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Gabapentin Regimens and Their Effects on Opioid Consumption

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ClinicalTrials.gov Identifier: NCT03334903
Recruitment Status : Completed
First Posted : November 7, 2017
Results First Posted : February 18, 2021
Last Update Posted : February 18, 2021
Sponsor:
Information provided by (Responsible Party):
Wolfgang Fitz, M.D., Brigham and Women's Hospital

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
Knee Osteoarthritis Knee Pain Chronic Opioid Use Opioid Dependence Drug: Gabapentin 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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 : April 24, 2019
Actual Study Completion Date : April 24, 2019

Resource links provided by the National Library of Medicine


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 Name: Neurontin




Primary Outcome Measures :
  1. Opioid Consumption [ Time Frame: 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 [ Time Frame: 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?" [ Time Frame: 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?" [ Time Frame: 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?" [ Time Frame: 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?" [ Time Frame: 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?" [ Time Frame: 2-3 months following surgery (measured at second postoperative appointment). ]
    Satisfaction. Scale 0-10 with 0 worst and 10 best.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT03334903


Locations
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United States, Massachusetts
Brigham and Women's Faulkner Hospital
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Wolfgang Fitz, M.D. Brigham and Women's Hospital
  Study Documents (Full-Text)

Documents provided by Wolfgang Fitz, M.D., Brigham and Women's Hospital:
Publications:

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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: November 7, 2017    Key Record Dates
Results First Posted: February 18, 2021
Last Update Posted: February 18, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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., Brigham and Women's Hospital:
Total Knee Arthroplasty
Neurontin
Gabapentin
Opioid Tapering
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Opioid-Related Disorders
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
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