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NCT02840240 · ClinicalTrials.gov registry record · NA
Effect of Gabapentin Enacarbil on Opioid Consumption and Pain Scores
A NA study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- NA
- Development phase
- 107
- Enrollment target
NCT02840240 is a NA study that has completed, run by The Cleveland Clinic. The registered enrollment target is 107 participants.
The verdict
NCT02840240, a NA study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 107 participants
- Enrollment target
Study Summary
Opioids are effective analgesics, but cause side effects including sedation, respiratory depression, low blood pressure, nausea, and constipation. Gabapentin enacarbil, which is a FDA approved drug for post herpetic neuralgia (nerve pain related to shingles) and restless leg syndrome, may decrease your need for narcotics and thus decrease the risk of side effects. The investigator hopes this study will determine if gabapentin enacarbil decreases opioid consumption and pain after surgery. Patients having elective hip and knee surgery will be asked to participate in the study. Patients will be randomized to Gabapentin enacarbil 600mg twice per day for 5 days or Placebo twice per day for 5 days. One day prior to surgery the patient will take Gabapentin enacarbil 600mg or placebo 600mg twice a day with meals. On the day of surgery, the patient will take Gabapentin enacarbil 600mg or placebo 600mg two hours before the surgical procedure. Six hours after the completion of surgery, the patient will receive Gabapentin enacarbil 600mg or placebo 600mg. If the patient is sent home, the patient will be given 6 Gabapentin enacarbil 600mg or placebo 600mg pills to take home along with instructions. However, if the patient remains hospitalized, on the first day after the surgery, the patient will have pain assessed in the morning using a numerical rating score. The patient's quality of recovery will be evaluated using a questionnaire and the patient will receive Gabapentin enacarbil 600mg or placebo 600mg twice a day with meals. The second and third day the patient is in the hospital, the patient will have pain assessed in the morning using a numerical rating score and the patient will receive Gabapentin enacarbil 600mg or placebo 600mg twice a day with meals. Then, three months after surgery, the patient will receive a phone call to follow-up with possible pain or discomfort the patient may be feeling.
Interventions
- DRUG Placebo
- DRUG Gabapentin enacarbil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2016-01 |
| Est. Completion | 2021-04-23 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02840240
The ClinicalTrials.gov registry entry for NCT02840240 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 107 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02840240 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02840240 about?
NCT02840240 is a clinical study titled "Effect of Gabapentin Enacarbil on Opioid Consumption and Pain Scores". Opioids are effective analgesics, but cause side effects including sedation, respiratory depression, low blood pressure, nausea, and constipation. Gabapentin enacarbil, which is a FDA approved drug for post herpetic neuralgia (nerve pain related to shingles) and restless leg syndrome, may decrease y...
What is the current status of trial NCT02840240?
This trial is currently completed. It is a NA study. The enrollment target is 107 participants. The study started on 2016-01. Estimated completion is 2021-04-23.
What interventions are being tested in trial NCT02840240?
The interventions under investigation include: Placebo (DRUG), Gabapentin enacarbil (DRUG).
Who is sponsoring clinical trial NCT02840240?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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