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

NCT02342977 | Withdrawn Phase 2 DMC

• 1 other identifier: 1408905316
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis; Rheumatoid Arthritis; Avascular Necrosis

Keywords

total hip arthroplasty

Outcome Measures

Primary Outcomes (1)

• Opioid use in Post anesthesia care unit

  Post operative opioid use.

  30 minutes to 2 hours after surgery

Secondary Outcomes (7)

• Pain scores

  Post operative Day #0 through hospital discharge (4 day average)

• Nausea and Vomiting

  Post operative Day #0 through hospital discharge (4 day average)

• Total opioid use

  Post operative Day #0 through hospital discharge (4 day average)

• Time to PACU discharge readiness

  30 minutes to 2 hours after surgery

• Pain scores and opioid use at 3 month discharge

  At 3 month surgery follow up

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Patient will randomly receive a placebo

Drug: Placebo

Experimental

EXPERIMENTAL

Patients will randomly receive experimental drug (lacosamide).

Drug: Lacosamide

Interventions

Placebo DRUG

Patients will randomly receive placebo

Placebo

Lacosamide DRUG

Patients will randomly receive lacosamide

Experimental

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University School of Medicine: lead
• VA Office of Research and Development: collaborator

Study Sites (1)

Richard L. Roudebush Veterans Affairs Medical Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Arthritis, Rheumatoid; Osteonecrosis

Interventions

Lacosamide

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids

Study Officials

• Bryan M Sakamoto, M.D., PhD

  Richard L. Roudebush VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Effects of lacosamide on post-operative opioid requirements after a total hip arthroplasty: A randomized double -blinded, placebo-controlled pilot study.

Study Record Dates

• First Submitted: December 18, 2014
• First Posted: January 21, 2015
• Study Start: November 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 26, 2016

Record last verified: 2016-08

Locations

US (1)