Rib Fractures
Conditions
Keywords
intercostal, nerve block, opioid, non steroidal, inpatient, outpatient, catheter, anesthetic, epidural
Brief summary
This is a prospective, randomized, non-blinded study comparing CINB plus medical therapy versus standard medical care (non-steroidals and opioids intravenous/oral inpatient and oral outpatient) alone for patients with multiple rib fractures. The objective of this study is to analyze the effect of continuous intercostal nerve block (CINB) in the treatment of patients admitted to the adult trauma service with rib fractures. The effectiveness of CINB as adjunctive treatment will be compared to standard medical therapy involving nonsteroidal and intravenous/oral opioid medications.
Interventions
DRUGRopivacaine
Patients in this group will receive CINB (continuous local intercostal infusion of 0.2% Ropivacaine). A single catheter will be placed for short segment involvement and two catheters will be placed in series for longer segments of involvement. If necessary and as part of standard of care, CINB treatment will continue after patient discharge. The administration of CINB therapy will continue in the same manner as inpatient therapy.
DRUGNon steroidal anti-inflammatory drug and opioids
Patients in this group receive nonsteroidal and opioid pain medications (intravenous/oral inpatient and oral outpatient) per standard of care.
Sponsors
Zachary Warriner
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects will be at least 18 years old * Subjects will have 2 or more identified rib fractures * Subjects will be willing to provide informed consent for procedure * Subjects will be identified as appropriate for initiation of continuous nerve block therapy for treatment of rib fracture associated pain.
Exclusion criteria
* Documented allergy to study medication * Epidural catheter use * Prisoners * Refusal of CINB therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | 7 days | time from randomization until the time of discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Morphine Equivalent (MME) differences | 7 days | Total morphine milligram equivalents (MME) will be assessed |
| hospital-free days | 30 days | number of outpatient days for 1 month following randomization |
| Patient daily pain scores | 7 days | Pain will be assessed using a 10-Point Numerical Pain Scale (as part of standard of care) every day while patient is hospitalized and 2 days following discharge at follow contact. Scores range from 0-10; higher scores indicated higher levels of pain. |
| mean respiratory rates | 7 days | number of inspiratory cycles per minute taken each day until the patient is discharged |
| Patient reported quality of life | 7 days | Patient reported quality of life will be measured through the EuroQol instrument (EQ-5D-5L). The EuroQol 5 Dimension 5 Level (EQ-5D-5L) is a self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking that ranges from no problems through extreme problems. |
| spirometry values | 7 days | measurements of inspiratory volume in milliliters will be taken pre-placement, 60 minutes after catheter insertion, the following day, and each subsequent morning |
Countries
United States
Outcome results
None listed