Effects of Lacosamide on Post-operative Opioid Requirements After a Total Hip Arthroplasty:



Status:Recruiting
Conditions:Arthritis, Arthritis, Osteoarthritis (OA), Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 70
Updated:4/21/2016
Start Date:November 2014
End Date:May 2017
Contact:Bryan M Sakamoto, M.D., PhD
Email:bryan.sakamoto@va.gov
Phone:988-4699

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Effects of Lacosamide on Post-operative Opioid Requirements After a Total Hip Arthroplasty: A Randomized Double -Blinded, Placebo-controlled Pilot Study.

The purpose of this study is to determine how effect lacosamide is in reducing the amount of
pain medication needed following a total hip arthroplasty. The study team hypothesizes that
a single dose of lacosamide will reduce the amount of pain medication required after
surgery. The study team plans to evaluate the amount of pain medication needed and quality
of pain control during a subject's hospital stay and at their three month follow-up visit
following their surgery.

All patients who agree to participate in this study will receive the same surgical and
anesthetic techniques that are provided to all our patients undergoing this procedure at
this institution. Post-operative treatment and therapy and follow-up will also be the same
as any of our patients undergoing this procedure at this institution.

The only difference would be that patients would be randomized (determined by chance, like a
flip of a coin) to either receive a single dose of lacosamide (100 mg by mouth) or placebo
(sugar pill by mouth) before the surgical procedure. This would be the only experimental
part of this study.

In addition, specific information will be collected throughout the patients care until
discharged from the orthopedic clinic (approximately 3 months after the procedure). The
collected information will include subject's age, race and ethnicity, sex, height, weight,
American Society of Anesthesiologist physical status, total amount of opioid (pain
medication) use, pain scores, nausea and vomiting, time spent in the post anesthesia care
unit (time to discharge readiness), and discharge from the hospital. The patient's pain
score and opioid use will be assessed during their follow-up at approximately 3 months
(Note: all of the specific information collected is normally gathered or documented in our
surgical patients' record). In addition, participants may withdraw from the study at any
time.

The main goal of this study is to determine if lacosamide can reduce the amount of opioids
required in patient's undergoing a total hip arthroplasty. Lacosamide is a FDA approved
medication for the treatment of partial-onset seizures and is a man-made amino acid (usually
are used as the building blocks from which proteins are made in the body) which block
special proteins inby a change in the electricity that a cell may feel (voltage-gated sodium
channel). Lacosamide is a new antiepileptic drug apparently lacking any major
pharmacokinetic interactions (how the body affects a specific drug after administration, as
well as the chemical changes of the substance in the body, and the effects and routes of
excretion of the metabolites of the drug).

Lacosamide, carbamazepine and oxcarbazepine are known to block special proteins in the
covering of cells which allow sodium into the cells when they are turned on by a change in
the electricity that a cell may feel (voltage-gated sodium channel, NaV1.7). Lacosamide was
chosen over carbamazepine and oxcarbazepine because it causes fewer side effects. Currently,
lacosamide is being tested in patients with painful diabetic nerve pain. Further trials to
identify lacosamide's potential in pain control and for other indications have been started.

Inclusion Criteria:

- Patients will be eligible for participation if they are 18-70 years of age.

- Patients who have an American Society of Anesthesiologists physical status I-III.

- Patients who are scheduled for primary total hip arthroplasty.

- Any patients who are willing to comply with study requirements and agrees to be in
the study.

Exclusion Criteria:

- A patient's refusal to participate.

- Inability to give consent.

- Any patients on a scheduled opioid regimen for pain greater than 3 months.

- Bleeding diathesis.

- Hypersensitivity to lacosamide or any component of the formulation (some formulation
contains phenylalanine) and/or any drug allergies to any medications used in this
study.

- Second- or third-degree atrioventricular (AV) block, sick sinus syndrome without
pacemaker, sodium channelopathies (e.g., Brugada syndrome), myocardial ischemia,
heart failure, and structural heart disease.

- Severe hepatic and or renal impairment.

- Pregnant or can become pregnant.

- Breast-Feeding.

- Have any suicidal thoughts, depression, or behavioral changes.

- Taking any antiepileptic medications.

- Any known seizure disorder (e.g. Lennox-Gastaut syndrome).

- Currently prescribed:

Carbamazepine Strong inhibitors of cytochrome P450-2C9 (Capecitabine; Delavirdine;
floxuridine; Fluorouracil (Systemic); Gemfibrozil; Nicardipine; Sitaxentan; Sulfadiazine;
Sulfissoxazole; Tegafur; Tolbutamide) Strong inhibitors of cytochrome P450-3A4
(Atazanavir; Boceprevir; Chloramphenicol; Clarithromycin; Cobicistat; Conivaptan;
Darunavir; Delavirdine; Fosamprenavir; Indinavir; Itraconazole; Ketoconazole (Systemic);
Lopinavir; Nefazodone; Nelfinavir; Nicardipine; Posaconazole; Ritonavir; Saquinavir;
Telaprevir; Telithromycin; Voriconazole) Delavirdine Fosphenytoin Nicardipin Phenobarbital
Phenytoin Ethinylestradiol
We found this trial at
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Indianapolis, Indiana 46202
Phone: 317-988-4699
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