Tibial Plateau FracturesEarly Phase 1NCT05037812
Role of Multimodal Analgesia in Decreasing Perioperative Pain in Tibial Plateau Fractures
A Early Phase 1 study testing Saline injection and Multimodal injections in people with Tibial Plateau Fractures, run by University of Utah at 1 site in United States.
Trial summary
The investigators goal of the proposed research study is to determine the effectiveness of periarticular multimodal analgesia in the setting of tibial plateau fractures. Effectiveness of the multimodal analgesia is defined as lower pain scores. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Tibial Plateau Fractures
- What is being tested?
- Saline injection and Multimodal injections
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2019to Mar 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who present with isolated tibial plateau fractures treated by the investigators
- English or Spanish speaking
Who cannot join
- Poly trauma injuries
- Any allergies to the medication used in the injections
- Significant head trauma (loss of consciousness, Glasgow Coma Scale (GCS)<15, brain bleed) that interferes with the ability to provide informed consent.
- Non-English or Non-Spanish Speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Orthopaedic Center
Salt Lake City, Utah, 84108
About this study
Official title: Determining the Role of Periarticular Multimodal Analgesia in Decreasing Perioperative Pain in Tibial Plateau Fractures
The investigators goal of the proposed research study is to determine the effectiveness of periarticular multimodal analgesia in the setting of tibial plateau fractures. Effectiveness of the multimodal analgesia is defined as lower pain scores.
Read the detailed description
Pain control in the setting of orthopaedic trauma has always been imperative for patient comfort and to enhance functional recovery. However, the current opioid epidemic makes effective pain control even more critical. Furthermore, the Center of Medicare and Medicaid Services have developed tools for rating physician care, of which, pain control is considered a contributing part. The operative management of tibial plateau fractures requires adequate pain control to allow for early motion of the joint. Recently, multimodal pain therapy has been proposed as way to accomplish effective postoperative pain relief. This is difficult for this injury as any form of regional analgesia such as nerve blocks are not possible due to the possibility of compartment syndrome. The goal of the proposed research study is to determine the effectiveness of periarticular multimodal analgesia in the setting of tibial plateau fractures. Effectiveness of the multimodal analgesia is defined as lower pain scores and decreased narcotic intake in the perioperative setting.
The expected outcomes of the study are based on the extensive total knee arthroplasty literature that shows decreased pain and narcotic usage in the peri-operative period with peri-articular multimodal analgesia injections. Furthermore, a recent study by other investigators showed decreased pain and narcotic usage in the first post-operative day following femur fractures of any kind. These data display the promise for the use of peri-articular multimodal analgesia in the setting of tibial plateau fractures.
With the rise of patient-centered care and outcome driven reimbursement, pain control is one of the main factors in both these domains. The Center for Medicaid and Medicare Services has developed the Total Performance Score for Hospitals, which is factored into the reimbursement for provided services. Pain Management is one of the main contributors to the score. Moreover, pain control has been shown to improve patient satisfaction, which is of increasing importance in medicine today.
While some lower extremity fractures can be managed with a nerve block, tibial plateau fractures have a significant risk of developing compartment syndrome that preclude these patients from receiving a nerve block as it does not allow clinical monitoring. As such, the remaining options are to control pain with IV and oral narcotics.
There is no data on the effectiveness of peri-articular multimodal analgesia for tibial plateau fractures. The majority of evidence behind these injections in reducing peri-operative pain and decreasing narcotic use comes from the total knee arthroplasty literature. Numerous studies have investigated the effect of these injections and shown a decrease in perioperative pain and use of perioperative narcotics.
Investigators have looked at multimodal analgesia injections in femur fractures of all kinds. The investigators found that in patients receiving the injection, their pain was decreased over the first postoperative day along with consuming fewer narcotics over the same time frame. Unfortunately, the randomization in these studies resulted in an unequal distribution of injuries that may have biased the results. The investigators noted, "further investigations are required to establish the efficacy of this multimodal protocol for the individual surgical procedures considered". Five patients with tibial plateau fractures have experimentally been treated with a local multimodal analgesia at the applying institution. All five have had a subjectively decreased amount of pain with no evidence of peroneal nerve palsy, compartment syndrome, or infection. If the proposed study finds similar results in decreasing pain and narcotic use, not only would patients have an overall better experience, but this would also help in decreasing narcotic related adverse events in the hospital.
- Conditions
- Tibial Plateau Fractures
- Being tested
- Saline injection, Multimodal injections
- Keywords
- Tibial Plateau Fractures, Periarticular Multimodal Analgesia, Perioperative Pain
- Medical subject headings
- Tibial Plateau Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline injectionDrug
Also called 0.9%NaCl (sodium chloride) H2O (saline)
Saline
Multimodal injectionsDrug
Also called Morphine sulfate (MS) Contin, Astramorph, Depodur, Duramorph, Infumorph, Kadian, MorphaBond, Arymo ER (morphine), Adrenalin (epinephrine), Catapres, Kapvay (clonidine), Toradol (ketorolac)
5mg morphine, 500 micrograms epinephrine, and 4ml normal saline (superficial injection).
2.5mg morphine, 40 micrograms clonidine, 15mg ketorolac, and 4ml normal saline (deep injection).
| Study group | Role | What they receive |
|---|---|---|
| Saline injection | Placebo comparator | Saline Receives: Drug: Saline injection |
| Multimodal injections | Experimental | Superficial multimodal analgesia composition includes 5mg morphine, 500 micrograms epinephrine, and 4ml normal saline.
Deep medial multimodal analgesia composition includes 2.5mg morphine, 40 micrograms clonidine, 15mg ketorolac, and 4ml normal saline. Receives: Drug: Multimodal injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Measured: Pre-operative
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Measured: 4-hours post-operative
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Measured: 8-hours post-operative
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Measured: 12-hours post-operative
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Measured: 16-hours post-operative
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Measured: 20-hours post-operative
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Measured: 24-hours post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start25 Mar 2019
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibial Plateau FracturesStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin Haller, University of Utah
- Investigators
- Justin Haller, MD, Principal investigator, University of Utah Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05037812
- Sponsor's protocol ID
- 117178
- Status last verified
- Apr 2026
- First submitted
- 2 Sep 2021
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Role of Periarticular Multimodal Analgesia in Decreasing Perioperative Pain in Tibial Plateau Fractures
- ClinicalTrials.gov ID
- NCT05037812
- Acronym / sponsor ID
- 117178
- Conditions
- Tibial Plateau Fractures
- Keywords
- Tibial Plateau Fractures, Periarticular Multimodal Analgesia, Perioperative Pain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 8 Sep 2021 (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 investigators goal of the proposed research study is to determine the effectiveness of periarticular multimodal analgesia in the setting of tibial plateau fractures. Effectiveness of the multimodal analgesia is defined as lower pain scores.
Detailed description
Pain control in the setting of orthopaedic trauma has always been imperative for patient comfort and to enhance functional recovery. However, the current opioid epidemic makes effective pain control even more critical. Furthermore, the Center of Medicare and Medicaid Services have developed tools for rating physician care, of which, pain control is considered a contributing part. The operative management of tibial plateau fractures requires adequate pain control to allow for early motion of the joint. Recently, multimodal pain therapy has been proposed as way to accomplish effective postoperative pain relief. This is difficult for this injury as any form of regional analgesia such as nerve blocks are not possible due to the possibility of compartment syndrome. The goal of the proposed research study is to determine the effectiveness of periarticular multimodal analgesia in the setting of tibial plateau fractures. Effectiveness of the multimodal analgesia is defined as lower pain scores and decreased narcotic intake in the perioperative setting.
The expected outcomes of the study are based on the extensive total knee arthroplasty literature that shows decreased pain and narcotic usage in the peri-operative period with peri-articular multimodal analgesia injections. Furthermore, a recent study by other investigators showed decreased pain and narcotic usage in the first post-operative day following femur fractures of any kind. These data display the promise for the use of peri-articular multimodal analgesia in the setting of tibial plateau fractures.
With the rise of patient-centered care and outcome driven reimbursement, pain control is one of the main factors in both these domains. The Center for Medicaid and Medicare Services has developed the Total Performance Score for Hospitals, which is factored into the reimbursement for provided services. Pain Management is one of the main contributors to the score. Moreover, pain control has been shown to improve patient satisfaction, which is of increasing importance in medicine today.
While some lower extremity fractures can be managed with a nerve block, tibial plateau fractures have a significant risk of developing compartment syndrome that preclude these patients from receiving a nerve block as it does not allow clinical monitoring. As such, the remaining options are to control pain with IV and oral narcotics.
There is no data on the effectiveness of peri-articular multimodal analgesia for tibial plateau fractures. The majority of evidence behind these injections in reducing peri-operative pain and decreasing narcotic use comes from the total knee arthroplasty literature. Numerous studies have investigated the effect of these injections and shown a decrease in perioperative pain and use of perioperative narcotics.
Investigators have looked at multimodal analgesia injections in femur fractures of all kinds. The investigators found that in patients receiving the injection, their pain was decreased over the first postoperative day along with consuming fewer narcotics over the same time frame. Unfortunately, the randomization in these studies resulted in an unequal distribution of injuries that may have biased the results. The investigators noted, "further investigations are required to establish the efficacy of this multimodal protocol for the individual surgical procedures considered". Five patients with tibial plateau fractures have experimentally been treated with a local multimodal analgesia at the applying institution. All five have had a subjectively decreased amount of pain with no evidence of peroneal nerve palsy, compartment syndrome, or infection. If the proposed study finds similar results in decreasing pain and narcotic use, not only would patients have an overall better experience, but this would also help in decreasing narcotic related adverse events in the hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline injection | Placebo comparator | Drug: Saline injectionSaline |
| Multimodal injections | Experimental | Drug: Multimodal injectionsSuperficial multimodal analgesia composition includes 5mg morphine, 500 micrograms epinephrine, and 4ml normal saline. Deep medial multimodal analgesia composition includes 2.5mg morphine, 40 micrograms clonidine, 15mg ketorolac, and 4ml normal saline. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who present with isolated tibial plateau fractures treated by the investigators
- English or Spanish speaking
Key exclusion criteria (4 listed)
- Poly trauma injuries
- Any allergies to the medication used in the injections
- Significant head trauma (loss of consciousness, Glasgow Coma Scale (GCS)<15, brain bleed) that interferes with the ability to provide informed consent.
- Non-English or Non-Spanish Speaking
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 |
|---|---|---|
| Saline injectionAlso: 0.9%NaCl (sodium chloride) H2O (saline)Saline | Drug | Saline injection |
| Multimodal injectionsAlso: Morphine sulfate (MS) Contin, Astramorph, Depodur, Duramorph, Infumorph, Kadian, MorphaBond, Arymo ER (morphine), Adrenalin (epinephrine), Catapres, Kapvay (clonidine), Toradol (ketorolac)5mg morphine, 500 micrograms epinephrine, and 4ml normal saline (superficial injection). 2.5mg morphine, 40 micrograms clonidine, 15mg ketorolac, and 4ml normal saline (deep injection). | Drug | Multimodal injections |
Primary outcome
Visual Analog Scale (VAS) pain
Time frame: Pre-operative
VAS pain score (0 no pain - 10 severe pain)
Visual Analog Scale (VAS) pain
Time frame: 4-hours post-operative
VAS pain score (0 no pain - 10 severe pain)
Visual Analog Scale (VAS) pain
Time frame: 8-hours post-operative
VAS pain score (0 no pain - 10 severe pain)
Visual Analog Scale (VAS) pain
Time frame: 12-hours post-operative
VAS pain score (0 no pain - 10 severe pain)
Visual Analog Scale (VAS) pain
Time frame: 16-hours post-operative
VAS pain score (0 no pain - 10 severe pain)
Visual Analog Scale (VAS) pain
Time frame: 20-hours post-operative
VAS pain score (0 no pain - 10 severe pain)
Visual Analog Scale (VAS) pain
Time frame: 24-hours post-operative
VAS pain score (0 no pain - 10 severe pain)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- 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.
Justin Haller, MD principal investigator
University of Utah Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Saline injection and Multimodal injections in people with Tibial Plateau Fractures, run by University of Utah at 1 site 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 4 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: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Visual Analog Scale (VAS) pain (time frame: Pre-operative). The study lists 7 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 29 Apr 2026.