Clinical trial NCT03271151: Effect of Duloxetine on Opioid Use After Total Knee Arthroplasty
Official title: Effect of Duloxetine on Opioid Use After Total Knee Arthroplasty: A Double-blinded Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Joint Disease
Pain, Acute
Pain, Chronic
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 160
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Post-discharge pain after total knee arthroplasty remains problematic; many patients have excessive pain at the 2 week time point (and often thereafter). Reduction in opioid use has become a national goal, due to the 'epidemic' in opioid misuse.

In addition to enrolling non-opioid users, we will enroll up to 15 chronic opioid users.


Eligibility criteria: Inclusion Criteria:

* 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:

* Current Use of duloxetine or other SNRIs, SSRIs, MAOIs, Tricyclic antidepressants, triptans (sumatriptan, rizatriptan, naratriptan, eletriptan, almotriptan, frovatriptan), lithium, buspirone, St. John's Wort
* Hepatic insufficiency

  o Hepatoxicity is reported as a side effect of duloxetine. "Median time to detection of transaminase elevation was about two months" (package insert 5.2
* Renal insufficiency (ESRD, HD, estimated creatinine clearance \< 50 ml/min)

  * Severe CRI may impair duloxetine clearance
  * CLcr=\[(140-age (years)\] x weight (kg)x0.85 (for female patients)/\[72xserum creatinine (mg/dL)\]
* 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)
* Patients with major prior ipsilateral open knee surgery.
* Chronic opioid use (taking opioids for longer than 3 months)

  * However, patients using chronic opioids may enroll in a parallel pilot study entitled 'effect of duloxetine on opioid use after total knee athroplasty among patients exposed to opioids- a pilot study'. The chronic opioid users will be allowed to continue their customary analgesics. The pilot study is otherwise identical to the main study.
  * This study will enroll up to 15 chronic opioid users. After that, all chronic opioid users are excluded.

Primary outcomes:
measure: Opioid Use
timeFrame: Post-operative day 14
measure: Pain Scores
timeFrame: Post-operative day 14
Secondary outcomes:
measure: Pain Phenotype
timeFrame: Day of surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Jacques T YaDeau, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References: