ClinicalTrials.gg
Status unknownNCT03359031Updated Dec 2, 2017

Effects of Perioperative Patient Education Regarding Compartment Syndrome on Post-operative Opioid Consumption

An interventional study of Patient education in Compartment Syndrome of Leg, sponsored by Rothman Institute Orthopaedics. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-02.

Sponsored by Rothman Institute Orthopaedics · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Nov 2017), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
134
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 24 studies in Compartment Syndromes with a site in United States — 2 open to participants now, 3 under way, none of them phase 3. Compartment Syndromes · United States.

Planned enrollment
3rd of 17
134 · median 18
Started
2017
the only one that year
No phase
8 of 24
1 open now
Registered
14th of 24
by date

Among the 24 studies in Compartment Syndromes with a site in United States, this one is the 3rd largest by planned enrollment of the 17 interventional ones, is the only one that started in 2017, is one of 8 with no phase, and was the 14th registered.

By phase

24 studies; the count open now beside each. This study's row is marked.

No phasethis study8 · 1 open
Observational7 · 1 open
Phase 14 · 0 open
Phase 43 · 0 open
Phase 1/21 · 0 open
Phase 31 · 0 open

By the year they started

First in 2002; this study’s year is marked. 1 started in 2017.

Size and results

Median enrollment 18 across the 17 interventional studies, 44 across the 7 observational. Of the 14 that completed or were terminated, 3 (21%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 24 studies in Compartment Syndromes with a site in United States, or all of them as a file.
02

Study summary

This study is a prospective, randomized trial. Our study aims to study the effects of perioperative patient education about compartment syndrome on patients' perception of their own pain, amount of opioid medication utilization, and rate of diagnosis of compartment syndrome.

03

Conditions studied

  • Compartment Syndrome of Leg

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04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patients with lower extremity trauma at risk for developing compartment syndrome specifically tibial plateau fractures, tibial/fibular shaft fractures, pilon fractures, and crush injuries.

Exclusion criteria

Exclusion Criteria:

Patients with an extensive history of narcotic medication or drug use, polytrauma patients, and non-primary English speaking patients

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
134 participants (estimated)

Study arms

  • No intervention
    No patient education

    This group of patients will not receive any additional information beyond standard of care educational pamphlets provided by the hospital.

  • Other
    Patient education

    This group of patients will be given a pamphlet on pain control, narcotic medication, and compartment syndrome including its pathophysiology, signs/symptoms, and treatment.

    Other: Patient education

Interventions

  • OtherPatient education

    This group will be given a pamphlet on pain control, narcotic medication, and compartment syndrome including its pathophysiology, signs/symptoms, and treatment.

06

What researchers measure

Primary outcomes

  1. narcotic consumption

    Perioperative

    Time frame: total opioid consumption from surgery through 30 days post-op

07

Study locations

1 site
  • Rothman Institute
    Philadelphia, Pennsylvania 19107, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2017 (actual). Primary completion is estimated for Nov 2018, 12 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 27, 2017
First posted
Dec 2, 2017
StartActual
Nov 13, 2017
Primary completionEst.
Nov 2018
CompletionEst.
Nov 2018
Last update
Dec 2, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 2, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03359031
Responsible party
Sponsor
First posted
Dec 2, 2017
Start date
Nov 13, 2017
Primary completion
Nov 2018 (estimated)
Completion
Nov 2018 (estimated)
Last update
Dec 2, 2017

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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