Effects of Lacosamide on Post-operative Opioid Requirements After a Total Hip Arthroplasty:
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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Recruitment Status : Withdrawn (We were unable to enroll any patients into the study.)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
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis Rheumatoid Arthritis Avascular Necrosis||Drug: Placebo Drug: Lacosamide||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
Placebo Comparator: Placebo
Patient will randomly receive a placebo
Patients will randomly receive placebo
Patients will randomly receive experimental drug (lacosamide).
Patients will randomly receive lacosamide
- Opioid use in Post anesthesia care unit [ Time Frame: 30 minutes to 2 hours after surgery ]Post operative opioid use.
- Pain scores [ Time Frame: Post operative Day #0 through hospital discharge (4 day average) ]Post operative pain scores
- Nausea and Vomiting [ Time Frame: Post operative Day #0 through hospital discharge (4 day average) ]Post operative nausea and vomiting
- Total opioid use [ Time Frame: Post operative Day #0 through hospital discharge (4 day average) ]Total post operative opioid use
- Time to PACU discharge readiness [ Time Frame: 30 minutes to 2 hours after surgery ]Post operative discharge readiness
- Pain scores and opioid use at 3 month discharge [ Time Frame: At 3 month surgery follow up ]Development of chronic pain
- Time to hospital discharge [ Time Frame: Post operative Day #0 through hospital discharge ( 4 day average ) ]Hospital discharge
- 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 )
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
|United States, Indiana|
|Richard L. Roudebush Veterans Affairs Medical Center|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Bryan M Sakamoto, M.D., PhD||Richard L. Roudebush VA Medical Center|