NCT05019638

Brief Summary

The investigators plan to evaluate the efficacy in reducing post-operative pain between local multimodal analgesia as compared to regional anesthesia in rotational ankle fractures.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for early_phase_1

Timeline
24mo left

Started Mar 2021

Longer than P75 for early_phase_1

Geographic Reach
1 country

2 active sites

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 Progress72%
Mar 2021May 2028

Study Start

First participant enrolled

March 15, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 25, 2021

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

7.1 years

First QC Date

July 19, 2021

Last Update Submit

April 23, 2026

Conditions

Ankle Fractures

Keywords

rotational ankle fracturesregional anesthesialocal multimodal injectionpain

Outcome Measures

Primary Outcomes (6)

  • 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)

    1-hour post-operative

  • Visual Analog Scale (VAS) pain

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

    2-hour post -operative

  • Visual Analog Scale (VAS) pain

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

    4-hour post-operative

  • Visual Analog Scale (VAS) pain

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

    8-hour post-operative

  • Visual Analog Scale (VAS) pain

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

    24-hour post-operative

Study Arms (2)

Regional anesthesia group

ACTIVE COMPARATOR

Standard single-shot anesthesia consists of bupivacaine 0.25% with epinephrine 1:400,000.

Drug: Regional anesthesia group

Local multimodal analgesia group

EXPERIMENTAL

Local multimodal analgesia composition will include 5mg of morphine, 500 mg of epinephrine, 15mg of ketorolac, and 20mg of bupivacaine.

Drug: Local multimodal analgesia group

Interventions

Regional anesthesia groupDRUG

bupivacaine 0.25% with epinephrine 1:400,000.

Also known as: Marcaine (bupivacaine), Adrenalin (epinephrine)
Regional anesthesia group
Local multimodal analgesia groupDRUG

5mg of morphine, 500 mg of epinephrine, 15mg of ketorolac, and 20mg of bupivacaine.

Also known as: MS Contin, Astramorph, Depodur, Duramorph, Infumorph, Kadian, MorphaBond, Arymo ER (morphine), Adrenalin (epinephrine), Toradol (ketorolac), Marcaine (bupivacaine)
Local multimodal analgesia group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • isolated rotational ankle fracture
  • operative intervention needed
  • English or Spanish speaking
  • provide informed consent
  • able to communicate with the research team via email or phone

You may not qualify if:

  • sustain concomitant head injury
  • additional lower extremity fracture(s)
  • open fracture
  • prior drug dependency
  • allergies to any of the ingredients in the local injection or peripheral nerve block
  • any history of stroke
  • major neurological deficit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108, United States

Location

University of Utah Orthopedics

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Ankle FracturesPain

Interventions

BupivacaineEpinephrineMorphineKetorolac TromethamineKetorolac

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesAnkle InjuriesLeg InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesEthanolaminesAmino AlcoholsAlcoholsBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsIndomethacinIndolesHeterocyclic 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

July 19, 2021

First Posted

August 25, 2021

Study Start

March 15, 2021

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)