Role of Multimodal Analgesia in Decreasing Perioperative Pain in Tibial Plateau Fractures

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Tibial Plateau Fractures
• Intervention / Treatment: Drug: Saline injection; Drug: Multimodal injections

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 Type: Interventional
• Enrollment (Estimated): 150
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University of Utah Orthopaedic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who present with isolated tibial plateau fractures treated by the investigators
• English or Spanish speaking

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Saline injection; Saline	Drug: Saline injection; Saline; Other Names: 0.9%NaCl (sodium chloride) H2O (saline)
Experimental: Multimodal injections; 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.	Drug: Multimodal injections; 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).; Other Names: 0.9%NaCl (sodium chloride) H2O (saline); Morphine sulfate (MS) Contin, Astramorph, Depodur, Duramorph, Infumorph, Kadian, MorphaBond, Arymo ER (morphine); Adrenalin (epinephrine); Catapres, Kapvay (clonidine); Toradol (ketorolac)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS) pain	VAS pain score (0 no pain - 10 severe pain)	Pre-operative
Visual Analog Scale (VAS) pain	VAS pain score (0 no pain - 10 severe pain)	4-hours post-operative
Visual Analog Scale (VAS) pain	VAS pain score (0 no pain - 10 severe pain)	8-hours post-operative
Visual Analog Scale (VAS) pain	VAS pain score (0 no pain - 10 severe pain)	12-hours post-operative
Visual Analog Scale (VAS) pain	VAS pain score (0 no pain - 10 severe pain)	16-hours post-operative
Visual Analog Scale (VAS) pain	VAS pain score (0 no pain - 10 severe pain)	20-hours post-operative
Visual Analog Scale (VAS) pain	VAS pain score (0 no pain - 10 severe pain)	24-hours post-operative

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Justin Haller, MD, University of Utah Orthopaedics

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2019
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: September 2, 2021
• First Submitted That Met QC Criteria: September 2, 2021
• First Posted (Actual): September 8, 2021

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Perioperative Pain; Tibial Plateau Fractures; Periarticular Multimodal Analgesia
• Additional Relevant MeSH Terms: Knee Fractures; Wounds and Injuries; Leg Injuries; Fractures, Bone; Knee Injuries; Tibial Fractures; Tibial Plateau Fractures; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Azoles; Hydrocarbons; Hydrocarbons, Cyclic; Alkaloids; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Imidazoles; Amines; Indomethacin; Indoles; Inorganic Chemicals; Chlorine Compounds; Catechols; Phenols; Benzene Derivatives; Alcohols; Heterocyclic Compounds, 4 or More Rings; Amino Alcohols; Ethanolamines; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Morphine Derivatives; Biogenic Monoamines; Biogenic Amines; Catecholamines; Sodium Compounds; Chlorides; Hydrochloric Acid; Imidazolines; Morphine; Ketorolac; Epinephrine; Ketorolac Tromethamine; Clonidine; Sodium Chloride
• Other Study ID Numbers: 117178

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No