Duloxetine Tibial Plateau

Sponsor

Boston Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04639011

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tibial Plateau Fracture Pain, Postoperative	Drug: Duloxetine Other: Placebo Other: Standard of care (SOC) for tibial plateau surgery	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Effects of Duloxetine on Postoperative Pain Control and Knee Rehabilitation After Open Reduction Internal Fixation of Tibial Plateau Fractures

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group A Placebo Participants randomized to Group A will receive placebo (sugar pill) and Boston Medical Center (BMC) standard of care.	Other: Placebo Three doses of placebo will be given to participants (right before operation, postop day 1, postop day 2). Other Names: Sugar pill Other: Standard of care (SOC) for tibial plateau surgery Postoperative IV administration of opioids via a patient controlled analgesia (PCA) system which utilizes a hydromorphone pump.
Experimental: Groups B Intervention Participants randomized to Group B will receive duloxetine and Boston Medical Center (BMC) standard of care.	Drug: Duloxetine Three doses of 60 mg of oral duloxetine will be given to participants (right before operation, postop day 1, postop day 2) Other Names: Serotonin-norepinephrine reuptake inhibitor (SNRI) Other: Standard of care (SOC) for tibial plateau surgery Postoperative IV administration of opioids via a patient controlled analgesia (PCA) system which utilizes a hydromorphone pump.

Arm

Intervention/Treatment

Active Comparator: Group A Placebo

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

Other: Placebo

Three doses of placebo will be given to participants (right before operation, postop day 1, postop day 2).

Other Names:

Sugar pill

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

Postoperative IV administration of opioids via a patient controlled analgesia (PCA) system which utilizes a hydromorphone pump.

Experimental: Groups B Intervention

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

Drug: Duloxetine

Three doses of 60 mg of oral duloxetine will be given to participants (right before operation, postop day 1, postop day 2)

Other Names:

Serotonin-norepinephrine reuptake inhibitor (SNRI)

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

Postoperative IV administration of opioids via a patient controlled analgesia (PCA) system which utilizes a hydromorphone pump.

Outcome Measures

Primary Outcome Measures

Pain levels in the first 16 hours after surgery [every 4 hours up to 16 hours]
A visual analog pain scale (VAS) will be used to assess postoperative pain levels. Participants will make a mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." HIgher scores reflect greater pain levels.
Pain level 24 hours after surgery [24 hours]
A visual analog pain scale (VAS) will be used to assess the postoperative pain level. Participants will make a mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." HIgher scores reflect greater pain levels.
Pain level 36 hours after surgery [36 hours]
A visual analog pain scale (VAS) will be used to assess the postoperative pain level. Participants will make a mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." HIgher scores reflect greater pain levels.

Secondary Outcome Measures

Total morphine consumption [up to 10 days post op]
The total morphine consumption will be calculated using the Centers for Disease Control (CDC) morphine equivalents [ME].Determine the total daily amount of morphine taken; convert to MEs by multiplying the daily dosage for each opioid by its conversion factor [which is =1 for morphine]; then add all morphine MEs together.
Change in knee range of motion [6 weeks, 12 weeks]
The knee range of motion will be abstracted from the electronic medical record. Knee range of motion ranges from 0 to 140 degrees.
Self reported functional status at 6 weeks [6 weeks]
Functional status will be assessed using the Short Musculoskeletal Function Assessment (SMFA). SMFA is a 46 item questionnaire. It consists of the dysfunction index, which has 34 items for the assessment of patient function, and the bother index, which has 12 items for the assessment of how much patients are bothered by functional problems.
Self reported functional status at 12 weeks [12 weeks]
Functional status will be assessed using the Short Musculoskeletal Function Assessment (SMFA). SMFA is a 46 item questionnaire. It consists of the dysfunction index, which has 34 items for the assessment of patient function, and the bother index, which has 12 items for the assessment of how much patients are bothered by functional problems.
Hospital length of stay [12 weeks]
The hospital length of stay will be measured in days, calculated by subtracting the date of admission from the date of discharge as recorded in the electronic medical record.
Time to mobilization (starting to walk) [12 weeks]
The time to mobilization will be calculated by subtracting the date the participant started to walk post operatively from the date of surgery as recorded in the electronic medical record.
Ambulation (walking) distance on post-op days 1 or 2 [Up to 2 days post op]
The walking distance will be abstracted from the electronic medical record.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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