Trial Outcomes & Findings for Gabapentin Regimens and Their Effects on Opioid Consumption (NCT NCT03334903)
NCT ID: NCT03334903
Last Updated: 2021-02-18
Results Overview
Mean opioid consumption, measured in mg of morphine equivalents.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
77 participants
Primary outcome timeframe
2-3 months following surgery (total amount measured at second postoperative appointment; means assessed afterwards).
Results posted on
2021-02-18
Participant Flow
Participant milestones
| Measure |
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.
|
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.
Gabapentin: 600 mg gabapentin before and after surgery. 300 mg gabapentin for approx. 5 weeks after surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
38
|
|
Overall Study
COMPLETED
|
35
|
33
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
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.
|
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.
Gabapentin: 600 mg gabapentin before and after surgery. 300 mg gabapentin for approx. 5 weeks after surgery.
|
|---|---|---|
|
Overall Study
Use of medical marijuana - determined ineligible later in study
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
3
|
|
Overall Study
Surgery postponed
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
68 total patients completed study, after dropout of 9 total participants from overall number enrolled
Baseline characteristics by cohort
| Measure |
Standard of Care
n=35 Participants
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.
|
Postoperative Gabapentin Regimen
n=33 Participants
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
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.6 years
STANDARD_DEVIATION 6.8 • n=35 Participants • 68 total patients completed study, after dropout of 9 total participants from overall number enrolled
|
64.2 years
STANDARD_DEVIATION 6.7 • n=33 Participants • 68 total patients completed study, after dropout of 9 total participants from overall number enrolled
|
64.4 years
STANDARD_DEVIATION 6.7 • n=68 Participants • 68 total patients completed study, after dropout of 9 total participants from overall number enrolled
|
|
Sex: Female, Male
Female
|
18 Participants
n=35 Participants
|
17 Participants
n=33 Participants
|
35 Participants
n=68 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=35 Participants
|
16 Participants
n=33 Participants
|
33 Participants
n=68 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
BMI
|
30.3 kg/m^2
STANDARD_DEVIATION 4.5 • n=35 Participants
|
32.1 kg/m^2
STANDARD_DEVIATION 5.3 • n=33 Participants
|
31.2 kg/m^2
STANDARD_DEVIATION 5.0 • n=68 Participants
|
PRIMARY outcome
Timeframe: 2-3 months following surgery (total amount measured at second postoperative appointment; means assessed afterwards).Mean opioid consumption, measured in mg of morphine equivalents.
Outcome measures
| Measure |
Standard of Care
n=35 Participants
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.
|
Postoperative Gabapentin Regimen
n=33 Participants
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.
|
|---|---|---|
|
Opioid Consumption
|
287.0 morphine equivalents
Standard Deviation 227.99
|
281.1 morphine equivalents
Standard Deviation 230.31
|
SECONDARY outcome
Timeframe: 2-3 months following surgery (measured at second postoperative appointment).Number of days until patients are finished consuming opioid medications after discharge.
Outcome measures
| Measure |
Standard of Care
n=35 Participants
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.
|
Postoperative Gabapentin Regimen
n=33 Participants
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.
|
|---|---|---|
|
Days Taking Opioids
|
14.8 days
Standard Deviation 10.69
|
18.7 days
Standard Deviation 18.57
|
SECONDARY outcome
Timeframe: 2-3 months after surgery (at 2nd postoperative appointment)Surgical site pain. Scale 0-10, with 0 best and 10 worst
Outcome measures
| Measure |
Standard of Care
n=35 Participants
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.
|
Postoperative Gabapentin Regimen
n=33 Participants
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.
|
|---|---|---|
|
VAS Score 1: "How Much Pain do You Feel in Your Operative Site When Resting?"
|
2.26 score on 10-point scale
Standard Deviation 1.36
|
2.46 score on 10-point scale
Standard Deviation 1.57
|
SECONDARY outcome
Timeframe: 2-3 months following surgery (measured at second postoperative appointment).Surgical site pain. Scale 0-10, with 0 best and 10 worst.
Outcome measures
| Measure |
Standard of Care
n=35 Participants
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.
|
Postoperative Gabapentin Regimen
n=33 Participants
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.
|
|---|---|---|
|
VAS Score 2: "How Much Pain do You Feel in Your Operative Site When Moving?"
|
3.84 score on a 10-point scale
Standard Deviation 1.54
|
3.54 score on a 10-point scale
Standard Deviation 1.54
|
SECONDARY outcome
Timeframe: 2-3 months following surgery (measured at second postoperative appointment).Sleep quality. Scale 0-10 with 0 worst and 10 best.
Outcome measures
| Measure |
Standard of Care
n=35 Participants
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.
|
Postoperative Gabapentin Regimen
n=33 Participants
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.
|
|---|---|---|
|
VAS Score 3: "How Well Are You Sleeping?"
|
5.73 score on a 10-point scale
Standard Deviation 2.16
|
6.38 score on a 10-point scale
Standard Deviation 1.75
|
SECONDARY outcome
Timeframe: 2-3 months following surgery (measured at second postoperative appointment).Nausea. Scale 0-10, with 0 best and 10 worst.
Outcome measures
| Measure |
Standard of Care
n=35 Participants
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.
|
Postoperative Gabapentin Regimen
n=33 Participants
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.
|
|---|---|---|
|
VAS Score 4: "How Bad is Your Nausea?"
|
0.36 score on a 10-point scale
Standard Deviation 0.53
|
0.17 score on a 10-point scale
Standard Deviation 0.40
|
SECONDARY outcome
Timeframe: 2-3 months following surgery (measured at second postoperative appointment).Satisfaction. Scale 0-10 with 0 worst and 10 best.
Outcome measures
| Measure |
Standard of Care
n=35 Participants
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.
|
Postoperative Gabapentin Regimen
n=33 Participants
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.
|
|---|---|---|
|
VAS Score 5: "How Satisfied Are You With Your Pain Management?"
|
7.83 score on a 10-point scale
Standard Deviation 2.23
|
8.48 score on a 10-point scale
Standard Deviation 1.39
|
Adverse Events
Standard of Care
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Postoperative Gabapentin Regimen
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard of Care
n=39 participants at risk
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.
|
Postoperative Gabapentin Regimen
n=38 participants at risk
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.
|
|---|---|---|
|
General disorders
Dizziness
|
0.00%
0/39 • Adverse events collected through study completion, an average of 3 months
|
2.6%
1/38 • Number of events 1 • Adverse events collected through study completion, an average of 3 months
|
|
Gastrointestinal disorders
GI Distress
|
2.6%
1/39 • Number of events 1 • Adverse events collected through study completion, an average of 3 months
|
0.00%
0/38 • Adverse events collected through study completion, an average of 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place