Trial Outcomes & Findings for Effect of Perioperative Gabapentin on Postoperative Opioid Requirements (NCT NCT05494385)
NCT ID: NCT05494385
Last Updated: 2024-10-23
Results Overview
Percentage of patients requiring an opioid prescription at discharge in each group. Patients who use 5 or more doses of PRN opioids during inpatient postoperative course will receive a prescription for opioids.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
114 participants
Primary outcome timeframe
Length of postoperative hospital stay (at discharge, an average of 32 hours from time of registration for surgery)
Results posted on
2024-10-23
Participant Flow
Participant milestones
| Measure |
Preoperative Gabapentin/Postoperative Placebo
Preoperative Gabapentin/Postoperative Placebo: Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to placebo every 12 hours. The placebo is encapsulated to appear identical to the active drug. This group will have oxycodone 5 mg every 6 hours as needed for pain.
|
Preoperative Gabapentin/Postoperative Gabapentin
Preoperative Gabapentin/Postoperative Gabapentin: Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to gabapentin every 12 hours. The gabapentin is encapsulated to appear identical to the placebo. This group will have oxycodone 5 mg every 6 hours as needed for pain.
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
55
|
|
Overall Study
COMPLETED
|
59
|
55
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Perioperative Gabapentin on Postoperative Opioid Requirements
Baseline characteristics by cohort
| Measure |
Preoperative Gabapentin/Postoperative Placebo
n=59 Participants
Preoperative Gabapentin/Postoperative Placebo: Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to placebo every 12 hours. The placebo is encapsulated to appear identical to the active drug. This group will have oxycodone 5 mg every 6 hours as needed for pain.
|
Preoperative Gabapentin/Postoperative Gabapentin
n=55 Participants
Preoperative Gabapentin/Postoperative Gabapentin: Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to gabapentin every 12 hours. The gabapentin is encapsulated to appear identical to the placebo. This group will have oxycodone 5 mg every 6 hours as needed for pain.
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.4 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
59.8 years
STANDARD_DEVIATION 12.9 • n=7 Participants
|
59.6 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
54 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Length of postoperative hospital stay (at discharge, an average of 32 hours from time of registration for surgery)Percentage of patients requiring an opioid prescription at discharge in each group. Patients who use 5 or more doses of PRN opioids during inpatient postoperative course will receive a prescription for opioids.
Outcome measures
| Measure |
Preoperative Gabapentin/Postoperative Placebo
n=59 Participants
Preoperative Gabapentin/Postoperative Placebo: Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to placebo every 12 hours. The placebo is encapsulated to appear identical to the active drug. This group will have oxycodone 5 mg every 6 hours as needed for pain.
|
Preoperative Gabapentin/Postoperative Gabapentin
n=55 Participants
Preoperative Gabapentin/Postoperative Gabapentin: Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to gabapentin every 12 hours. The gabapentin is encapsulated to appear identical to the placebo. This group will have oxycodone 5 mg every 6 hours as needed for pain.
|
|---|---|---|
|
Opioid Prescription at Discharge
Opioid prescription at discharge
|
40 Participants
|
40 Participants
|
|
Opioid Prescription at Discharge
No opioid prescription at discharge
|
19 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 6 weeksNumber of patients in each group who call the office to request a new opioid prescription (if they were discharged without a prescription) or to request an opioid prescription refill (if they were discharged with a prescription) within the 6-week postoperative time period.
Outcome measures
| Measure |
Preoperative Gabapentin/Postoperative Placebo
n=59 Participants
Preoperative Gabapentin/Postoperative Placebo: Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to placebo every 12 hours. The placebo is encapsulated to appear identical to the active drug. This group will have oxycodone 5 mg every 6 hours as needed for pain.
|
Preoperative Gabapentin/Postoperative Gabapentin
n=55 Participants
Preoperative Gabapentin/Postoperative Gabapentin: Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to gabapentin every 12 hours. The gabapentin is encapsulated to appear identical to the placebo. This group will have oxycodone 5 mg every 6 hours as needed for pain.
|
|---|---|---|
|
Opioid Refill Requests
Refill/new opioid prescription within 6 weeks
|
50 Participants
|
49 Participants
|
|
Opioid Refill Requests
No refill/new opioid prescription within 6 weeks
|
9 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Length of postoperative hospital stay (an average of 32 hours following surgery)Pain scores in the hospital will be measured on a numeric rating scale (0-10) with 0 being no pain and 10 being worst pain. Highest pain score recorded.
Outcome measures
| Measure |
Preoperative Gabapentin/Postoperative Placebo
n=59 Participants
Preoperative Gabapentin/Postoperative Placebo: Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to placebo every 12 hours. The placebo is encapsulated to appear identical to the active drug. This group will have oxycodone 5 mg every 6 hours as needed for pain.
|
Preoperative Gabapentin/Postoperative Gabapentin
n=55 Participants
Preoperative Gabapentin/Postoperative Gabapentin: Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to gabapentin every 12 hours. The gabapentin is encapsulated to appear identical to the placebo. This group will have oxycodone 5 mg every 6 hours as needed for pain.
|
|---|---|---|
|
Inpatient Pain Scores
|
6 units on a scale
Interval 5.0 to 8.0
|
7 units on a scale
Interval 4.0 to 8.0
|
SECONDARY outcome
Timeframe: Length of postoperative hospital stay (an average of 32 hours following surgery)Total morphine milligram equivalents used will be calculated by converting total PO and IV opioids used postoperatively until hospital discharge to morphine milligram equivalents using the opioid equianalgesic chart.
Outcome measures
| Measure |
Preoperative Gabapentin/Postoperative Placebo
n=59 Participants
Preoperative Gabapentin/Postoperative Placebo: Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to placebo every 12 hours. The placebo is encapsulated to appear identical to the active drug. This group will have oxycodone 5 mg every 6 hours as needed for pain.
|
Preoperative Gabapentin/Postoperative Gabapentin
n=55 Participants
Preoperative Gabapentin/Postoperative Gabapentin: Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to gabapentin every 12 hours. The gabapentin is encapsulated to appear identical to the placebo. This group will have oxycodone 5 mg every 6 hours as needed for pain.
|
|---|---|---|
|
Inpatient Morphine Milligram Equivalents
|
15 morphine milligram equivalenst
Interval 0.0 to 30.0
|
7.5 morphine milligram equivalenst
Interval 0.0 to 22.5
|
SECONDARY outcome
Timeframe: Time of registration for surgery to time of discharge from hospitalLength of stay will be measured in hours by time of registration for surgery to time of discharge from hospital.
Outcome measures
| Measure |
Preoperative Gabapentin/Postoperative Placebo
n=59 Participants
Preoperative Gabapentin/Postoperative Placebo: Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to placebo every 12 hours. The placebo is encapsulated to appear identical to the active drug. This group will have oxycodone 5 mg every 6 hours as needed for pain.
|
Preoperative Gabapentin/Postoperative Gabapentin
n=55 Participants
Preoperative Gabapentin/Postoperative Gabapentin: Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to gabapentin every 12 hours. The gabapentin is encapsulated to appear identical to the placebo. This group will have oxycodone 5 mg every 6 hours as needed for pain.
|
|---|---|---|
|
Length of Stay
|
32.8 hours
Standard Deviation 7.6
|
31.0 hours
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Length of postoperative hospital stay (an average of 32 hours following surgery)Nausea will be measured by the number of "as needed" antiemetics the patient received postoperatively.
Outcome measures
| Measure |
Preoperative Gabapentin/Postoperative Placebo
n=59 Participants
Preoperative Gabapentin/Postoperative Placebo: Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to placebo every 12 hours. The placebo is encapsulated to appear identical to the active drug. This group will have oxycodone 5 mg every 6 hours as needed for pain.
|
Preoperative Gabapentin/Postoperative Gabapentin
n=55 Participants
Preoperative Gabapentin/Postoperative Gabapentin: Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to gabapentin every 12 hours. The gabapentin is encapsulated to appear identical to the placebo. This group will have oxycodone 5 mg every 6 hours as needed for pain.
|
|---|---|---|
|
Nausea
|
0 antiemetics used
Interval 0.0 to 1.0
|
0 antiemetics used
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: On postoperative day 1 between 6AM and 10AMSedation will be measured by the Stanford Sleepiness Scale. This is a self-administered scale that the patient will complete at 10AM on postoperative day 1.
Outcome measures
| Measure |
Preoperative Gabapentin/Postoperative Placebo
n=48 Participants
Preoperative Gabapentin/Postoperative Placebo: Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to placebo every 12 hours. The placebo is encapsulated to appear identical to the active drug. This group will have oxycodone 5 mg every 6 hours as needed for pain.
|
Preoperative Gabapentin/Postoperative Gabapentin
n=50 Participants
Preoperative Gabapentin/Postoperative Gabapentin: Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to gabapentin every 12 hours. The gabapentin is encapsulated to appear identical to the placebo. This group will have oxycodone 5 mg every 6 hours as needed for pain.
|
|---|---|---|
|
Sedation
Feeling active, vital, alert, or wide awake
|
13 Participants
|
15 Participants
|
|
Sedation
Functioning at high levels, but not at peak; able to concentrate
|
19 Participants
|
15 Participants
|
|
Sedation
Awake, but relaxed; responsive but not fully alert
|
8 Participants
|
12 Participants
|
|
Sedation
Somewhat foggy, let down
|
5 Participants
|
3 Participants
|
|
Sedation
Foggy; losing interest in remaining awake; slowed down
|
2 Participants
|
1 Participants
|
|
Sedation
Sleep, woozy, fighting sleep; prefer to lie down
|
1 Participants
|
4 Participants
|
|
Sedation
No longer fight sleep, sleep onset soon, having dream-like thoughts
|
0 Participants
|
0 Participants
|
Adverse Events
Preoperative Gabapentin/Postoperative Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Preoperative Gabapentin/Postoperative Gabapentin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place