PVB vs Ketamine/Lidocaine in Rib Fracture Patients (NCT04413799) | Clinical Trial Compass
TerminatedEarly Phase 1
PVB vs Ketamine/Lidocaine in Rib Fracture Patients
Stopped: not enough enrollment
United States32 participantsStarted 2020-09-01
Plain-language summary
Rib fractures are a common admission to the trauma service. The mainstay of treatment is pain control to improve respiratory effort in order to offset the risk of pneumonia and mechanical ventilation. In addition to standard pain control modalities, the investigator's institution utilizes paravertebral blocks as well as lidocaine and ketamine infusions for pain control. The current standard of care for pain control is to begin with acetaminophen, ibuprofen or celecoxib and opioids with the addition of paravertebral blocks as needed. In certain situations, a paravertebral block is contraindicated, and pain control is relegated to lidocaine and ketamine infusion. The use of lidocaine infusion alone and ketamine infusion alone for pain control has been studied and has been shown to be safe. However, concurrent use of these two medications to control rib fracture pain is relatively new and the efficacy compared to paravertebral block is not known. The goal of the study is to show non-inferiority of simultaneous lidocaine and ketamine infusions versus paravertebral blocks.
Who can participate
Age range
18 Years – 80 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.
Inclusion Criteria:
* age 18-80 with rib fracture requiring hospitalization
* Failure of standard pain regimen as determined by RR \> 20, TV \< or equal to 50% predicted, NPS \> or equal to 5, Poor cough
Exclusion Criteria:
* age less than 18 years
* greater than 80 years
* GCS less than or equal to 13
* intubated at admission
* prior or anticipated exploratory laparotomy during this admission
* prior or expected thoracotomy during this admission
* prior or expected emergent craniotomy during this admission
* spinal cord injury
* pelvic injury that has required or will require operative intervention
* inability to accomplish activities of daily living independently
* pregnancy
* incarceration
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
Numeric Pain Score (NPS)
Timeframe: throughout patients' hospitalization time, an average of 1 week
2
Oral Morphine Equivalence (OME)
Timeframe: throughout patients' hospitalization time, an average of 1 week