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Duloxetine Tibial Plateau

Primary Purpose

Tibial Plateau Fracture, Pain, Postoperative

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Duloxetine
Placebo
Standard of care (SOC) for tibial plateau surgery
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tibial Plateau Fracture focused on measuring Duloxetine, VAS pain scores, Patient Controlled Analgesia (PCA)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Boston Medical Center
  • Westchester Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A Placebo

Groups B Intervention

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pain levels in the first 16 hours after surgery
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
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
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
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
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
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
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
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)
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
The walking distance will be abstracted from the electronic medical record.

Full Information

First Posted
November 16, 2020
Last Updated
November 18, 2022
Sponsor
Boston Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04639011
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Study was not conducted because funding was not obtained.
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tibial Plateau Fracture, Pain, Postoperative
Keywords
Duloxetine, VAS pain scores, Patient Controlled Analgesia (PCA)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A Placebo
Arm Type
Active Comparator
Arm Description
Participants randomized to Group A will receive placebo (sugar pill) and Boston Medical Center (BMC) standard of care.
Arm Title
Groups B Intervention
Arm Type
Experimental
Arm Description
Participants randomized to Group B will receive duloxetine and Boston Medical Center (BMC) standard of care.
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Other Intervention Name(s)
Serotonin-norepinephrine reuptake inhibitor (SNRI)
Intervention Description
Three doses of 60 mg of oral duloxetine will be given to participants (right before operation, postop day 1, postop day 2)
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Intervention Description
Three doses of placebo will be given to participants (right before operation, postop day 1, postop day 2).
Intervention Type
Other
Intervention Name(s)
Standard of care (SOC) for tibial plateau surgery
Intervention Description
Postoperative IV administration of opioids via a patient controlled analgesia (PCA) system which utilizes a hydromorphone pump.
Primary Outcome Measure Information:
Title
Pain levels in the first 16 hours after surgery
Description
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.
Time Frame
every 4 hours up to 16 hours
Title
Pain level 24 hours after surgery
Description
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.
Time Frame
24 hours
Title
Pain level 36 hours after surgery
Description
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.
Time Frame
36 hours
Secondary Outcome Measure Information:
Title
Total morphine consumption
Description
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.
Time Frame
up to 10 days post op
Title
Change in knee range of motion
Description
The knee range of motion will be abstracted from the electronic medical record. Knee range of motion ranges from 0 to 140 degrees.
Time Frame
6 weeks, 12 weeks
Title
Self reported functional status at 6 weeks
Description
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.
Time Frame
6 weeks
Title
Self reported functional status at 12 weeks
Description
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.
Time Frame
12 weeks
Title
Hospital length of stay
Description
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 Frame
12 weeks
Title
Time to mobilization (starting to walk)
Description
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.
Time Frame
12 weeks
Title
Ambulation (walking) distance on post-op days 1 or 2
Description
The walking distance will be abstracted from the electronic medical record.
Time Frame
Up to 2 days post op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seroos Salavati, MD
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Westchester Medical Center
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Duloxetine Tibial Plateau

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