Effect of Gabapentin Enacarbil on Opioid Consumption and Pain Scores

NCT02840240 | Completed Results

• 1 other identifier: 15-479
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (2)

• Time Weighted Average Pain Score in Numerical Rating Scores

  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

  Initial 72 hours after surgery or until discharge, whatever comes first.

• Cumulative Postoperative Opioid Consumption

  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 .

  Initial 72 hours after surgery or until discharge, whatever comes first.

Secondary Outcomes (4)

• Number of Participants With Persistent Pain 90-day After Surgery

  within 90 days after surgery

• Postoperative Nausea and Vomiting (PONV) up to 72 Hours After Surgery

  Initial 72 hours after surgery

• Length of Hospital Stay in Hours

  From the end of surgery to discharge

• Quality of Recovery (QoR-15) Score 72 Hours After Surgery

  Initial 72 hours after surgery or shortly before hospital discharge.

Study Arms (2)

Gabapentin enacarbil

EXPERIMENTAL

Patients going through elective hip or knee replacement surgery with spinal anesthesia will receive Gabapentin enacarbil for 5 days

Drug: Gabapentin enacarbil

Placebo

PLACEBO COMPARATOR

Patients going through elective hip or knee replacement surgery with spinal anesthesia will receive placebo for 5 days

Drug: Placebo

Interventions

Gabapentin enacarbil DRUG

600 mg BID 1 day pre-op and 2 hours before surgery, 6 hours after surgery, 600 mg BID 3 days post-operative

Also known as: Xenoport

Gabapentin enacarbil

Placebo DRUG

600 mg BID taken 1 day pre-op and 2 hours before surgery, 6 hours after surgery, 600 mg 3 days post-operative

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Pain

Interventions

1-(((alpha-isobutanoyloxyethoxy)carbonyl)aminomethyl)-1-cyclohexaneacetic acid

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Fabio Rodriguez
• Organization: Cleveland Clinic

rodrigf3@ccf.org

216444-9950

Study Officials

• Daniel Sessler, M.D.

  The Cleveland Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: July 21, 2016
• Study Start: January 1, 2016
• Primary Completion: November 30, 2018
• Study Completion: April 23, 2021
• Last Updated: January 9, 2024
• Results First Posted: January 9, 2024

Record last verified: 2024-01

Locations

US (1)