Trial Outcomes & Findings for Effect of Oral Choline Supplementation on Postoperative Pain (NCT NCT00720343)
NCT ID: NCT00720343
Last Updated: 2024-07-09
Results Overview
NRS range is 0-10 where 0 is no pain and 10 is the worst pain imaginable
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
End of surgery, and 1 hour after surgery
Results posted on
2024-07-09
Participant Flow
Participant milestones
| Measure |
Choline
Participants ingested ten tablets (GNC Triple Lecithin 1200 choline tablets) containing 12 g of high choline lecithin and 4.2 g phosphatidyl choline the night before surgery. On the day of surgery, a second dose of study drug (equivalent to ten tablets) was administered by the clinical anesthesiologist as a slurry through the oral gastric tube that was placed after induction of general anesthesia.
|
Placebo
Participants ingested ten gelatin capsules the night before surgery. On the day of surgery, a second dose of the placebo (equivalent to ten capsules) was administered by the clinical anesthesiologist as a slurry through the oral gastric tube that was placed after induction of general anesthesia.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
29
|
28
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Choline
Participants ingested ten tablets (GNC Triple Lecithin 1200 choline tablets) containing 12 g of high choline lecithin and 4.2 g phosphatidyl choline the night before surgery. On the day of surgery, a second dose of study drug (equivalent to ten tablets) was administered by the clinical anesthesiologist as a slurry through the oral gastric tube that was placed after induction of general anesthesia.
|
Placebo
Participants ingested ten gelatin capsules the night before surgery. On the day of surgery, a second dose of the placebo (equivalent to ten capsules) was administered by the clinical anesthesiologist as a slurry through the oral gastric tube that was placed after induction of general anesthesia.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
2
|
Baseline Characteristics
Effect of Oral Choline Supplementation on Postoperative Pain
Baseline characteristics by cohort
| Measure |
Choline
n=29 Participants
Participants ingested ten tablets (GNC Triple Lecithin 1200 choline tablets) containing 12 g of high choline lecithin and 4.2 g phosphatidyl choline the night before surgery. On the day of surgery, a second dose of study drug (equivalent to ten tablets) was administered by the clinical anesthesiologist as a slurry through the oral gastric tube that was placed after induction of general anesthesia.
|
Placebo
n=28 Participants
Participants ingested ten gelatin capsules the night before surgery. On the day of surgery, a second dose of the placebo (equivalent to ten capsules) was administered by the clinical anesthesiologist as a slurry through the oral gastric tube that was placed after induction of general anesthesia.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-21 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
22-59 years
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Age, Customized
>60 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 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
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
28 participants
n=7 Participants
|
57 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: End of surgery, and 1 hour after surgeryNRS range is 0-10 where 0 is no pain and 10 is the worst pain imaginable
Outcome measures
| Measure |
Choline
n=29 Participants
Participants ingested ten tablets (GNC Triple Lecithin 1200 choline tablets) containing 12 g of high choline lecithin and 4.2 g phosphatidyl choline the night before surgery. On the day of surgery, a second dose of study drug (equivalent to ten tablets) was administered by the clinical anesthesiologist as a slurry through the oral gastric tube that was placed after induction of general anesthesia.
|
Placebo
n=28 Participants
Participants ingested ten gelatin capsules the night before surgery. On the day of surgery, a second dose of the placebo (equivalent to ten capsules) was administered by the clinical anesthesiologist as a slurry through the oral gastric tube that was placed after induction of general anesthesia.
|
|---|---|---|
|
Numerical Rating Scale (NRS) Pain Score
End of surgery
|
5.8 score on a scale
Standard Deviation 2.2
|
7.4 score on a scale
Standard Deviation 1.7
|
|
Numerical Rating Scale (NRS) Pain Score
1 hour after surgery
|
7.4 score on a scale
Standard Deviation 5.2
|
8.8 score on a scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: 1 hour after surgery, and 24 hours after surgeryOutcome measures
| Measure |
Choline
n=29 Participants
Participants ingested ten tablets (GNC Triple Lecithin 1200 choline tablets) containing 12 g of high choline lecithin and 4.2 g phosphatidyl choline the night before surgery. On the day of surgery, a second dose of study drug (equivalent to ten tablets) was administered by the clinical anesthesiologist as a slurry through the oral gastric tube that was placed after induction of general anesthesia.
|
Placebo
n=28 Participants
Participants ingested ten gelatin capsules the night before surgery. On the day of surgery, a second dose of the placebo (equivalent to ten capsules) was administered by the clinical anesthesiologist as a slurry through the oral gastric tube that was placed after induction of general anesthesia.
|
|---|---|---|
|
Amount of Morphine Used by Participants Post-surgery
1 hour after surgery
|
3.6 mg
Interval 1.0 to 6.0
|
4 mg
Interval 1.0 to 8.0
|
|
Amount of Morphine Used by Participants Post-surgery
24 hours after surgery
|
49 mg
Interval 31.0 to 71.0
|
48 mg
Interval 33.0 to 62.0
|
Adverse Events
Choline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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