Effect of Gabapentin Enacarbil on Opioid Consumption and Pain Scores
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|ClinicalTrials.gov Identifier: NCT02840240|
Recruitment Status : Completed
First Posted : July 21, 2016
Last Update Posted : September 10, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Gabapentin enacarbil Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Controlled Trial to Determine the Effect of Gabapentin Enacarbil on Opioid Consumption and Pain Scores in Patients Having Hip and Knee Arthroplasties With Spinal Anesthesia|
|Actual Study Start Date :||January 2016|
|Actual Primary Completion Date :||November 30, 2018|
|Actual Study Completion Date :||April 23, 2021|
Experimental: Gabapentin enacarbil
Patients going through elective hip or knee replacement surgery with spinal anesthesia will receive Gabapentin enacarbil for 5 days
Drug: Gabapentin enacarbil
600 mg BID 1 day pre-op and 2 hours before surgery, 6 hours after surgery, 600 mg BID 3 days post-operative
Other Name: Xenoport
Placebo Comparator: Placebo
Patients going through elective hip or knee replacement surgery with spinal anesthesia will receive placebo for 5 days
600 mg BID taken 1 day pre-op and 2 hours before surgery, 6 hours after surgery, 600 mg 3 days post-operative
- Time weighted average pain score in numerical rating scores [ Time Frame: 72 hours after surgery or till discharge, whatever comes first ]Multiple pain measurements (numeric rating scale ranges from 0 to 10, where 0 - no pain and 10 - worse imaginable pain) over 72 hours after the surgery will be summarized by computing time weighted average pain score for each patient
- Cumulative postoperative opioid consumption [ Time Frame: 72 hours after surgery or till discharge, whatever comes first ]The total dose of opioid administered in the PACU and floor including the background analgesia (PCA) and boluses. All opioids will be converted into mg intravenous (IV) morphine equivalent to standardize opioid consumption .
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): NCT02840240
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Study Chair:||Daniel Sessler, M.D.||The Cleveland Clinic|