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Effect of Gabapentin Enacarbil on Opioid Consumption and Pain Scores

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: NCT02840240
Recruitment Status : Active, not recruiting
First Posted : July 21, 2016
Last Update Posted : August 20, 2020
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

Brief 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.


Condition or disease Intervention/treatment Phase
Pain Drug: Gabapentin enacarbil Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: Placebo
600 mg BID taken 1 day pre-op and 2 hours before surgery, 6 hours after surgery, 600 mg 3 days post-operative




Primary Outcome Measures :
  1. 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

  2. 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 .



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men or women 18-85 years of age.
  2. Scheduled for elective knee or hip arthroplasty with spinal anesthesia.

Exclusion Criteria:

  1. Creatinine >1.50 mg/dl.
  2. History of clinically important current depression or currently on any prescribed anti-depressant medication.
  3. Previously enrolled in any Xenoport trial.
  4. Use of gabapentin or gabapentinoids (Lyrica, Horizant, Neurontin or Gralise) within one month.
  5. Allergy to gabapentin or gabapentinoids (Lyrica, Horizant, Neurontin or Gralise).
  6. Women who are pregnant or breastfeeding.
  7. History of seizure disorder within the last one-year or taking medications for seizures.

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): NCT02840240


Locations
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United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Study Chair: Daniel Sessler, M.D. The Cleveland Clinic
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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02840240    
Other Study ID Numbers: 15-479
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: August 20, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents