NCT05037812

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for early_phase_1

Timeline
22mo left

Started Mar 2019

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Mar 2019Mar 2028

Study Start

First participant enrolled

March 25, 2019

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 8, 2021

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

8.9 years

First QC Date

September 2, 2021

Last Update Submit

April 23, 2026

Conditions

Tibial Plateau Fractures

Keywords

Tibial Plateau FracturesPeriarticular Multimodal AnalgesiaPerioperative Pain

Outcome Measures

Primary Outcomes (7)

  • 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

Study Arms (2)

Saline injection

PLACEBO COMPARATOR

Saline

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.

Drug: Multimodal injections

Interventions

Saline injectionDRUG

Saline

Also known as: 0.9%NaCl (sodium chloride) H2O (saline)
Saline injection
Multimodal injectionsDRUG

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).

Also known as: Morphine sulfate (MS) Contin, Astramorph, Depodur, Duramorph, Infumorph, Kadian, MorphaBond, Arymo ER (morphine), Adrenalin (epinephrine), Catapres, Kapvay (clonidine), Toradol (ketorolac), 0.9%NaCl (sodium chloride) H2O (saline)
Multimodal injections

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Tibial Plateau Fractures

Interventions

Sodium ChlorideMorphineEpinephrineClonidineKetorolac TromethamineKetorolac

Condition Hierarchy (Ancestors)

Knee FracturesFractures, BoneWounds and InjuriesTibial FracturesKnee InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsImidazolinesImidazolesAzolesHeterocyclic Compounds, 1-RingIndomethacinIndolesHeterocyclic Compounds, 2-Ring

Study Officials

  • Justin Haller, MD

    University of Utah Orthopaedics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

September 2, 2021

First Posted

September 8, 2021

Study Start

March 25, 2019

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)