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

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ClinicalTrials.gov Identifier: NCT02342977
Recruitment Status : Withdrawn (We were unable to enroll any patients into the study.)
First Posted : January 21, 2015
Last Update Posted : August 26, 2016
Sponsor:
Collaborator:
VA Office of Research and Development
Information provided by (Responsible Party):
Bryan Sakamoto, VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Rheumatoid Arthritis Avascular Necrosis Drug: Placebo Drug: Lacosamide Phase 2

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Lacosamide on Post-operative Opioid Requirements After a Total Hip Arthroplasty: A Randomized Double -Blinded, Placebo-controlled Pilot Study.
Study Start Date : November 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Lacosamide

Arm Intervention/treatment
Placebo Comparator: Placebo
Patient will randomly receive a placebo
Drug: Placebo
Patients will randomly receive placebo

Experimental: Experimental
Patients will randomly receive experimental drug (lacosamide).
Drug: Lacosamide
Patients will randomly receive lacosamide




Primary Outcome Measures :
  1. Opioid use in Post anesthesia care unit [ Time Frame: 30 minutes to 2 hours after surgery ]
    Post operative opioid use.


Secondary Outcome Measures :
  1. Pain scores [ Time Frame: Post operative Day #0 through hospital discharge (4 day average) ]
    Post operative pain scores

  2. Nausea and Vomiting [ Time Frame: Post operative Day #0 through hospital discharge (4 day average) ]
    Post operative nausea and vomiting

  3. Total opioid use [ Time Frame: Post operative Day #0 through hospital discharge (4 day average) ]
    Total post operative opioid use

  4. Time to PACU discharge readiness [ Time Frame: 30 minutes to 2 hours after surgery ]
    Post operative discharge readiness

  5. Pain scores and opioid use at 3 month discharge [ Time Frame: At 3 month surgery follow up ]
    Development of chronic pain

  6. Time to hospital discharge [ Time Frame: Post operative Day #0 through hospital discharge ( 4 day average ) ]
    Hospital discharge

  7. Possible side effects from Lacosamide [ Time Frame: Post operative Day #0 through hospital discharge (4 day average) ]
    Possible side effects ( dizziness, headaches, visual changes, and nausea )



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02342977


Locations
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United States, Indiana
Richard L. Roudebush Veterans Affairs Medical Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
VA Office of Research and Development
Investigators
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Principal Investigator: Bryan M Sakamoto, M.D., PhD Richard L. Roudebush VA Medical Center

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Responsible Party: Bryan Sakamoto, Effects of lacosamide on post-operative opioid requirements after a total hip arthroplasty: A randomized double -blinded, placebo-controlled pilot study., VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02342977     History of Changes
Other Study ID Numbers: 1408905316
First Posted: January 21, 2015    Key Record Dates
Last Update Posted: August 26, 2016
Last Verified: August 2016

Keywords provided by Bryan Sakamoto, VA Office of Research and Development:
total hip arthroplasty

Additional relevant MeSH terms:
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Osteoarthritis
Arthritis, Rheumatoid
Necrosis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Lacosamide
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action