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

Rheumatoid Arthritis Clinical Trial

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

Status Withdrawn

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Avascular Necrosis
• Necrosis
• Osteoarthritis
• Rheumatoid Arthritis

• NCT number: NCT02342977
• Study type: Interventional
• Source: Indiana University
• Status: Withdrawn
• Phase: Phase 2
• Start date: November 2014
• Completion date: August 2016