Multimodal Pain Relief for Tibial Plateau Fractures

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Utah

Disqualifiers: Poly trauma, Significant head trauma, others

Compensation: Varies

Number of Visits: 2

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for managing pain in individuals with tibial plateau fractures, which are breaks in the upper part of the shinbone and can be quite painful. Researchers aim to determine if a special mix of pain-relieving injections (multimodal injections) reduces pain more effectively than a simple saline solution. The trial includes two groups: one receives multimodal injections with pain-relieving medicine, and the other receives a saline solution as a placebo (inactive treatment). Candidates with a tibial plateau fracture who speak English or Spanish may qualify. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative pain management approach.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that a combination of injections for tibial plateau fractures can help reduce post-surgery pain. However, limited information exists about their safety. These injections include medications like morphine, epinephrine, clonidine, and ketorolac, commonly used in medical treatments.

Since this study is in its early stages, researchers focus on determining safe dosage levels and monitoring for side effects. Specific data on any negative effects of these injections is not yet available.

Participants considering joining a trial for these injections should know that the treatment is still under testing, and safety details are being refined. Researchers will closely monitor participants to ensure safety and record any reactions to the treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the multimodal injections for tibial plateau fractures because they offer a novel combination of pain relief agents that work together for enhanced effectiveness. Unlike standard options that often rely on single medications like opioids or NSAIDs, this treatment combines morphine, epinephrine, clonidine, and ketorolac in a multimodal approach, potentially providing more comprehensive pain management. This combination targets different pain pathways simultaneously, which could lead to faster and more effective relief with potentially fewer side effects. Additionally, the use of both superficial and deep injections allows for targeted pain control, which is not commonly seen in current treatment methods.

What evidence suggests that multimodal injections might be an effective treatment for tibial plateau fractures?

This trial will compare the effectiveness of multimodal injections with a placebo saline injection for pain relief after surgery for tibial plateau fractures. Research has shown that a combination of injections can help reduce pain after surgery for certain knee fractures. In earlier studies, patients who received these multimodal injections, which include pain-relieving drugs like morphine and ketorolac, experienced less short-term pain. Although more research is needed, early results are promising for this treatment in managing pain from these fractures. ^{1 2 3 4 6}

Who Is on the Research Team?

Justin Haller, MD

Principal Investigator

University of Utah Orthopaedics

Are You a Good Fit for This Trial?

This trial is for English or Spanish speakers with isolated tibial plateau fractures treated by the study's investigators. It excludes those allergic to injection medications, with significant head trauma affecting consent ability, and patients with multiple traumatic injuries.

Inclusion Criteria

I have a tibial plateau fracture treated by the study's doctors.

Exclusion Criteria

You have multiple injuries from an accident or trauma.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive periarticular multimodal analgesia or placebo injections during the perioperative period for tibial plateau fractures

1 week

1 visit (in-person)

Follow-up

Participants are monitored for pain levels and narcotic usage post-operatively

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Multimodal injections

Trial Overview The study tests the effectiveness of multimodal analgesia injections versus saline injections in reducing pain after tibial plateau fracture surgery. Effectiveness is measured by lower reported pain scores from patients.

How Is the Trial Designed?

Group I: Multimodal injections Experimental Treatment 1 Intervention

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.

Group II: Saline injection Placebo Group 1 Intervention

Saline

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Published Research Related to This Trial

In a study of 102 patients undergoing surgery for femoral fractures, a multimodal analgesic injection containing ropivacaine, epinephrine, and morphine significantly reduced postoperative pain levels compared to a control group, as measured by visual analog scale (VAS) scores at multiple time points.

The injection group also required significantly less narcotic medication in the first 8 hours post-surgery, with no observed adverse effects from the local anesthetic, indicating both safety and efficacy of this pain management approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Surgical-Site, Multimodal Drug Injection Following Operative Management of Femoral Fractures: A Randomized Controlled Trial. Koehler, D., Marsh, JL., Karam, M., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36207154/

A double blind randomized controlled pilot study The use of local multimodal periarticular analgesic for closed tibial plateau fractures appears to be beneficial for short-term pain control post-operatively.

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05037812

Role of Multimodal Analgesia in Decreasing Perioperative ... There is no data on the effectiveness of peri-articular multimodal analgesia for tibial plateau fractures. The majority of evidence behind these injections ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020138322007197

Periarticular multimodal analgesia in decreasing ... The use of local multimodal periarticular analgesic for closed tibial plateau fractures appears to be beneficial for short-term pain control post-operatively.

4. clinicaltrial.be clinicaltrial.be/en/details/176251?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Role of Multimodal Analgesia in Decreasing Perioperative... The goal of the proposed research study is to determine the effectiveness of periarticular multimodal analgesia in the setting of tibial plateau ...

5. injuryjournal.com injuryjournal.com/article/S0020-1383(22)00719-7/abstract

A double blind randomized controlled pilot study Multimodal pain injections for tibial plateau fractures appears to have some benefit for post-operative pain control.

6. researchgate.net researchgate.net/publication/364161874_Periarticular_Multimodal_Analgesia_in_Decreasing_Perioperative_Pain_in_Tibial_Plateau_Fractures_A_Double_Blind_Randomized_Controlled_Pilot_Study

A Double Blind Randomized Controlled Pilot Study Periarticular Multimodal Analgesia in Decreasing Perioperative Pain in Tibial Plateau Fractures: A Double Blind Randomized Controlled Pilot Study ; Patrick J.