Thoracic Blocks Versus Thoracic Epidural and Patient Controlled Anesthesia in Traumatic Rib Fract… (NCT01599403) | Clinical Trial Compass
CompletedNot Applicable
Thoracic Blocks Versus Thoracic Epidural and Patient Controlled Anesthesia in Traumatic Rib Fracture Patients
United States50 participantsStarted 2012-04
Plain-language summary
The primary objective of this study is to investigate whether continuous PVB is equal in efficacy to epidural anesthesia in terms of analgesia in patients with INR lower than 1.2, or is continuous ICNB equal in efficacy to PCA in terms of analgesia, if patients have INRs equal to or greater than 1.2.
Who can participate
Age range
18 Years – 100 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.
Eligibility Criteria
A subject must meet the following criteria to take part in the study:
Inclusion Criteria
* Subjects 18 years of age and greater
* Inpatient on the BWH SICU, MICU, or hospital floor ward
* Non-intubated at the time of block placement
* Traumatic Rib Fractures three or greater
* Block able to be placed within 12-24 hours of presentation to the emergency room
* Ability to provide written informed consent.
* Compliance with all ASRA and BWH Regional Anesthesia in Anticoagulated Patient guidelines for coagulation status.
Exclusion Criteria:
* Subject is pregnant
* Subject not expected to survive 48 hours due to traumatic injuries
* Allergy to Ropivacaine or other local anesthetic
* Any significant concomitant injuries potentially confounding data acquisition (e.g., traumatic brain injury, long bone fractures, intra-abdominal injuries)
* Known allergy to lidocaine
* Inability to provide written, informed consent
* Known opioid medication dependence
* Non-compliance with ARSA and BWH Regional Anesthesia in Anticoagulated Patient Guidelines.
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
Primary Outcome: Difference in Pain Scores at 48hrs