Trial Outcomes & Findings for Does Duloxetine Reduce Sub-Acute Pain After Knee Arthroplasty? (NCT NCT02005601)
NCT ID: NCT02005601
Last Updated: 2017-08-29
Results Overview
When considering the pain in the knee in which you are having/had surgery, on a scale of 0-10, with 0 being no pain and 10 being pain as bad as you can imagine, how would you describe your level of pain in the last 24 hours during ambulation?
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
106 participants
Primary outcome timeframe
2 weeks after surgery
Results posted on
2017-08-29
Participant Flow
Participant milestones
| Measure |
Duloxetine
Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken preoperatively. Starting on postoperative day (POD) 1, patients will take one capsule once a day until end of POD14.
Duloxetine 60mg: Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14.
|
Control
Patients will receive 0mg of duloxetine
Placebo: Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14.
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
53
|
|
Overall Study
COMPLETED
|
53
|
53
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Does Duloxetine Reduce Sub-Acute Pain After Knee Arthroplasty?
Baseline characteristics by cohort
| Measure |
Duloxetine
n=53 Participants
Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken preoperatively. Starting on postoperative day (POD) 1, patients will take one capsule once a day until end of POD14.
Duloxetine 60mg: Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14.
|
Control
n=53 Participants
Patients will receive 0mg of duloxetine
Placebo: Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14.
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 years
n=5 Participants
|
63 years
n=7 Participants
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 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
|
0 Participants
n=7 Participants
|
1 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
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
96 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
53 participants
n=5 Participants
|
53 participants
n=7 Participants
|
106 participants
n=5 Participants
|
|
Body Mass Index
|
31 kg/m^2
n=5 Participants
|
31 kg/m^2
n=7 Participants
|
31 kg/m^2
n=5 Participants
|
|
Knee pain severity with ambulation
|
5.8 Units on a scale
STANDARD_DEVIATION 2.5 • n=5 Participants
|
5.2 Units on a scale
STANDARD_DEVIATION 2.6 • n=7 Participants
|
5.5 Units on a scale
STANDARD_DEVIATION 2.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeks after surgeryWhen considering the pain in the knee in which you are having/had surgery, on a scale of 0-10, with 0 being no pain and 10 being pain as bad as you can imagine, how would you describe your level of pain in the last 24 hours during ambulation?
Outcome measures
| Measure |
Duloxetine
n=53 Participants
Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken preoperatively. Starting on postoperative day (POD) 1, patients will take one capsule once a day until end of POD14.
Duloxetine 60mg: Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14.
|
Control
n=53 Participants
Patients will receive 0mg of duloxetine
Placebo: Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14.
|
|---|---|---|
|
NRS Pain With Ambulation at 2 Weeks
|
3.5 NRS pain score
Standard Deviation 2.1
|
3.8 NRS pain score
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: POD 1Total daily opioid use (including PO, PCEA, IV, subcutaneous, IV push) in mg oral morphine equivalents on POD 1.
Outcome measures
| Measure |
Duloxetine
n=53 Participants
Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken preoperatively. Starting on postoperative day (POD) 1, patients will take one capsule once a day until end of POD14.
Duloxetine 60mg: Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14.
|
Control
n=53 Participants
Patients will receive 0mg of duloxetine
Placebo: Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14.
|
|---|---|---|
|
Total Daily Opioid Use (mg Oral Morphine Equivalents)
|
57.8 mg oral morphine equivalents
Standard Deviation 28.4
|
72.7 mg oral morphine equivalents
Standard Deviation 34.9
|
SECONDARY outcome
Timeframe: POD 1Nausea severity measured using Likert scale ranging from 0 (none) to 10 (severe).
Outcome measures
| Measure |
Duloxetine
n=53 Participants
Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken preoperatively. Starting on postoperative day (POD) 1, patients will take one capsule once a day until end of POD14.
Duloxetine 60mg: Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14.
|
Control
n=53 Participants
Patients will receive 0mg of duloxetine
Placebo: Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14.
|
|---|---|---|
|
Nausea Severity
|
0.9 units on a scale
Standard Deviation 2.2
|
2.3 units on a scale
Standard Deviation 3.4
|
Adverse Events
Duloxetine
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Duloxetine
n=53 participants at risk
Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken preoperatively. Starting on postoperative day (POD) 1, patients will take one capsule once a day until end of POD14.
Duloxetine 60mg: Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14.
|
Control
n=53 participants at risk
Patients will receive 0mg of duloxetine
Placebo: Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/53 • 3 months
|
1.9%
1/53 • Number of events 1 • 3 months
|
|
General disorders
Nausea
|
3.8%
2/53 • Number of events 2 • 3 months
|
1.9%
1/53 • Number of events 1 • 3 months
|
|
General disorders
Headache
|
0.00%
0/53 • 3 months
|
1.9%
1/53 • Number of events 1 • 3 months
|
|
General disorders
Somnolence
|
1.9%
1/53 • Number of events 1 • 3 months
|
0.00%
0/53 • 3 months
|
|
Endocrine disorders
SIADH
|
1.9%
1/53 • Number of events 1 • 3 months
|
0.00%
0/53 • 3 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/53 • 3 months
|
0.00%
0/53 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place