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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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

Other trials in United States

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.

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 groups in NCT05037812
Study groupRoleWhat they receive
Saline injectionPlacebo comparatorSaline
Receives: Drug: Saline injection
Multimodal injectionsExperimentalSuperficial 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.

  1. Visual Analog Scale (VAS) pain

    VAS pain score (0 no pain - 10 severe pain)

    Measured: Pre-operative

  2. Visual Analog Scale (VAS) pain

    VAS pain score (0 no pain - 10 severe pain)

    Measured: 4-hours post-operative

  3. Visual Analog Scale (VAS) pain

    VAS pain score (0 no pain - 10 severe pain)

    Measured: 8-hours post-operative

  4. Visual Analog Scale (VAS) pain

    VAS pain score (0 no pain - 10 severe pain)

    Measured: 12-hours post-operative

  5. Visual Analog Scale (VAS) pain

    VAS pain score (0 no pain - 10 severe pain)

    Measured: 16-hours post-operative

  6. Visual Analog Scale (VAS) pain

    VAS pain score (0 no pain - 10 severe pain)

    Measured: 20-hours post-operative

  7. 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.

  1. First posted8 Sep 2021
  2. Study start25 Mar 2019
  3. Primary completionMar 2028 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

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)
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

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.

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