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Improving Pain Management and Long Term Outcomes Following High Energy Orthopedic Trauma (Pain Study)

NCT01789216 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2021-02-03

No results posted yet for this study

Summary

The purpose of this study is to definitively resolve questions regarding the use of multimodal pharmacologic pain management for orthopedic trauma patients in the context of a multicenter, randomized clinical trial.

Also, as a significant proportion of this population develops chronic post traumatic osteoarthritis (PTOA), a sub-objective of this study is to examine the etiology and incidence of chronic pain and PTOA in this population.

Conditions

  • Orthopaedic Fractures

Interventions

DRUG

NSAID

DRUG

Gabapentinoids

DRUG

placebo

Sponsors & Collaborators

  • Major Extremity Trauma Research Consortium

    lead OTHER

Principal Investigators

  • Renan Castillo, PhD · Johns Hopkins Bloomberg School of Public Health

  • Lawrence Marsh, MD · University of Iowa Hospitals & Clinics

  • Katherine Frey, RN, MPH, MS · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01789216 on ClinicalTrials.gov