Does Duloxetine Reduce Sub-Acute Pain After Knee Arthroplasty?
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|ClinicalTrials.gov Identifier: NCT02005601|
Recruitment Status : Completed
First Posted : December 9, 2013
Results First Posted : August 29, 2017
Last Update Posted : August 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Total Knee Arthroplasty||Drug: Placebo Drug: Duloxetine 60mg||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Does Duloxetine Reduce Sub-Acute Pain After Knee Arthroplasty?|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||August 2015|
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.
Drug: 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.
Other Name: Cymbalta
Placebo Comparator: Control
Patients will receive 0mg of duloxetine
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 [ Time Frame: 2 weeks after surgery ]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?
- Total Daily Opioid Use (mg Oral Morphine Equivalents) [ Time Frame: POD 1 ]Total daily opioid use (including PO, PCEA, IV, subcutaneous, IV push) in mg oral morphine equivalents on POD 1.
- Nausea Severity [ Time Frame: POD 1 ]Nausea severity measured using Likert scale ranging from 0 (none) to 10 (severe).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005601
|United States, New York|
|Hospital for Special Surgery|
|New York, New York, United States, 10021|
|Principal Investigator:||Jacques T YaDeau, MD, PhD||Hospital for Special Surgery, New York|