Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Does Duloxetine Reduce Sub-Acute Pain After Knee Arthroplasty?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02005601
Recruitment Status : Completed
First Posted : December 9, 2013
Results First Posted : August 29, 2017
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Total Knee Arthroplasty
Interventions Drug: Placebo
Drug: Duloxetine 60mg
Enrollment 106
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Duloxetine Control
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 53 53
Completed 53 53
Not Completed 0 0
Arm/Group Title Duloxetine Control Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 53 53 106
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 53 participants 53 participants 106 participants
67
(61 to 71)
63
(57 to 67)
64
(59 to 70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 53 participants 106 participants
Female
28
  52.8%
26
  49.1%
54
  50.9%
Male
25
  47.2%
27
  50.9%
52
  49.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 53 participants 106 participants
Hispanic or Latino
3
   5.7%
3
   5.7%
6
   5.7%
Not Hispanic or Latino
50
  94.3%
46
  86.8%
96
  90.6%
Unknown or Not Reported
0
   0.0%
4
   7.5%
4
   3.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 53 participants 106 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   1.9%
0
   0.0%
1
   0.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   3.8%
4
   7.5%
6
   5.7%
White
48
  90.6%
48
  90.6%
96
  90.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   3.8%
1
   1.9%
3
   2.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 53 participants 53 participants 106 participants
53 53 106
Body Mass Index  
Median (Inter-Quartile Range)
Unit of measure:  Kg/m^2
Number Analyzed 53 participants 53 participants 106 participants
31
(27 to 36)
31
(27 to 35)
31
(27 to 35)
Knee pain severity with ambulation   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 53 participants 53 participants 106 participants
5.8  (2.5) 5.2  (2.6) 5.5  (2.6)
[1]
Measure Description: Knee pain severity assessed on Numeric Pain Rating scale, which range from 0 (no pain) to 10 (worst pain)
1.Primary Outcome
Title NRS Pain With Ambulation at 2 Weeks
Hide Description 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?
Time Frame 2 weeks after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duloxetine Control
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 53 53
Mean (Standard Deviation)
Unit of Measure: NRS pain score
3.5  (2.1) 3.8  (2.3)
2.Secondary Outcome
Title Total Daily Opioid Use (mg Oral Morphine Equivalents)
Hide Description Total daily opioid use (including PO, PCEA, IV, subcutaneous, IV push) in mg oral morphine equivalents on POD 1.
Time Frame POD 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duloxetine Control
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 53 53
Mean (Standard Deviation)
Unit of Measure: mg oral morphine equivalents
57.8  (28.4) 72.7  (34.9)
3.Secondary Outcome
Title Nausea Severity
Hide Description Nausea severity measured using Likert scale ranging from 0 (none) to 10 (severe).
Time Frame POD 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duloxetine Control
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 53 53
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.9  (2.2) 2.3  (3.4)
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Duloxetine Control
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Duloxetine Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/53 (0.00%)      0/53 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Duloxetine Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/53 (0.00%)      0/53 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Duloxetine Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/53 (7.55%)      3/53 (5.66%)    
Cardiac disorders     
Atrial fibrillation * 1  0/53 (0.00%)  0 1/53 (1.89%)  1
Endocrine disorders     
SIADH * 1  1/53 (1.89%)  1 0/53 (0.00%)  0
General disorders     
Nausea * 1  2/53 (3.77%)  2 1/53 (1.89%)  1
Headache * 1  0/53 (0.00%)  0 1/53 (1.89%)  1
Somnolence * 1  1/53 (1.89%)  1 0/53 (0.00%)  0
Psychiatric disorders     
Insomnia * 1  0/53 (0.00%)  0 0/53 (0.00%)  0
1
Term from vocabulary, Other
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jacques Yadeau
Organization: Hospital for Special Surgery
Phone: 212-606-1206
EMail: yadeauj@hss.edu
Layout table for additonal information
Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT02005601     History of Changes
Other Study ID Numbers: 2012-016
First Submitted: December 4, 2013
First Posted: December 9, 2013
Results First Submitted: March 15, 2017
Results First Posted: August 29, 2017
Last Update Posted: August 29, 2017