Trial Outcomes & Findings for Effect of Duloxetine on Opioid Use After Total Knee Arthroplasty (NCT NCT03271151)
NCT ID: NCT03271151
Last Updated: 2024-12-27
Results Overview
Opioid use (measured in cumulative morphine equivalents)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
160 participants
Primary outcome timeframe
Post-operative day 14
Results posted on
2024-12-27
Participant Flow
Participant milestones
| Measure |
Duloxetine ("Cymbalta")
Epidural analgesia after knee arthroplasty is not as prevalent at HSS as formerly, in large part due to the rise of local infiltration analgesia. Studies using epidural analgesia may also lack generalizability given the infrequent use of epidural analgesia at other institutions. For these reasons, we plan to use adductor canal nerve blockade + local infiltration analgesia for management of immediate postoperative pain. Patients will receive spinal anesthesia as the primary anesthetic. It is particularly important to study duloxetine ("Cymbalta") in the context of local infiltration analgesia, as patients receiving local infiltration analgesia receive increased doses of opioids, compared to patients receiving epidural analgesia.
Cymbalta: Duloxetine ("Cymbalta") is a serotonin and norepinephrine dual reuptake inhibitor (SNRI) that is an effective treatment for painful diabetic neuropathy. It is approved for major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathy, fibromyalgia, and chronic musculoskeletal pain
|
Placebo
Placebo to compare pain scores and opioid use againts Duloxetine
Placebo: Placebo to compare outcomes against Duloxetine
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
80
|
|
Overall Study
COMPLETED
|
78
|
77
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Duloxetine ("Cymbalta")
Epidural analgesia after knee arthroplasty is not as prevalent at HSS as formerly, in large part due to the rise of local infiltration analgesia. Studies using epidural analgesia may also lack generalizability given the infrequent use of epidural analgesia at other institutions. For these reasons, we plan to use adductor canal nerve blockade + local infiltration analgesia for management of immediate postoperative pain. Patients will receive spinal anesthesia as the primary anesthetic. It is particularly important to study duloxetine ("Cymbalta") in the context of local infiltration analgesia, as patients receiving local infiltration analgesia receive increased doses of opioids, compared to patients receiving epidural analgesia.
Cymbalta: Duloxetine ("Cymbalta") is a serotonin and norepinephrine dual reuptake inhibitor (SNRI) that is an effective treatment for painful diabetic neuropathy. It is approved for major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathy, fibromyalgia, and chronic musculoskeletal pain
|
Placebo
Placebo to compare pain scores and opioid use againts Duloxetine
Placebo: Placebo to compare outcomes against Duloxetine
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Effect of Duloxetine on Opioid Use After Total Knee Arthroplasty
Baseline characteristics by cohort
| Measure |
Duloxetine ("Cymbalta")
n=80 Participants
Epidural analgesia after knee arthroplasty is not as prevalent at HSS as formerly, in large part due to the rise of local infiltration analgesia. Studies using epidural analgesia may also lack generalizability given the infrequent use of epidural analgesia at other institutions. For these reasons, we plan to use adductor canal nerve blockade + local infiltration analgesia for management of immediate postoperative pain. Patients will receive spinal anesthesia as the primary anesthetic. It is particularly important to study duloxetine ("Cymbalta") in the context of local infiltration analgesia, as patients receiving local infiltration analgesia receive increased doses of opioids, compared to patients receiving epidural analgesia.
Cymbalta: Duloxetine ("Cymbalta") is a serotonin and norepinephrine dual reuptake inhibitor (SNRI) that is an effective treatment for painful diabetic neuropathy. It is approved for major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathy, fibromyalgia, and chronic musculoskeletal pain
|
Placebo
n=80 Participants
Placebo to compare pain scores and opioid use againts Duloxetine
Placebo: Placebo to compare outcomes against Duloxetine
|
Total
n=160 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
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
39 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 11 • n=5 Participants
|
64 years
STANDARD_DEVIATION 7 • n=7 Participants
|
63 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
76 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
154 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
|
PRIMARY outcome
Timeframe: Post-operative day 14Opioid use (measured in cumulative morphine equivalents)
Outcome measures
| Measure |
Duloxetine ("Cymbalta")
n=78 Participants
Epidural analgesia after knee arthroplasty is not as prevalent at HSS as formerly, in large part due to the rise of local infiltration analgesia. Studies using epidural analgesia may also lack generalizability given the infrequent use of epidural analgesia at other institutions. For these reasons, we plan to use adductor canal nerve blockade + local infiltration analgesia for management of immediate postoperative pain. Patients will receive spinal anesthesia as the primary anesthetic. It is particularly important to study duloxetine ("Cymbalta") in the context of local infiltration analgesia, as patients receiving local infiltration analgesia receive increased doses of opioids, compared to patients receiving epidural analgesia.
Cymbalta: Duloxetine ("Cymbalta") is a serotonin and norepinephrine dual reuptake inhibitor (SNRI) that is an effective treatment for painful diabetic neuropathy. It is approved for major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathy, fibromyalgia, and chronic musculoskeletal pain
|
Placebo
n=77 Participants
Placebo to compare pain scores and opioid use againts Duloxetine
Placebo: Placebo to compare outcomes against Duloxetine
|
|---|---|---|
|
Opioid Use
|
288 Oral Morphine Equivalent (mg)
Standard Deviation 226
|
432.5 Oral Morphine Equivalent (mg)
Standard Deviation 374
|
PRIMARY outcome
Timeframe: Post-operative day 14Numerical Rating Score pain with movement. Minimum value of 0, maximum value of 10. Higher scores mean more pain and worse outcome.
Outcome measures
| Measure |
Duloxetine ("Cymbalta")
n=78 Participants
Epidural analgesia after knee arthroplasty is not as prevalent at HSS as formerly, in large part due to the rise of local infiltration analgesia. Studies using epidural analgesia may also lack generalizability given the infrequent use of epidural analgesia at other institutions. For these reasons, we plan to use adductor canal nerve blockade + local infiltration analgesia for management of immediate postoperative pain. Patients will receive spinal anesthesia as the primary anesthetic. It is particularly important to study duloxetine ("Cymbalta") in the context of local infiltration analgesia, as patients receiving local infiltration analgesia receive increased doses of opioids, compared to patients receiving epidural analgesia.
Cymbalta: Duloxetine ("Cymbalta") is a serotonin and norepinephrine dual reuptake inhibitor (SNRI) that is an effective treatment for painful diabetic neuropathy. It is approved for major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathy, fibromyalgia, and chronic musculoskeletal pain
|
Placebo
n=77 Participants
Placebo to compare pain scores and opioid use againts Duloxetine
Placebo: Placebo to compare outcomes against Duloxetine
|
|---|---|---|
|
Pain Scores
|
4.2 score on a scale (NRS)
Standard Deviation 2
|
4.8 score on a scale (NRS)
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Day of surgery2011 Survey Criteria for Fibromyalgia. Minimum value of 0, and maximum value of 12. A higher score means a worse outcome.
Outcome measures
| Measure |
Duloxetine ("Cymbalta")
n=80 Participants
Epidural analgesia after knee arthroplasty is not as prevalent at HSS as formerly, in large part due to the rise of local infiltration analgesia. Studies using epidural analgesia may also lack generalizability given the infrequent use of epidural analgesia at other institutions. For these reasons, we plan to use adductor canal nerve blockade + local infiltration analgesia for management of immediate postoperative pain. Patients will receive spinal anesthesia as the primary anesthetic. It is particularly important to study duloxetine ("Cymbalta") in the context of local infiltration analgesia, as patients receiving local infiltration analgesia receive increased doses of opioids, compared to patients receiving epidural analgesia.
Cymbalta: Duloxetine ("Cymbalta") is a serotonin and norepinephrine dual reuptake inhibitor (SNRI) that is an effective treatment for painful diabetic neuropathy. It is approved for major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathy, fibromyalgia, and chronic musculoskeletal pain
|
Placebo
n=80 Participants
Placebo to compare pain scores and opioid use againts Duloxetine
Placebo: Placebo to compare outcomes against Duloxetine
|
|---|---|---|
|
Pain Phenotype
|
2 score on a scale
Interval 1.0 to 4.0
|
2 score on a scale
Interval 1.0 to 4.0
|
Adverse Events
Duloxetine ("Cymbalta")
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
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 ("Cymbalta")
n=80 participants at risk
Epidural analgesia after knee arthroplasty is not as prevalent at HSS as formerly, in large part due to the rise of local infiltration analgesia. Studies using epidural analgesia may also lack generalizability given the infrequent use of epidural analgesia at other institutions. For these reasons, we plan to use adductor canal nerve blockade + local infiltration analgesia for management of immediate postoperative pain. Patients will receive spinal anesthesia as the primary anesthetic. It is particularly important to study duloxetine ("Cymbalta") in the context of local infiltration analgesia, as patients receiving local infiltration analgesia receive increased doses of opioids, compared to patients receiving epidural analgesia.
Cymbalta: Duloxetine ("Cymbalta") is a serotonin and norepinephrine dual reuptake inhibitor (SNRI) that is an effective treatment for painful diabetic neuropathy. It is approved for major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathy, fibromyalgia, and chronic musculoskeletal pain
|
Placebo
n=80 participants at risk
Placebo to compare pain scores and opioid use againts Duloxetine
Placebo: Placebo to compare outcomes against Duloxetine
|
|---|---|---|
|
General disorders
Hallucinations
|
1.2%
1/80 • Number of events 1 • 3 months
|
1.2%
1/80 • Number of events 1 • 3 months
|
|
Reproductive system and breast disorders
Unable to Ejaculate
|
1.2%
1/80 • Number of events 1 • 3 months
|
0.00%
0/80 • 3 months
|
|
General disorders
Increased diaphoresis, blood pressure, complaints of diarrhea decreased unration and tooth pain
|
0.00%
0/80 • 3 months
|
1.2%
1/80 • Number of events 1 • 3 months
|
|
General disorders
Acne
|
0.00%
0/80 • 3 months
|
1.2%
1/80 • Number of events 1 • 3 months
|
Additional Information
Dr. Jacques Yadeau
Anesthesiology Critical Care & Pain Management
Phone: 2127742224
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place