A Phase 4 interventional study of Gabapentin in Knee Osteoarthritis, Knee Pain Chronic and Opioid Use, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-18.
Sponsored by Brigham and Women's Hospital · Phase 4, Interventional, and Treatment
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.
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:
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.
Exclusion Criteria:
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.
Drug: Gabapentin
600 mg gabapentin before and after surgery. 300 mg gabapentin for approx. 5 weeks after surgery.
Also known as: Neurontin
Opioid Consumption
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).
Days Taking Opioids
Number of days until patients are finished consuming opioid medications after discharge.
Time frame: 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?"
Surgical site pain. Scale 0-10, with 0 best and 10 worst
Time frame: 2-3 months after surgery (at 2nd postoperative appointment)
VAS Score 2: "How Much Pain do You Feel in Your Operative Site When Moving?"
Surgical site pain. Scale 0-10, with 0 best and 10 worst.
Time frame: 2-3 months following surgery (measured at second postoperative appointment).
VAS Score 3: "How Well Are You Sleeping?"
Sleep quality. Scale 0-10 with 0 worst and 10 best.
Time frame: 2-3 months following surgery (measured at second postoperative appointment).
VAS Score 4: "How Bad is Your Nausea?"
Nausea. Scale 0-10, with 0 best and 10 worst.
Time frame: 2-3 months following surgery (measured at second postoperative appointment).
VAS Score 5: "How Satisfied Are You With Your Pain Management?"
Satisfaction. Scale 0-10 with 0 worst and 10 best.
Time frame: 2-3 months following surgery (measured at second postoperative appointment).
| Milestone | Standard of Care | Postoperative Gabapentin Regimen |
|---|---|---|
| Started | 39 | 38 |
| Completed | 35 | 33 |
| Not completed | 4 | 5 |
| Withdrew: Use of medical marijuana - determined ineligible later in study | 1 | 0 |
| Withdrew: Protocol violation | 1 | 3 |
| Withdrew: Surgery postponed | 1 | 0 |
| Withdrew: Adverse event | 1 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
Mean opioid consumption, measured in mg of morphine equivalents.
| morphine equivalents | Standard of Care | Postoperative Gabapentin Regimen |
|---|---|---|
| Opioid Consumption | 287.0 ± 227.99 | 281.1 ± 230.31 |
Number of days until patients are finished consuming opioid medications after discharge.
| days | Standard of Care | Postoperative Gabapentin Regimen |
|---|---|---|
| Days Taking Opioids | 14.8 ± 10.69 | 18.7 ± 18.57 |
Surgical site pain. Scale 0-10, with 0 best and 10 worst
| score on 10-point scale | Standard of Care | Postoperative Gabapentin Regimen |
|---|---|---|
| VAS Score 1: "How Much Pain do You Feel in Your Operative Site When Resting?" | 2.26 ± 1.36 | 2.46 ± 1.57 |
Surgical site pain. Scale 0-10, with 0 best and 10 worst.
| score on a 10-point scale | Standard of Care | Postoperative Gabapentin Regimen |
|---|---|---|
| VAS Score 2: "How Much Pain do You Feel in Your Operative Site When Moving?" | 3.84 ± 1.54 | 3.54 ± 1.54 |
Sleep quality. Scale 0-10 with 0 worst and 10 best.
| score on a 10-point scale | Standard of Care | Postoperative Gabapentin Regimen |
|---|---|---|
| VAS Score 3: "How Well Are You Sleeping?" | 5.73 ± 2.16 | 6.38 ± 1.75 |
Nausea. Scale 0-10, with 0 best and 10 worst.
| score on a 10-point scale | Standard of Care | Postoperative Gabapentin Regimen |
|---|---|---|
| VAS Score 4: "How Bad is Your Nausea?" | 0.36 ± 0.53 | 0.17 ± 0.40 |
Satisfaction. Scale 0-10 with 0 worst and 10 best.
| score on a 10-point scale | Standard of Care | Postoperative Gabapentin Regimen |
|---|---|---|
| VAS Score 5: "How Satisfied Are You With Your Pain Management?" | 7.83 ± 2.23 | 8.48 ± 1.39 |
Collected over Adverse events collected through study completion, an average of 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard of Care | 0/39 (0%) | 0/39 (0%) | 1/39 (2.6%) |
| Postoperative Gabapentin Regimen | 0/38 (0%) | 0/38 (0%) | 1/38 (2.6%) |
| Event | Standard of Care | Postoperative Gabapentin Regimen |
|---|---|---|
| DizzinessGeneral disorders | 0/39 | 1/38 |
| GI DistressGastrointestinal disorders | 1/39 | 0/38 |
| Age, Continuous(years) | Standard of Care | Postoperative Gabapentin Regimen | Total |
|---|---|---|---|
| Mean | 64.6 ± 6.8 | 64.2 ± 6.7 | 64.4 ± 6.7 |
| Sex: Female, Male(Participants) | Standard of Care | Postoperative Gabapentin Regimen | Total |
|---|---|---|---|
| Female | 18 | 17 | 35 |
| Male | 17 | 16 | 33 |
| Race and Ethnicity Not Collected(Participants) | Standard of Care | Postoperative Gabapentin Regimen | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| BMI(kg/m^2) | Standard of Care | Postoperative Gabapentin Regimen | Total |
|---|---|---|---|
| Mean | 30.3 ± 4.5 | 32.1 ± 5.3 | 31.2 ± 5.0 |
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