Tibial Plateau FracturePhase 4NCT04639011
Duloxetine Tibial Plateau
A Phase 4 study testing Duloxetine in people with Tibial Plateau Fracture and Pain, Postoperative, run by Boston Medical Center at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tibial Plateau Fracture, Pain, Postoperative
- What is being tested?
- Duloxetine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2022to Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Tibial plateau fracture that requires operative fixation
- Ambulatory patient prior to fracture
Who cannot join
- 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)
Show all 19Show fewer
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Boston Medical Center
Boston, Massachusetts, 02118
Westchester Medical Center
Valhalla, New York, 10595
About this study
Official title: Effects of Duloxetine on Postoperative Pain Control and Knee Rehabilitation After Open Reduction Internal Fixation of Tibial Plateau Fractures
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.
- Conditions
- Tibial Plateau Fracture, Pain, Postoperative
- Being tested
- Duloxetine, Placebo, Standard of care (SOC) for tibial plateau surgery
- Keywords
- Duloxetine, VAS pain scores, Patient Controlled Analgesia (PCA)
- Medical subject headings
- Tibial Plateau Fractures, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
Also called Serotonin-norepinephrine reuptake inhibitor (SNRI)
Three doses of 60 mg of oral duloxetine will be given to participants (right before operation, postop day 1, postop day 2)
PlaceboOther
Also called Sugar pill
Three doses of placebo will be given to participants (right before operation, postop day 1, postop day 2).
Standard of care (SOC) for tibial plateau surgeryOther
Postoperative IV administration of opioids via a patient controlled analgesia (PCA) system which utilizes a hydromorphone pump.
| Study group | Role | What they receive |
|---|---|---|
| Group A Placebo | Active comparator | Participants randomized to Group A will receive placebo (sugar pill) and Boston Medical Center (BMC) standard of care. Receives: Other: Placebo; Other: Standard of care (SOC) for tibial plateau surgery |
| Groups B Intervention | Experimental | Participants randomized to Group B will receive duloxetine and Boston Medical Center (BMC) standard of care. Receives: Drug: Duloxetine; Other: Standard of care (SOC) for tibial plateau surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: every 4 hours up to 16 hours
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.
Measured: 24 hours
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.
Measured: 36 hours
Secondary outcomes (7)
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.
Measured: up to 10 days post op
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.
Measured: 6 weeks, 12 weeks
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.
Measured: 6 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Ambulation (walking) distance on post-op days 1 or 2
The walking distance will be abstracted from the electronic medical record.
Measured: Up to 2 days post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study startOct 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Study was not conducted because funding was not obtained.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibial Plateau FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seroos Salavati, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639011
- Sponsor's protocol ID
- H-40569
- Status last verified
- Nov 2022
- First submitted
- 16 Nov 2020
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Duloxetine on Postoperative Pain Control and Knee Rehabilitation After Open Reduction Internal Fixation of Tibial Plateau Fractures
- ClinicalTrials.gov ID
- NCT04639011
- Acronym / sponsor ID
- H-40569
- Conditions
- Tibial Plateau Fracture, Pain, Postoperative
- Keywords
- Duloxetine, VAS pain scores, Patient Controlled Analgesia (PCA)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not conducted because funding was not obtained.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A Placebo | Active comparator | Other: Placebo, Other: Standard of care (SOC) for tibial plateau surgeryParticipants randomized to Group A will receive placebo (sugar pill) and Boston Medical Center (BMC) standard of care. |
| Groups B Intervention | Experimental | Drug: Duloxetine, Other: Standard of care (SOC) for tibial plateau surgeryParticipants randomized to Group B will receive duloxetine and Boston Medical Center (BMC) standard of care. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Tibial plateau fracture that requires operative fixation
- Ambulatory patient prior to fracture
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DuloxetineAlso: Serotonin-norepinephrine reuptake inhibitor (SNRI)Three doses of 60 mg of oral duloxetine will be given to participants (right before operation, postop day 1, postop day 2) | Drug | Groups B Intervention |
| PlaceboAlso: Sugar pillThree doses of placebo will be given to participants (right before operation, postop day 1, postop day 2). | Other | Group A Placebo |
| Standard of care (SOC) for tibial plateau surgeryPostoperative IV administration of opioids via a patient controlled analgesia (PCA) system which utilizes a hydromorphone pump. | Other | Group A Placebo, Groups B Intervention |
Primary outcome
Pain levels in the first 16 hours after surgery
Time frame: 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
Time frame: 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
Time frame: 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.
7 secondary outcomes
Total morphine consumption
Time frame: up to 10 days post op
Change in knee range of motion
Time frame: 6 weeks, 12 weeks
Self reported functional status at 6 weeks
Time frame: 6 weeks
Self reported functional status at 12 weeks
Time frame: 12 weeks
Hospital length of stay
Time frame: 12 weeks
Time to mobilization (starting to walk)
Time frame: 12 weeks
Ambulation (walking) distance on post-op days 1 or 2
Time frame: Up to 2 days post op
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seroos Salavati, MD principal investigator
Boston Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Duloxetine in people with Tibial Plateau Fracture and Pain, Postoperative, run by Boston Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain levels in the first 16 hours after surgery (time frame: every 4 hours up to 16 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2022; AzTrials last refreshed its copy on 31 Oct 2026.