerve block
provides adequate analgesia of the entire leg, but by post-operative day 2 patient's begin to
experience pain with rehabilitation and rest in the posterior-lateral aspect of the knee and
leg secondary to wearing off of the sciatic nerve block anesthetic. Also, it is known that by
blocking the sciatic nerve proximal to its bifurcation may lead to episodes of transient foot
drop due to common peroneal nerve blockage and irritation. It is hypothesized that placement
of continuous catheters in the femoral and tibial nerves would provide better analgesia and
lead to no episodes of foot drop as compared to the patients that receive continuous femoral
and single shot sciatic blocks.
Currently at Texas Tech Health Science Center-El Paso and University Medical Center, about
95% of patient's undergoing total knee arthroplasty's (TKAs) receives a continuous femoral
infusion and a single shot sciatic with an initial bolus of 30mL (femoral) and 20mL (sciatic)
of Ropivicaine 0.5% and an infusion of Ropivicaine 0.2% at a rate of 10cc/hr (usually started
post-op) for at least the first 48-72 hours post-operatively. For our study, Orthopedic
clinic will provide a copy of the consent form to the subject so that they can review it, and
if interested in participating in the study, the patient can then contact the Principal
Investigator or Study Coordinator directly. After informed consent is obtained, patients will
be randomized during that time using a numbering system enclosed in sealed envelopes. Group 1
will receive a pre-operative continuous femoral catheter and a post-operative single shot
sciatic with both given an initial bolus of 30 mL (femoral) 0.5% Ropivicaine and 20mL
(sciatic) 0.2% Ropivicaine. Following surgery the femoral infusion will be started, which
will be running Ropivicaine 0.2 at 10cc/hr. Group 2 will receive a pre-operative continuous
femoral catheter and a post-operative continuous tibial catheter with an initial bolus of 30
mL 0.5% Ropivicaine (femoral) and 20mL 0.2% Ropivicaine (tibial), which will be followed by
infusions post-operatively running at the same rate and dosage as group 1. All nerve blocks
performed will be placed using a nerve stimulator (with no twitches lower than 0.2mA) under
ultrasound-guidance. Proper catheter placement will be confirmed by injecting 3mL of air and
visualizing by ultrasound. Once confirmed, the bolus dose as mentioned earlier of either
Ropivicaine 0.5% (femoral) or 0.2% (sciatic/tibial) will be injected. All TKA cases will be
performed under general anesthesia with laryngeal mask airway. Considering the fact that by
placing a selective continuous tibial catheter pre-operatively, we run the risk of the
catheter being the surgical field during the case. For this reason, it was decided that
placement after the procedure would be best. Therefore, the patient will be taken back to the
block room post-operatively and a continuous tibial nerve catheter or single shot (depending
on what group assigned) will be placed and bolused using the same technique as previously
described. To detect a 30% reduction in the pain score from 3-4 to a 1-2 would be required
for an observed post-operative pain control difference. In order to achieve a statistically
significant result to detect the previously observed difference, a sample of 38 patients in
each group (total of 76) would be required. Assuming a high consent rate and given the fact
many TKA's it is projected that this study can be completed in approximately 12 months.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02104934 -
A Randomised Controlled Trial Comparing Single Shot Adductor Canal Block With Local Infiltration Analgesia for Postoperative Analgesia After Total Knee Arthroplasty
|
N/A |