Gabapentin Regimens and Their Effects on Opioid Consumption

February 1, 2021 updated by: Wolfgang Fitz, M.D., Brigham and Women's Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

77

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02130
        • Brigham and Women's Faulkner Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2-3 months following surgery (total amount measured at second postoperative appointment; means assessed afterwards).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2-3 months following surgery (measured at second postoperative appointment).
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
2-3 months after surgery (at 2nd postoperative appointment)
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.
2-3 months following surgery (measured at second postoperative appointment).
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.
2-3 months following surgery (measured at second postoperative appointment).
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.
2-3 months following surgery (measured at second postoperative appointment).
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.
2-3 months following surgery (measured at second postoperative appointment).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2018

Primary Completion (Actual)

April 24, 2019

Study Completion (Actual)

April 24, 2019

Study Registration Dates

First Submitted

November 3, 2017

First Submitted That Met QC Criteria

November 3, 2017

First Posted (Actual)

November 7, 2017

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OpioidNeurontinTKR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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