Gabapentin Regimens and Their Effects on Opioid Consumption
Condition: Knee Osteoarthritis; Knee Pain Chronic; Opioid Use; Opioid Dependence
MeSH terms: Opioid-Related Disorders
Intervention: Gabapentin
Intervention description: 600 mg gabapentin before and after surgery. 300 mg gabapentin for approx. 5 weeks after surgery.
Intervention MeSH terms: Gabapentin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two-arm parallel design.
Masking: None (Open Label)
Enrollment: 77.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Total Knee Arthroplasty; Neurontin; Gabapentin; Opioid Tapering

Summary:

      The purpose of this study is to determine the best strategy of administering gabapentin in
      connection with our current approach to perioperative pain management. We aim to evaluate two
      different adjunct gabapentin regimens given in the perioperative period, and to identify
      which manages patient pain more effectively and safely. In this evaluation, we will identify
      the quantity of patients' opioid consumption, the quality of their pain management, and the
      frequency and severity of any side effects they might experience.

      Patients who are undergoing total knee replacement (TKR) and choose to participate will be
      randomly assigned to a treatment group using computer-generated randomization. Patients in
      group 1 (the control group) will receive the standard of care as pertains to gabapentin. This
      consists of a single 600 mg dose of gabapentin administered to the patient approximately one
      to two hours before surgery, then a dose of 600 mg each morning during postoperative
      admission. Patients in Group 2 will receive 600 mg preoperatively, plus an additional
      postoperative gabapentin regimen: they will take 300 mg of gabapentin every 8 hours for 1
      week, then a single nightly dose of 300 mg for another month.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age

          -  Receiving surgery for total knee replacement (TKR)

          -  Opioid naïve

          -  Agrees to use tracking diary to monitor opioid consumption

        Exclusion Criteria:

          -  Over 75 years of age on the date of surgery

          -  If female, pregnant

          -  Has received investigational articles < 30 days prior to enrollment or is currently
             receiving investigational products or devices

          -  Chronic pain syndrome

          -  Taking chronic narcotics and/or taking more than 10 mg of codeine per day, any amount
             of Hydrocodone, over 200 mg of tramadol per day, or any other narcotics prescribed for
             moderate or severe pain

          -  Involved in pain clinics for chronic pain, or pain that is not related to the surgical
             site

          -  On long-term gabapentin regimen

          -  Taking Lyrica or Gralise

          -  Known history of depression or has been treated for depression with medication

          -  Has entertained suicidal thoughts and behaviors