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Optimal Method of Pain Management in Patients With Multiple Rib Fractures

NCT01401712 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2013-10-29

No results posted yet for this study

Summary

Rib fractures are a common injury of trauma patients and can cause significant pain which, if inadequately treated, can lead to impaired breathing, lung collapse, and respiratory failure. Hence, it is crucial to manage pain associated with rib fractures. Currently, epidurals are used to treat the pain, but placement can be risky as rib fractures are often associated with other injuries and complications.

An alternative pain management option is the ON-Q® Pain Relief System. It is an FDA-approved device that automatically and continuously delivers medication to the region of the thoracic intercostal nerves. One study by Truitt et al (2010)demonstrated that the ON-Q® system effectively reduced pain and increased lung volumes after one hour, in patients with three or more rib fractures. However, that study sample was small and did not have a comparison group. In this study, we will compare two groups: 1) ON-Q system and 2) epidural analgesia. We hypothesize that trauma patients with three or more rib fractures, who receive pain management through the ON-Q® Pain Relief System achieve discharge criteria earlier and thus have a shorter hospital length of stay (LOS) when compared with epidural analgesia.

Conditions

  • 3 or More Rib Fractures

Interventions

PROCEDURE

ON-Q® Pain Relief System

Identify insertion site lateral to paraspinous muscles and posteromedial to the rib fractures. Then, incise skin and soft tissue down to the level of the rib. Advance tunneler perpendicular to chest wall until it contacts the rib, then, advance superiorly at 45° angle in the extrathoracic space. Remove tunneler and advance catheter in space created. Attach catheter to pump filled with 0.2% ropivacaine at infusion rate of 2-12ml/hr.

PROCEDURE

Thoracic epidural catheter

Introduce needle into the interspinous space of the vertebral column and advance into the epidural space. Advance the epidural catheter about 3-5 cm into the epidural space and remove the needle.

Sponsors & Collaborators

  • I-Flow

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • George C Velmahos, Md, PhD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-04-30
Completion
2014-10-31

Countries

  • United States

Study Locations

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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 NCT01401712 on ClinicalTrials.gov