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

150 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 multimodal pain relief safe for humans?

Multimodal pain relief, including surgical-site drug injections, has been shown to be safe in various studies for different types of fractures, such as clavicular and femoral fractures. These studies suggest that this approach is generally safe for managing pain in humans. ^{1 2 3 4 5}

How is the multimodal injection treatment for tibial plateau fractures different from other treatments?

Multimodal injections for tibial plateau fractures are unique because they combine different types of pain relief methods into a single treatment, potentially reducing the need for more invasive surgical procedures and minimizing additional trauma to the area. ^{6 7 8 9 10}

Research Team

Justin Haller, MD

Principal Investigator

University of Utah Orthopaedics

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Periarticular multimodal analgesia in decreasing perioperative pain in tibial plateau fractures: A double blind randomized controlled pilot study. [2022]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Effect of Surgical-Site, Multimodal Drug Injection on Pain and Stress Biomarkers in Patients Undergoing Plate Fixation for Clavicular Fractures. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Surgical-Site, Multimodal Drug Injection Following Operative Management of Femoral Fractures: A Randomized Controlled Trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Multimodal analgesia is superior to opiates alone after tibial fracture in patients with substance abuse history. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Regional Anesthesia Is Safe and Effective for Low-Energy Tibial Plateau Fractures. [2023]

6. China pubmed.ncbi.nlm.nih.gov

[Treatment of complex tibial plateau fractures with bilateral locking plate and bone graft]. [2016]

7. Germany pubmed.ncbi.nlm.nih.gov

Correction of lateral tibial plateau depression and valgus malunion of the proximal tibia. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Frequency and fracture morphology of the posteromedial fragment in bicondylar tibial plateau fracture patterns. [2022]

9. China pubmed.ncbi.nlm.nih.gov

[Arthroscopic percutaneous osteosynthesis of low-energy tibial plateau fractures]. [2019]

10. Germany pubmed.ncbi.nlm.nih.gov

[Minimally invasive treatment of monocondylar tibial plateau fractures. Percutaneous reduction and small fragment osteosynthesis]. [2018]