WithdrawnPhase 4

Duloxetine Tibial Plateau

Stopped: Study was not conducted because funding was not obtained.

United States0Started 2022-10

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Pain levels in the first 16 hours after surgery

Timeframe: every 4 hours up to 16 hours

Pain level 24 hours after surgery

Timeframe: 24 hours

Pain level 36 hours after surgery

Timeframe: 36 hours

Trial details

NCT IDNCT04639011

SponsorBoston Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12