CompletedPhase 2

Intercostal Liposomal Bupivacaine for the Management of Blunt Chest Wall Trauma

United States100 participantsStarted 2018-03-09

Plain-language summary

This is a study of liposomal bupivacaine for pain control in patients with blunt chest wall trauma.

Who can participate

Age range

18 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: * Anticipated length of stay of at least 72 hours * Blunt chest wall trauma with two or more rib or sternal fractures * Demonstrated ability to achieve \> 50% predicted inspiratory capacity based on ideal body weight using IS within the first 24 hours of admission Exclusion Criteria: * Known allergy to bupivacaine * Respiratory failure requiring intubation within 24 hours prior to enrollment * Known or suspected atrioventricular nodal blockade process requiring cardiology evaluation or pacemaker placement * Hemodynamic instability (defined as new intravenous vasopressor or inotrope requirement or mean arterial pressure \< 55 mmHg) * Signs of active myocardial ischemia or non-ST elevation MI * \> 20 rib fractures * Weight \< 50 kg or \> 150 kg * 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

Opioid Requirement at 24 Hours Post-randomization

Timeframe: 24 hours following randomization.

Opioid Requirement at 48 Hours Post-randomization.

Timeframe: 48 hours following randomization.

Opioid Requirement at 72 Hours Post-randomization

Timeframe: 72 hours following randomization.

Opioid Requirement at 96 Hours Post-randomization

Timeframe: 96 hours following randomization.

Trial details

NCT IDNCT02749968

SponsorUniversity of Cincinnati

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-01-01

Results submitted2022-02-14

View on ClinicalTrials.gov More Blunt Chest Wall Trauma trials