Status:
UNKNOWN
Optimal Method of Pain Management in Patients With Multiple Rib Fractures
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
I-Flow
Conditions:
3 or More Rib Fractures
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age ≥ 18 years;
- Three or more rib fractures;
- Pain
- Severe pain (i.e. causing deleterious affect on respiratory mechanics, respiratory rate, or oxygen saturations), OR
- Mild to moderate pain (i.e. minimally affecting respiratory mechanics, respiratory rate, or oxygen saturations) that does not respond to oral or intravenous analgesics within 4 hours;
- Patient has capacity to provide informed consent, as determined by:
- Clinical assessment by study staff MD who will explain the study to potential subjects and then ask them to summarize the purpose, procedures, risks and alternatives back to the MD;
- GCS 15;
- Clinical assessment by independent MD who will explain the study to potential subjects and then ask them to summarize the purpose, procedures, risks and alternatives back to the MD.
- Exclusion criteria:
- Lack capacity to provide informed consent;
- Intubation at time of enrollment;
- Contraindications to procedure (e.g. known allergy to local anesthetics).
- Presence of infection at site of catheter placement;
- Current use of anticoagulant medication;
- Known allergy to silver;
- Inability to obtain informed consent;
- Body weight \> 300 lbs;
- Pregnancy;
- Significant co-morbid medical illness that might alter the metabolism of the anesthetic agents and result in unexpected toxicity (hepatic, renal or cardiopulmonary disease).
- All women of child-bearing age will receive a urine pregnancy test prior to the start of the interventional portion of the study. A positive test result excludes the patient from inclusion in the study.
Exclusion
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2014
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT01401712
Start Date
October 1 2012
End Date
October 1 2014
Last Update
October 29 2013
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114