Trial Outcomes & Findings for Study of the Effect of the Drug Gabapentin on Postoperative Pain and Incidence of Postoperative Nausea and Vomiting (NCT NCT00886236)
NCT ID: NCT00886236
Last Updated: 2018-09-20
Results Overview
The amount of intraoperative and postoperative opioids used will be collected and analyzed for the three different arms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
120 hours
Results posted on
2018-09-20
Participant Flow
Participant milestones
| Measure |
1 Preoperative Gabapentin Liquid
Preoperative Gabapentin Elixir (1200 mg) AND Postoperative Placebo Elixir (300 mg x 6 doses)
Gabapentin: Gabapentin 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Placebo 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2)
|
2 Preoperative and Postoperative Gabapentin Liquid
Preoperative Gabapentin Elixir (1200 mg) AND Postoperative Gabapentin Elixir (300 mg x 6 doses)
Gabapentin: Gabapentin 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Gabapentin 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2)
|
3 Preoperative and Postoperative Placebo Liquid
Preoperative Placebo Liquid (1200 mg) AND Postoperative Placebo Elixir (300 mg x 6 doses)
Placebo: Placebo 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Placebo 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2)
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
21
|
21
|
|
Overall Study
COMPLETED
|
18
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the Effect of the Drug Gabapentin on Postoperative Pain and Incidence of Postoperative Nausea and Vomiting
Baseline characteristics by cohort
| Measure |
1 Preoperative Gabapentin Liquid
n=20 Participants
Preoperative Gabapentin Elixir (1200 mg) AND Postoperative Placebo Elixir (300 mg x 6 doses)
Gabapentin: Gabapentin 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Placebo 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2)
|
2 Preoperative and Postoperative Gabapentin Liquid
n=21 Participants
Preoperative Gabapentin Elixir (1200 mg) AND Postoperative Gabapentin Elixir (300 mg x 6 doses)
Gabapentin: Gabapentin 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Gabapentin 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2)
|
3 Preoperative and Postoperative Placebo Liquid
n=21 Participants
Preoperative Placebo Liquid (1200 mg) AND Postoperative Placebo Elixir (300 mg x 6 doses)
Placebo: Placebo 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Placebo 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2)
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Age, Continuous
|
47 years
n=5 Participants
|
47 years
n=7 Participants
|
46 years
n=5 Participants
|
47 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
21 participants
n=7 Participants
|
21 participants
n=5 Participants
|
62 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 120 hoursThe amount of intraoperative and postoperative opioids used will be collected and analyzed for the three different arms.
Outcome measures
| Measure |
1 Preoperative Gabapentin Liquid
n=20 Participants
Preoperative Gabapentin Elixir (1200 mg) AND Postoperative Placebo Elixir (300 mg x 6 doses)
Gabapentin: Gabapentin 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Placebo 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2)
|
2 Preoperative and Postoperative Gabapentin Liquid
n=21 Participants
Preoperative Gabapentin Elixir (1200 mg) AND Postoperative Gabapentin Elixir (300 mg x 6 doses)
Gabapentin: Gabapentin 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Gabapentin 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2)
|
3 Preoperative and Postoperative Placebo Liquid
n=21 Participants
Preoperative Placebo Liquid (1200 mg) AND Postoperative Placebo Elixir (300 mg x 6 doses)
Placebo: Placebo 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Placebo 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2)
|
|---|---|---|---|
|
Evaluate the Amount of Diluadid Given Postoperatively
|
11.035 ml
Interval 0.4 to 28.7
|
8.7 ml
Interval 1.0 to 30.6
|
12.4 ml
Interval 0.9 to 30.6
|
PRIMARY outcome
Timeframe: 120 hoursOutcome measures
| Measure |
1 Preoperative Gabapentin Liquid
n=20 Participants
Preoperative Gabapentin Elixir (1200 mg) AND Postoperative Placebo Elixir (300 mg x 6 doses)
Gabapentin: Gabapentin 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Placebo 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2)
|
2 Preoperative and Postoperative Gabapentin Liquid
n=21 Participants
Preoperative Gabapentin Elixir (1200 mg) AND Postoperative Gabapentin Elixir (300 mg x 6 doses)
Gabapentin: Gabapentin 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Gabapentin 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2)
|
3 Preoperative and Postoperative Placebo Liquid
n=21 Participants
Preoperative Placebo Liquid (1200 mg) AND Postoperative Placebo Elixir (300 mg x 6 doses)
Placebo: Placebo 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Placebo 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2)
|
|---|---|---|---|
|
Number of Participants Who Experience Incidence of Postoperative Nausea.
|
12 Participants
|
11 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 48 hoursOutcome measures
| Measure |
1 Preoperative Gabapentin Liquid
n=20 Participants
Preoperative Gabapentin Elixir (1200 mg) AND Postoperative Placebo Elixir (300 mg x 6 doses)
Gabapentin: Gabapentin 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Placebo 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2)
|
2 Preoperative and Postoperative Gabapentin Liquid
n=21 Participants
Preoperative Gabapentin Elixir (1200 mg) AND Postoperative Gabapentin Elixir (300 mg x 6 doses)
Gabapentin: Gabapentin 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Gabapentin 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2)
|
3 Preoperative and Postoperative Placebo Liquid
n=21 Participants
Preoperative Placebo Liquid (1200 mg) AND Postoperative Placebo Elixir (300 mg x 6 doses)
Placebo: Placebo 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Placebo 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2)
|
|---|---|---|---|
|
Evaluate Incidence of Respiratory Depression as Evidenced by Pulse Oximetry Data
|
93 % oxygen saturation
Interval 69.0 to 97.0
|
94 % oxygen saturation
Interval 88.0 to 100.0
|
95 % oxygen saturation
Interval 88.0 to 98.0
|
Adverse Events
1 Preoperative Gabapentin Liquid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2 Preoperative and Postoperative Gabapentin Liquid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3 Preoperative and Postoperative Placebo Liquid
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