Trial Outcomes & Findings for Duloxetine as an Analgesic Agent in Patients Undergoing Elective Spine Surgery (NCT NCT02535000)
NCT ID: NCT02535000
Last Updated: 2020-10-09
Results Overview
The main evaluation parameter was the total consumption of fentanyl (in micrograms) self-administered by the patient and accessed at 24 and 48 hours after surgery. At the beginning of the study, Group C (placebo) would have 30 patients and D (duloxetine) would also have 30 patients. However, 1 patient in Group C and 2 patients in Group D were excluded due to the cancellation of the proposed surgery, after the patient had received 60 milligrams of duloxetine. The lower the consumption of fentanyl, the better the analgesic effect of duloxetine.
COMPLETED
PHASE4
60 participants
up to 2 days.
2020-10-09
Participant Flow
The study was started in January, 2014 at the Centro Hospitalar Unimed of Joinville, Brazil
Participant milestones
| Measure |
Group C (Control)
subjects who will receive one capsule of placebo before the surgery and being repeated the next day
Placebo: placebo
|
Group D (Duloxetine)
subjects who will receive one capsule of duloxetine 60 mg before the surgery and being repeated the next day
Duloxetine: duloxetine 60 mg
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
29
|
28
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Group C (Control)
subjects who will receive one capsule of placebo before the surgery and being repeated the next day
Placebo: placebo
|
Group D (Duloxetine)
subjects who will receive one capsule of duloxetine 60 mg before the surgery and being repeated the next day
Duloxetine: duloxetine 60 mg
|
|---|---|---|
|
Overall Study
Cancellation of surgery.
|
1
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group C (Control)
n=29 Participants
subjects who will receive one capsule of placebo before the surgery and being repeated the next day
Placebo: placebo
|
Group D (Duloxetine)
n=28 Participants
subjects who will receive one capsule of duloxetine 60 mg before the surgery and being repeated the next day
Duloxetine: duloxetine 60 mg
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=29 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=57 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=29 Participants
|
28 Participants
n=28 Participants
|
57 Participants
n=57 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=29 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=57 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=29 Participants
|
15 Participants
n=28 Participants
|
31 Participants
n=57 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=29 Participants
|
13 Participants
n=28 Participants
|
26 Participants
n=57 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Brazil
|
29 participants
n=29 Participants
|
28 participants
n=28 Participants
|
57 participants
n=57 Participants
|
PRIMARY outcome
Timeframe: up to 2 days.Population: At the beginning of the trial, Group C would have 30 patients and D also 30 patients. However, 1 patient in Group C and 2 patients in group D were excluded due to cancellation of the proposed surgery, after patient receiving 60 mg of duloxetine. The lower the consumption of fentanyl, the better the analgesic effect of duloxetine.
The main evaluation parameter was the total consumption of fentanyl (in micrograms) self-administered by the patient and accessed at 24 and 48 hours after surgery. At the beginning of the study, Group C (placebo) would have 30 patients and D (duloxetine) would also have 30 patients. However, 1 patient in Group C and 2 patients in Group D were excluded due to the cancellation of the proposed surgery, after the patient had received 60 milligrams of duloxetine. The lower the consumption of fentanyl, the better the analgesic effect of duloxetine.
Outcome measures
| Measure |
Group C (Control)
n=29 Participants
subjects who will receive one capsule of placebo before the surgery and being repeated the next day
Placebo: placebo
|
Group D (Duloxetine)
n=28 Participants
subjects who will receive one capsule of duloxetine 60 mg before the surgery and being repeated the next day
Duloxetine: duloxetine 60 mg
|
|---|---|---|
|
Total Consumption of Fentanyl (in Micrograms) Self-administered by the Patient and Accessed at 24 and 48 Hours After Spine Surgery.
Fentanyl consumption in between 0 and 24 hours.
|
726 micrograms
Standard Deviation 36
|
503 micrograms
Standard Deviation 19
|
|
Total Consumption of Fentanyl (in Micrograms) Self-administered by the Patient and Accessed at 24 and 48 Hours After Spine Surgery.
Fentanyl consumption in between 24 and 48 hours.
|
180 micrograms
Standard Deviation 20
|
136 micrograms
Standard Deviation 13
|
SECONDARY outcome
Timeframe: up to 2 days.Population: At the beginning of the study, Group C (placebo) would have 30 patients and D (duloxetine) would also have 30 patients. However, 1 patient in Group C and 2 patients in Group D were excluded due to the cancellation of the proposed surgery, after the patient had received 60 milligrams of duloxetine.
At the beginning of the study, Group C (placebo) would have 30 patients and D (duloxetine) would also have 30 patients. However, 1 patient in Group C and 2 patients in Group D were excluded due to the cancellation of the proposed surgery, after the patient had received 60 milligrams of duloxetine. Self reported pain score range from 0 (no pain) to 10 (worst possible pain) 2, 6, 12, 24, 36 and 48 hours after surgery. Higher scores mean a worse score and low scores mean a better score.
Outcome measures
| Measure |
Group C (Control)
n=29 Participants
subjects who will receive one capsule of placebo before the surgery and being repeated the next day
Placebo: placebo
|
Group D (Duloxetine)
n=28 Participants
subjects who will receive one capsule of duloxetine 60 mg before the surgery and being repeated the next day
Duloxetine: duloxetine 60 mg
|
|---|---|---|
|
Self Reported Pain Score Range From 0 (no Pain) to 10 (Worst Possible Pain).
Pain score 2 hours after surgery.
|
2.27 Number (pain score range 0 to 10).
Standard Deviation 2.67
|
2.14 Number (pain score range 0 to 10).
Standard Deviation 2.04
|
|
Self Reported Pain Score Range From 0 (no Pain) to 10 (Worst Possible Pain).
pain score 6 hours after surgery
|
2.67 Number (pain score range 0 to 10).
Standard Deviation 2.44
|
2.28 Number (pain score range 0 to 10).
Standard Deviation 2.07
|
|
Self Reported Pain Score Range From 0 (no Pain) to 10 (Worst Possible Pain).
Pain score 12 hours after surgery.
|
2.10 Number (pain score range 0 to 10).
Standard Deviation 2.31
|
2.07 Number (pain score range 0 to 10).
Standard Deviation 1.92
|
|
Self Reported Pain Score Range From 0 (no Pain) to 10 (Worst Possible Pain).
Pain score 24 hours after surgery.
|
1.68 Number (pain score range 0 to 10).
Standard Deviation 2.13
|
1.66 Number (pain score range 0 to 10).
Standard Deviation 1.64
|
|
Self Reported Pain Score Range From 0 (no Pain) to 10 (Worst Possible Pain).
Pain score 36 hours after surgery.
|
1.48 Number (pain score range 0 to 10).
Standard Deviation 2.06
|
1.37 Number (pain score range 0 to 10).
Standard Deviation 1.52
|
|
Self Reported Pain Score Range From 0 (no Pain) to 10 (Worst Possible Pain).
Pain score 48 hours after surgery.
|
1.51 Number (pain score range 0 to 10).
Standard Deviation 2.08
|
1.07 Number (pain score range 0 to 10).
Standard Deviation 1.03
|
Adverse Events
Group C (Control)
Group D (Duloxetine)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group C (Control)
n=29 participants at risk
subjects who will receive one capsule of placebo before the surgery and being repeated the next day
Placebo: placebo
|
Group D (Duloxetine)
n=28 participants at risk
subjects who will receive one capsule of duloxetine 60 mg before the surgery and being repeated the next day
Duloxetine: duloxetine 60 mg
|
|---|---|---|
|
Nervous system disorders
somnolence
|
17.2%
5/29 • Number of events 5 • Two days.
Incidence of adverse effects accessed in the first two postoperative days.
|
14.3%
4/28 • Number of events 4 • Two days.
Incidence of adverse effects accessed in the first two postoperative days.
|
|
General disorders
itching
|
6.9%
2/29 • Number of events 2 • Two days.
Incidence of adverse effects accessed in the first two postoperative days.
|
3.6%
1/28 • Number of events 1 • Two days.
Incidence of adverse effects accessed in the first two postoperative days.
|
|
Gastrointestinal disorders
nausea
|
6.9%
2/29 • Number of events 2 • Two days.
Incidence of adverse effects accessed in the first two postoperative days.
|
10.7%
3/28 • Number of events 3 • Two days.
Incidence of adverse effects accessed in the first two postoperative days.
|
|
Nervous system disorders
Headache
|
3.4%
1/29 • Number of events 1 • Two days.
Incidence of adverse effects accessed in the first two postoperative days.
|
3.6%
1/28 • Number of events 1 • Two days.
Incidence of adverse effects accessed in the first two postoperative days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place