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Gabapentin Regimens and Their Effects on Opioid Consumption

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03334903
Collaborator
(none)
77
Enrollment
1
Location
2
Arms
11.3
Actual Duration (Months)
6.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

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. The target enrollment is 68.

Patients who are undergoing total knee replacement (TKR) at Brigham and Women's Hospital will be informed about the study and asked whether they would like to participate. Upon agreement, a patient will sign his/her consent and will be assigned to a treatment group. 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.

Every patient being discharged from the hospital will receive from the nursing staff verbal and written instructions - the latter of which will be either printed or in electronic form - about narcotic medications. The instructions will explain when to use such medications and how to taper off their consumption. Following discharge, patients will take gabapentin as directed by their discharge instructions, and in the process track their opioid consumption on their own in their diaries. They will also document their pain, nausea and satisfaction levels according to the visual analogue scale (VAS). At the first post-operative appointment, patients' levels of opioid use will be verified and compared to the amount recorded in each diary; the actual number of tablets consumed will be compared with the documented amounts and with the prescriptions they received. Patients receiving a new prescription will also receive a matching diary for the total length of opioid treatment, including further directions on how to wean themselves off their medications. Outcome measures will be collected at both post-operative visits, the first occurring 8-10 days after surgery and the second 2-3 months following. Additional data including length of stay, postoperative complications including infection and readmission, Emergency Department visits, and routinely collected postoperative functional outcome measures (PROMs) will be recorded.

The Principal Investigator (PI) will review all drug consumption data and patient-reported outcome measures with the research assistant (RA) on a monthly basis as it is collected. The PI will participate in the collection of outcome data at the first and second postoperative visits. Data which could indicate a potential complication, whether related to the study or not - such as heightened risk of adverse outcomes or non-compliance with the tracking diary - will be addressed by the PI immediately. The PI will determine if the study should be altered in any way or stopped for safety reasons. Reasons for stoppage include a rate of adverse events greater than 10% in either group. Adverse events of primary concern include:

  • Excessive sleepiness

  • Allergic reactions to the opioid medications or gabapentin

All adverse events are recorded in an adverse event log, which will be kept by the RA throughout the study. The PI will review the data on a monthly basis, as well as whenever the RA alerts the PI to any potential adverse event. These checks will help to ensure validity and patient safety. Unanticipated problems will be reported to the PHRC in accordance with PHRC guidelines.

Study Design

Study Type:
Interventional
Actual Enrollment :
77 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two-arm parallel design.Two-arm parallel design.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Gabapentin Regimens and Their Effects on Opioid Consumption
Actual Study Start Date :
May 15, 2018
Actual Primary Completion Date :
Apr 24, 2019
Actual Study Completion Date :
Apr 24, 2019

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Standard of Care

Standard of care includes one dose of 600 mg gabapentin in the immediate preoperative period (1-2 hours before surgery), then a dose of 600 mg each morning during postoperative admission.
Experimental: Postoperative Gabapentin Regimen

Single preoperative dose of 600 mg, as described above, plus an additional postoperative regimen. Patients will take 300 mg gabapentin every 8 hours for 1 week after discharge, then a single nightly dose of 300 mg gabapentin for another month.

Drug: Gabapentin
600 mg gabapentin before and after surgery. 300 mg gabapentin for approx. 5 weeks after surgery.
Other Names:
  • Neurontin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Opioid Consumption [2-3 months following surgery (total amount measured at second postoperative appointment; means assessed afterwards).]

      Mean opioid consumption, measured in mg of morphine equivalents.

    Secondary Outcome Measures

    1. Days Taking Opioids [2-3 months following surgery (measured at second postoperative appointment).]

      Number of days until patients are finished consuming opioid medications after discharge.

    2. VAS Score 1: "How Much Pain do You Feel in Your Operative Site When Resting?" [2-3 months after surgery (at 2nd postoperative appointment)]

      Surgical site pain. Scale 0-10, with 0 best and 10 worst

    3. VAS Score 2: "How Much Pain do You Feel in Your Operative Site When Moving?" [2-3 months following surgery (measured at second postoperative appointment).]

      Surgical site pain. Scale 0-10, with 0 best and 10 worst.

    4. VAS Score 3: "How Well Are You Sleeping?" [2-3 months following surgery (measured at second postoperative appointment).]

      Sleep quality. Scale 0-10 with 0 worst and 10 best.

    5. VAS Score 4: "How Bad is Your Nausea?" [2-3 months following surgery (measured at second postoperative appointment).]

      Nausea. Scale 0-10, with 0 best and 10 worst.

    6. VAS Score 5: "How Satisfied Are You With Your Pain Management?" [2-3 months following surgery (measured at second postoperative appointment).]

      Satisfaction. Scale 0-10 with 0 worst and 10 best.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Brigham and Women's Faulkner Hospital Boston Massachusetts United States 02130

    Sponsors and Collaborators

    • Brigham and Women's Hospital

    Investigators

    • Principal Investigator: Wolfgang Fitz, M.D., Brigham and Women's Hospital

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Wolfgang Fitz, M.D., Associate Orthopedic Surgeon, Brigham and Women's Hospital
    ClinicalTrials.gov Identifier:
    NCT03334903
    Other Study ID Numbers:
    • OpioidNeurontinTKR
    First Posted:
    Nov 7, 2017
    Last Update Posted:
    Feb 18, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Wolfgang Fitz, M.D., Associate Orthopedic Surgeon, Brigham and Women's Hospital
    Total Knee Arthroplasty
    Neurontin
    Gabapentin
    Opioid Tapering
    Additional relevant MeSH terms:
    Osteoarthritis, Knee
    Opioid-Related Disorders
    Gabapentin

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Standard of Care Postoperative Gabapentin Regimen
    Arm/Group Description Standard of care includes one dose of 600 mg gabapentin in the immediate preoperative period (1-2 hours before surgery), then a dose of 600 mg each morning during postoperative admission. Single preoperative dose of 600 mg, as described above, plus an additional postoperative regimen. Patients will take 300 mg gabapentin every 8 hours for 1 week after discharge, then a single nightly dose of 300 mg gabapentin for another month. Gabapentin: 600 mg gabapentin before and after surgery. 300 mg gabapentin for approx. 5 weeks after surgery.
    Period Title: Overall Study
    STARTED 39 38
    COMPLETED 35 33
    NOT COMPLETED 4 5

    Baseline Characteristics

    Arm/Group Title Standard of Care Postoperative Gabapentin Regimen Total
    Arm/Group Description Standard of care includes one dose of 600 mg gabapentin in the immediate preoperative period (1-2 hours before surgery), then a dose of 600 mg each morning during postoperative admission. Single preoperative dose of 600 mg, as described above, plus an additional postoperative regimen. Patients will take 300 mg gabapentin every 8 hours for 1 week after discharge, then a single nightly dose of 300 mg gabapentin for another month. Gabapentin: 600 mg gabapentin before and after surgery. 300 mg gabapentin for approx. 5 weeks after surgery. Total of all reporting groups
    Overall Participants 35 33 68
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    64.6
    (6.8)
    64.2
    (6.7)
    64.4
    (6.7)
    Sex: Female, Male (Count of Participants)
    Female
    18
    51.4%
    17
    51.5%
    35
    51.5%
    Male
    17
    48.6%
    16
    48.5%
    33
    48.5%
    Race and Ethnicity Not Collected (Count of Participants)
    Count of Participants [Participants]
    0
    0%
    BMI (kg/m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m^2]
    30.3
    (4.5)
    32.1
    (5.3)
    31.2
    (5.0)

    Outcome Measures

    1. Primary Outcome
    Title Opioid Consumption
    Description Mean opioid consumption, measured in mg of morphine equivalents.
    Time Frame 2-3 months following surgery (total amount measured at second postoperative appointment; means assessed afterwards).

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Standard of Care Postoperative Gabapentin Regimen
    Arm/Group Description Standard of care includes one dose of 600 mg gabapentin in the immediate preoperative period (1-2 hours before surgery), then a dose of 600 mg each morning during postoperative admission. Single preoperative dose of 600 mg, as described above, plus an additional postoperative regimen. Patients will take 300 mg gabapentin every 8 hours for 1 week after discharge, then a single nightly dose of 300 mg gabapentin for another month. Gabapentin: 600 mg gabapentin before and after surgery. 300 mg gabapentin for approx. 5 weeks after surgery.
    Measure Participants 35 33
    Mean (Standard Deviation) [morphine equivalents]
    287.0
    (227.99)
    281.1
    (230.31)
    2. Secondary Outcome
    Title Days Taking Opioids
    Description Number of days until patients are finished consuming opioid medications after discharge.
    Time Frame 2-3 months following surgery (measured at second postoperative appointment).

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Standard of Care Postoperative Gabapentin Regimen
    Arm/Group Description Standard of care includes one dose of 600 mg gabapentin in the immediate preoperative period (1-2 hours before surgery), then a dose of 600 mg each morning during postoperative admission. Single preoperative dose of 600 mg, as described above, plus an additional postoperative regimen. Patients will take 300 mg gabapentin every 8 hours for 1 week after discharge, then a single nightly dose of 300 mg gabapentin for another month. Gabapentin: 600 mg gabapentin before and after surgery. 300 mg gabapentin for approx. 5 weeks after surgery.
    Measure Participants 35 33
    Mean (Standard Deviation) [days]
    14.8
    (10.69)
    18.7
    (18.57)
    3. Secondary Outcome
    Title VAS Score 1: "How Much Pain do You Feel in Your Operative Site When Resting?"
    Description Surgical site pain. Scale 0-10, with 0 best and 10 worst
    Time Frame 2-3 months after surgery (at 2nd postoperative appointment)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Standard of Care Postoperative Gabapentin Regimen
    Arm/Group Description Standard of care includes one dose of 600 mg gabapentin in the immediate preoperative period (1-2 hours before surgery), then a dose of 600 mg each morning during postoperative admission. Single preoperative dose of 600 mg, as described above, plus an additional postoperative regimen. Patients will take 300 mg gabapentin every 8 hours for 1 week after discharge, then a single nightly dose of 300 mg gabapentin for another month. Gabapentin: 600 mg gabapentin before and after surgery. 300 mg gabapentin for approx. 5 weeks after surgery.
    Measure Participants 35 33
    Mean (Standard Deviation) [score on 10-point scale]
    2.26
    (1.36)
    2.46
    (1.57)
    4. Secondary Outcome
    Title VAS Score 2: "How Much Pain do You Feel in Your Operative Site When Moving?"
    Description Surgical site pain. Scale 0-10, with 0 best and 10 worst.
    Time Frame 2-3 months following surgery (measured at second postoperative appointment).

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Standard of Care Postoperative Gabapentin Regimen
    Arm/Group Description Standard of care includes one dose of 600 mg gabapentin in the immediate preoperative period (1-2 hours before surgery), then a dose of 600 mg each morning during postoperative admission. Single preoperative dose of 600 mg, as described above, plus an additional postoperative regimen. Patients will take 300 mg gabapentin every 8 hours for 1 week after discharge, then a single nightly dose of 300 mg gabapentin for another month. Gabapentin: 600 mg gabapentin before and after surgery. 300 mg gabapentin for approx. 5 weeks after surgery.
    Measure Participants 35 33
    Mean (Standard Deviation) [score on a 10-point scale]
    3.84
    (1.54)
    3.54
    (1.54)
    5. Secondary Outcome
    Title VAS Score 3: "How Well Are You Sleeping?"
    Description Sleep quality. Scale 0-10 with 0 worst and 10 best.
    Time Frame 2-3 months following surgery (measured at second postoperative appointment).

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Standard of Care Postoperative Gabapentin Regimen
    Arm/Group Description Standard of care includes one dose of 600 mg gabapentin in the immediate preoperative period (1-2 hours before surgery), then a dose of 600 mg each morning during postoperative admission. Single preoperative dose of 600 mg, as described above, plus an additional postoperative regimen. Patients will take 300 mg gabapentin every 8 hours for 1 week after discharge, then a single nightly dose of 300 mg gabapentin for another month. Gabapentin: 600 mg gabapentin before and after surgery. 300 mg gabapentin for approx. 5 weeks after surgery.
    Measure Participants 35 33
    Mean (Standard Deviation) [score on a 10-point scale]
    5.73
    (2.16)
    6.38
    (1.75)
    6. Secondary Outcome
    Title VAS Score 4: "How Bad is Your Nausea?"
    Description Nausea. Scale 0-10, with 0 best and 10 worst.
    Time Frame 2-3 months following surgery (measured at second postoperative appointment).

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Standard of Care Postoperative Gabapentin Regimen
    Arm/Group Description Standard of care includes one dose of 600 mg gabapentin in the immediate preoperative period (1-2 hours before surgery), then a dose of 600 mg each morning during postoperative admission. Single preoperative dose of 600 mg, as described above, plus an additional postoperative regimen. Patients will take 300 mg gabapentin every 8 hours for 1 week after discharge, then a single nightly dose of 300 mg gabapentin for another month. Gabapentin: 600 mg gabapentin before and after surgery. 300 mg gabapentin for approx. 5 weeks after surgery.
    Measure Participants 35 33
    Mean (Standard Deviation) [score on a 10-point scale]
    0.36
    (0.53)
    0.17
    (0.40)
    7. Secondary Outcome
    Title VAS Score 5: "How Satisfied Are You With Your Pain Management?"
    Description Satisfaction. Scale 0-10 with 0 worst and 10 best.
    Time Frame 2-3 months following surgery (measured at second postoperative appointment).

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Standard of Care Postoperative Gabapentin Regimen
    Arm/Group Description Standard of care includes one dose of 600 mg gabapentin in the immediate preoperative period (1-2 hours before surgery), then a dose of 600 mg each morning during postoperative admission. Single preoperative dose of 600 mg, as described above, plus an additional postoperative regimen. Patients will take 300 mg gabapentin every 8 hours for 1 week after discharge, then a single nightly dose of 300 mg gabapentin for another month. Gabapentin: 600 mg gabapentin before and after surgery. 300 mg gabapentin for approx. 5 weeks after surgery.
    Measure Participants 35 33
    Mean (Standard Deviation) [score on a 10-point scale]
    7.83
    (2.23)
    8.48
    (1.39)

    Adverse Events

    Time Frame Adverse events collected through study completion, an average of 3 months
    Adverse Event Reporting Description
    Arm/Group Title Standard of Care Postoperative Gabapentin Regimen
    Arm/Group Description Standard of care includes one dose of 600 mg gabapentin in the immediate preoperative period (1-2 hours before surgery), then a dose of 600 mg each morning during postoperative admission. Single preoperative dose of 600 mg, as described above, plus an additional postoperative regimen. Patients will take 300 mg gabapentin every 8 hours for 1 week after discharge, then a single nightly dose of 300 mg gabapentin for another month. Gabapentin: 600 mg gabapentin before and after surgery. 300 mg gabapentin for approx. 5 weeks after surgery.
    All Cause Mortality
    Standard of Care Postoperative Gabapentin Regimen
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/39 (0%) 0/38 (0%)
    Serious Adverse Events
    Standard of Care Postoperative Gabapentin Regimen
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/39 (0%) 0/38 (0%)
    Other (Not Including Serious) Adverse Events
    Standard of Care Postoperative Gabapentin Regimen
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/39 (2.6%) 1/38 (2.6%)
    Gastrointestinal disorders
    GI Distress 1/39 (2.6%) 1 0/38 (0%) 0
    General disorders
    Dizziness 0/39 (0%) 0 1/38 (2.6%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Wolfgang Fitz
    Organization Brigham and Women's Hospital
    Phone 6177325500
    Email wfitz@bwh.harvard.edu
    Responsible Party:
    Wolfgang Fitz, M.D., Associate Orthopedic Surgeon, Brigham and Women's Hospital
    ClinicalTrials.gov Identifier:
    NCT03334903
    Other Study ID Numbers:
    • OpioidNeurontinTKR
    First Posted:
    Nov 7, 2017
    Last Update Posted:
    Feb 18, 2021
    Last Verified:
    Feb 1, 2021