Overview

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

Status:
Withdrawn
Trial end date:
2016-08-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Indiana University School of Medicine
Collaborator:
VA Office of Research and Development
Treatments:
Lacosamide
Criteria
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