Comparison of Epidural and Paracostal Catheter Placement for Pain Control After Rib Fractures (NCT02295098) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Epidural and Paracostal Catheter Placement for Pain Control After Rib Fractures
United States36 participantsStarted 2015-08-19
Plain-language summary
The investigators plan to compare the incidence of successful placement of epidural pain catheters versus paracostal catheters for the control of pain and prevention of pulmonary complications for adult trauma patients with blunt chest wall trauma resulting in multiple rib fractures. When a trauma patient has \> or = to 3 rib fractures on the same side, is being admitted to the Surgical ICU, and is encountered within 72 hours from the time of their injury, they will be eligible for the study. If they (or a proxy) choose to participate, consent will be obtained and they will randomly be assigned to receive either an epidural or paracostal catheter for pain control. The aim of the study is to determine if paracostal catheters are noninferior to epidurals for controlling pain in multisystem trauma patients. Secondarily the investigators will evaluate success and time of placement of the assigned intervention and follow the patient throughout their hospital course to compare the success of analgesia provided by each modality along with any complications and/or benefits of the two types of catheters.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Localized rash or skin infection over the likely site of insertion (We never want to translocate infectious material from the skin to the epidural space or even into the soft tissue where paracostal catheters lay, although for these there is more flexibility in adjusting placement)
. Spinal/vertebral instability/fracture including any significant vertebral body injury and 3 or more spinous process fractures near the level of desired epidural placement (transverse process fractures are not considered a contraindication)
. History of extensive back surgery at the level of desired epidural placement
. Severe aortic stenosis, mitral stenosis, or pulmonary hypertension
. Inability to correct coagulopathy (to International Normalized Ratio\>1.5)
. Persistent hemodynamic instability (hypotension with Systolic Blood Pressure\<90 that does not respond to initial fluid boluses and requires ongoing pressors beyond the 72 hour window for enrollment)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain assessment immediately before and after catheter placement
Timeframe: within an hour before and after catheter placement
. Inability to cooperate and participate in placement (if intubated and sedated, for example) or to lie in the correct position for placement (lateral decubitus for paracostal pain catheters, either sitting up or lateral decubitus for epidural placement)
. Concern for elevated intracranial pressure (we imagine these patients will also be intubated)