Optimal Method of Pain Management in Patients With Multiple Rib Fractures
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|ClinicalTrials.gov Identifier: NCT01401712|
Recruitment Status : Unknown
Verified October 2013 by George Velmahos, Massachusetts General Hospital.
Recruitment status was: Recruiting
First Posted : July 25, 2011
Last Update Posted : October 29, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|3 or More Rib Fractures||Procedure: ON-Q® Pain Relief System Procedure: Thoracic epidural catheter||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Thoracic Epidural Analgesia Compared to Thoracic Paravertebral Pump Infusion for Pain Management in Patients With Three or More Rib Fractures|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||April 2014|
|Estimated Study Completion Date :||October 2014|
|Experimental: Paravertebral catheter (ON-Q® Pain Relief System)||
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.
|Active Comparator: Thoracic epidural catheter||
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.
- Hospital length of stay/time to achieve discharge criteria [ Time Frame: Patient will be followed for the duration of hospital stay, 1 week ]
The study will compare the time to achieve discharge criteria between the two groups. Readiness for discharge is defined by the following criteria:
- Visual Analog Score (VAS) for pain below 4 (of a maximum 10);
- Ability to perform incentive spirometry with sustained maximal inspiration for three seconds;
- Hemodynamic stability (heart rate <100 beats/min, respiratory rate <20 breaths/min, and systolic blood pressure >90mmHg at 3 consecutive time points that are 10 minutes apart) and oxygen saturation greater than 95% on room air;
- Absence of neurological deficits; and
- Monitored for at least 1 hour after ON Q® catheter placement to ensure no immediate complications from placement or local anesthestic toxicity.
- Pain score reduction [ Time Frame: Patient will be followed for duration of hospital stay and through daily phone calls upon discharge ]Decrease in pain as measured by the Visual Analog Scale (VAS) pre-placement and 60 min post-placement of intervention. Pain score will be followed for the duration of the intervention.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01401712
|Contact: Katharine M Koury, BAemail@example.com|
|Contact: Leily Naraghi, MDfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Katharine M Koury, BA 617-643-7095 email@example.com|
|Principal Investigator: George C Velmahos, MD, PhD|
|Sub-Investigator: Padma Gulur, MD|
|Principal Investigator:||George C Velmahos, Md, PhD||Massachusetts General Hospital|