Clinical trial NCT04639011: Duloxetine Tibial Plateau
Official title: Effects of Duloxetine on Postoperative Pain Control and Knee Rehabilitation After Open Reduction Internal Fixation of Tibial Plateau Fractures
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Tibial Plateau Fracture
Pain, Postoperative
Keywords: Duloxetine
VAS pain scores
Patient Controlled Analgesia (PCA)
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if Duloxetine provides effective pain management for adult patients (18 or older) undergoing tibial plateau surgery. Participants from two institutions will be randomized to one of two treatment groups: control (Group A) and treatment (Group B). Group A control group will receive placebo of sugar pill and BMC standard of care - namely postoperative, IV administration of opioids via a patient controlled analgesia (PCA) system which utilizes a hydromorphone pump (BMC standard of care). Group B, the intervention group, will receive three doses of 60 mg of oral duloxetine (right before operation, postop day 1, postop day 2).

This study is important as tibial plateau surgery's postoperative pain management primarily involved providing opioids, and if duloxetine can result in reduced narcotic intake and lower pain scores, it can potentially improve patient care, rehabilitation, early movement, and shorter length of hospital stay.


Eligibility criteria: Inclusion Criteria:

* Tibial plateau fracture that requires operative fixation
* Ambulatory patient prior to fracture

Exclusion Criteria:

* Previous tibial plateau fracture on ipsilateral knee
* History of Complex Regional Pain Syndrome in ipsilateral extremity
* History of any demyelinating disorder or neurologic deficit that may contribute to altered pain tolerance/sensation
* Acute or chronic knee infection in ipsilateral extremity
* Previous total knee arthroplasty or knee hemiarthroplasty in ipsilateral knee
* Allergy to morphine (used in the SOC PCA pump)
* Pregnant or breastfeeding as determined by standard of care pre-operative urine pregnancy test
* Polytrauma
* Open fracture
* IV drug user
* Rheumatoid arthritis
* Revision cases
* Non-ambulatory
* Anatomical deformities of the knee
* Hepatic dysfunction or cirrhosis
* Taking Selective Serotonin Reuptake Inhibitor (SSRI), serotonin-norepinephrine reuptake Inhibitor (SNRI), monoamine oxidase inhibitors (MAOIs), tri- or tetra- cyclic anti-depressant
* Renal impairment (mention in patient chart and/or creatinine clearance \<30)
* Moderate to severe depression
* Taking CYP1A2 inhibitors and CYP1A6 inhibitors

Primary outcomes:
measure: Pain levels in the first 16 hours after surgery
timeFrame: every 4 hours up to 16 hours
measure: Pain level 24 hours after surgery
timeFrame: 24 hours
measure: Pain level 36 hours after surgery
timeFrame: 36 hours
Secondary outcomes:
measure: Total morphine consumption
timeFrame: up to 10 days post op
measure: Change in knee range of motion
timeFrame: 6 weeks, 12 weeks
measure: Self reported functional status at 6 weeks
timeFrame: 6 weeks
measure: Self reported functional status at 12 weeks
timeFrame: 12 weeks
measure: Hospital length of stay
timeFrame: 12 weeks
measure: Time to mobilization (starting to walk)
timeFrame: 12 weeks
measure: Ambulation (walking) distance on post-op days 1 or 2
timeFrame: Up to 2 days post op
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Valhalla
country: United States
facility: Westchester Medical Center
state: New York
Study officials:
affiliation: Boston Medical Center
name: Seroos Salavati, MD
role: PRINCIPAL_INVESTIGATOR
References: