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Does Duloxetine Reduce Sub-Acute Pain After Knee Arthroplasty?

Primary Purpose

Total Knee Arthroplasty

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Placebo
Duloxetine 60mg
Sponsored by
Hospital for Special Surgery, New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Total Knee Arthroplasty

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital for Special Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Duloxetine

Control

Arm 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.

Patients will receive 0mg of duloxetine

Outcomes

Primary Outcome Measures

NRS Pain With Ambulation at 2 Weeks
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?

Secondary Outcome Measures

Total Daily Opioid Use (mg Oral Morphine Equivalents)
Total daily opioid use (including PO, PCEA, IV, subcutaneous, IV push) in mg oral morphine equivalents on POD 1.
Nausea Severity
Nausea severity measured using Likert scale ranging from 0 (none) to 10 (severe).

Full Information

First Posted
December 4, 2013
Last Updated
July 27, 2017
Sponsor
Hospital for Special Surgery, New York
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1. Study Identification

Unique Protocol Identification Number
NCT02005601
Brief Title
Does Duloxetine Reduce Sub-Acute Pain After Knee Arthroplasty?
Official Title
Does Duloxetine Reduce Sub-Acute Pain After Knee Arthroplasty?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Knee Arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Duloxetine
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Patients will receive 0mg of duloxetine
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Duloxetine 60mg
Other Intervention Name(s)
Cymbalta
Intervention Description
Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14.
Primary Outcome Measure Information:
Title
NRS Pain With Ambulation at 2 Weeks
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
Secondary Outcome Measure Information:
Title
Total Daily Opioid Use (mg Oral Morphine Equivalents)
Description
Total daily opioid use (including PO, PCEA, IV, subcutaneous, IV push) in mg oral morphine equivalents on POD 1.
Time Frame
POD 1
Title
Nausea Severity
Description
Nausea severity measured using Likert scale ranging from 0 (none) to 10 (severe).
Time Frame
POD 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques T YaDeau, MD, PhD
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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Does Duloxetine Reduce Sub-Acute Pain After Knee Arthroplasty?

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