Trial Outcomes & Findings for Gabapentin on Postoperative Pain Associated With Ureteroscopy and Stents Insertion (NCT NCT03151746)
NCT ID: NCT03151746
Last Updated: 2022-07-21
Results Overview
Total morphine equivalents in milligrams consumed during the first 48 hours after surgery.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
Up to 48 hours after surgery
Results posted on
2022-07-21
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo pill administered 1 hour before planned surgical procedure
Placebo: Placebo pill administered orally 1 hour before planned surgical procedure
|
Gabapentin
Gabapentin pill (1200mg) administered orally 1 hour prior to planned surgical procedure
Gabapentin: Gabapentin pill (1200mg) administered orally 1 hour before planned surgical procedure
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
11
|
|
Overall Study
COMPLETED
|
9
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gabapentin on Postoperative Pain Associated With Ureteroscopy and Stents Insertion
Baseline characteristics by cohort
| Measure |
Placebo
n=9 Participants
Placebo pill administered 1 hour before planned surgical procedure
Placebo: Placebo pill administered orally 1 hour before planned surgical procedure
|
Gabapentin
n=11 Participants
Gabapentin pill (1200mg) administered orally 1 hour prior to planned surgical procedure
Gabapentin: Gabapentin pill (1200mg) administered orally 1 hour before planned surgical procedure
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 16.4 • n=5 Participants
|
49 years
STANDARD_DEVIATION 14.72 • n=7 Participants
|
49 years
STANDARD_DEVIATION 14.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
11 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Height (Inches)
|
67.2 Inches
STANDARD_DEVIATION 3.27 • n=5 Participants
|
67.7 Inches
STANDARD_DEVIATION 4.33 • n=7 Participants
|
67.5 Inches
STANDARD_DEVIATION 3.89 • n=5 Participants
|
|
Weight (kilograms)
|
89.58 Kilograms
STANDARD_DEVIATION 21.6 • n=5 Participants
|
76.1 Kilograms
STANDARD_DEVIATION 17.48 • n=7 Participants
|
83.4 Kilograms
STANDARD_DEVIATION 19.74 • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 48 hours after surgeryTotal morphine equivalents in milligrams consumed during the first 48 hours after surgery.
Outcome measures
| Measure |
Placebo
n=9 Participants
Placebo pill administered 1 hour before planned surgical procedure
Placebo: Placebo pill administered orally 1 hour before planned surgical procedure
|
Gabapentin
n=11 Participants
Gabapentin pill (1200mg) administered orally 1 hour prior to planned surgical procedure
Gabapentin: Gabapentin pill (1200mg) administered orally 1 hour before planned surgical procedure
|
|---|---|---|
|
48 Hours Morphine Equivalents Consumed.
|
51.87 morphine milligrams
Interval 0.0 to 204.0
|
15.71 morphine milligrams
Interval 0.0 to 48.0
|
SECONDARY outcome
Timeframe: 24 hours after surgeryPain scores using an 11 point numeric pain rating scale 0=no pain 10 = worst pain imaginable
Outcome measures
| Measure |
Placebo
n=9 Participants
Placebo pill administered 1 hour before planned surgical procedure
Placebo: Placebo pill administered orally 1 hour before planned surgical procedure
|
Gabapentin
n=11 Participants
Gabapentin pill (1200mg) administered orally 1 hour prior to planned surgical procedure
Gabapentin: Gabapentin pill (1200mg) administered orally 1 hour before planned surgical procedure
|
|---|---|---|
|
24 Hour Pain Burden
|
4.11 score on a scale
Standard Deviation 2.26
|
3.11 score on a scale
Standard Deviation 2.67
|
SECONDARY outcome
Timeframe: 48 hours after surgical procedurePopulation: 3 in the placebo and 3 in the gabapentin group did not complete the survey at 48 hours post operative.
Evaluate quality of recovery using the Quality of Recovery 40 (QoR 40) questionnaire a 40 question survey scored from 40 ( poor recovery) to 200 high (good recovery) 48 hours after the surgical procedure.
Outcome measures
| Measure |
Placebo
n=6 Participants
Placebo pill administered 1 hour before planned surgical procedure
Placebo: Placebo pill administered orally 1 hour before planned surgical procedure
|
Gabapentin
n=8 Participants
Gabapentin pill (1200mg) administered orally 1 hour prior to planned surgical procedure
Gabapentin: Gabapentin pill (1200mg) administered orally 1 hour before planned surgical procedure
|
|---|---|---|
|
QOR 40 Questionnaire Scores
|
181.3 score on a scale
Interval 160.0 to 198.0
|
187.5 score on a scale
Interval 171.0 to 200.0
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Gabapentin
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=9 participants at risk
Placebo pill administered 1 hour before planned surgical procedure
Placebo: Placebo pill administered orally 1 hour before planned surgical procedure
|
Gabapentin
n=11 participants at risk
Gabapentin pill (1200mg) administered orally 1 hour prior to planned surgical procedure
Gabapentin: Gabapentin pill (1200mg) administered orally 1 hour before planned surgical procedure
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • Number of events 1 • 7 days after surgical procedure.
|
18.2%
2/11 • Number of events 2 • 7 days after surgical procedure.
|
|
Musculoskeletal and connective tissue disorders
Headache
|
0.00%
0/9 • 7 days after surgical procedure.
|
18.2%
2/11 • Number of events 11 • 7 days after surgical procedure.
|
|
General disorders
Dizziness
|
11.1%
1/9 • Number of events 1 • 7 days after surgical procedure.
|
18.2%
2/11 • Number of events 2 • 7 days after surgical procedure.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place