Duloxetine Tibial Plateau

Boston Medical Center (BMC)

Status and phase: Withdrawn; Phase 4

Conditions: Tibial Plateau Fracture; Pain, Postoperative

Treatments: Drug: Duloxetine; Other: Placebo; Other: Standard of care (SOC) for tibial plateau surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04639011

H-40569

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

Group A Placebo

Active Comparator group

Description:

Participants randomized to Group A will receive placebo (sugar pill) and Boston Medical Center (BMC) standard of care.

Treatment:

Other: Standard of care (SOC) for tibial plateau surgery

Other: Placebo

Groups B Intervention

Experimental group

Description:

Participants randomized to Group B will receive duloxetine and Boston Medical Center (BMC) standard of care.

Treatment:

Other: Standard of care (SOC) for tibial plateau surgery

Drug: Duloxetine