INTERCOSTAL NERVE BLOCK: Efficacy of CINB for Patients With Multiple Rib Fractures

Study Overview
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Brief Summary
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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.

Official Title
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The Efficacy of Continuous Intercostal Nerve Blocks in the Treatment of Patients With Multiple Rib Fractures

Conditions
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Rib Fractures

Intervention / Treatment
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* Drug: Ropivacaine
* Drug: Non steroidal anti-inflammatory drug and opioids


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: continuous intercostal nerve block (CINB)<br>patients admitted to the adult trauma service with rib fractures who are receiving CINB | Drug: Ropivacaine<br>* 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.<br>* Other names: Naropin;Drug: Non steroidal anti-inflammatory drug and opioids<br>* Patients in this group receive nonsteroidal and opioid pain medications (intravenous/oral inpatient and oral outpatient) per standard of care.<br>|
| Active Comparator: standard medical care<br>patients admitted to the adult trauma service with rib fractures who are receiving standard medical care | Drug: Non steroidal anti-inflammatory drug and opioids<br>* Patients in this group receive nonsteroidal and opioid pain medications (intravenous/oral inpatient and oral outpatient) per standard of care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | time from randomization until the time of discharge | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient daily pain scores | 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. | 7 days | 
| Modified Morphine Equivalent (MME) differences | Total morphine milligram equivalents (MME) will be assessed | 7 days | 
| hospital-free days | number of outpatient days for 1 month following randomization | 30 days | 
| spirometry values | measurements of inspiratory volume in milliliters will be taken pre-placement, 60 minutes after catheter insertion, the following day, and each subsequent morning | 7 days | 
| mean respiratory rates | number of inspiratory cycles per minute taken each day until the patient is discharged | 7 days | 
| Patient reported quality of life | 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. | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioid, inpatient, outpatient, catheter, anesthetic, epidural, intercostal, nerve block, non steroidal