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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
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Tracking Information
First Submitted Date  ICMJE December 4, 2013
First Posted Date  ICMJE December 9, 2013
Results First Submitted Date  ICMJE March 15, 2017
Results First Posted Date  ICMJE August 29, 2017
Last Update Posted Date August 29, 2017
Study Start Date  ICMJE November 2013
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2013)
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?
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02005601 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2017)
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2013)
Numeric Rating Scale (NRS) Pain Scores at Rest, during Ambulation and while Bending Knee [ Time Frame: Preoperative, postoperative day (POD) 1, POD 3, POD 14, POD 18-20, 6 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 at rest? during ambulation? while bending your knee?
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Does Duloxetine Reduce Sub-Acute Pain After Knee Arthroplasty?
Official Title  ICMJE Does Duloxetine Reduce Sub-Acute Pain After Knee Arthroplasty?
Brief Summary We are investigating the impact of duloxetine ("Cymbalta"), a serotonin and norepinephrine reuptake inhibitor, on pain after total knee arthroplasty (TKA). Specifically, the investigators will determine whether duloxetine, 60 mg daily for 2 weeks, reduces pain scores 2 weeks after TKA.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Total Knee Arthroplasty
Intervention  ICMJE
  • Drug: 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.
  • 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
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Drug: Duloxetine 60mg
  • Placebo Comparator: Control
    Patients will receive 0mg of duloxetine
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 17, 2013)
106
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with osteoarthritis scheduled for primary tricompartmental total knee arthroplasty with a participating surgeon
  • Age 25 to 75 years
  • Planned use of regional anesthesia
  • Ability to follow study protocol
  • English speaking (primary outcome obtained via telephone call and secondary outcomes include questionnaires validated in English only)
  • Patients planning on being discharged home or to a rehabilitation center that has agreed to participate

Exclusion Criteria:

  • Concurrent use of duloxetine or other SNRIs, MAOIs, Tricyclic antidepressants, triptans (sumatriptan, rizatriptan, naratriptan, zolmitriptan, eletriptan, almotriptan, frovatriptan), lithium, buspirone, St. John's Wort
  • Hepatic insufficiency
  • Renal insufficiency
  • Patients younger than 25 years old and older than 75
  • Patients intending to receive general anesthesia
  • Allergy or intolerance to one of the study medications
  • Patients with an ASA of IV
  • Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
  • Chronic opioid use (taking opioids for longer than 3 months)
  • Patients with major prior ipsilateral open knee surgery
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02005601
Other Study ID Numbers  ICMJE 2012-016
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospital for Special Surgery, New York
Study Sponsor  ICMJE Hospital for Special Surgery, New York
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jacques T YaDeau, MD, PhD Hospital for Special Surgery, New York
PRS Account Hospital for Special Surgery, New York
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP