Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts 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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
continuous intercostal nerve block (CINB) 		patients admitted to the adult trauma service with rib fractures who are receiving CINB
  • Drug: Ropivacaine
    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.
    Other names:
    • Naropin
  • Drug: Non 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.
Active Comparator
standard medical care 		patients admitted to the adult trauma service with rib fractures who are receiving standard medical care
  • Drug: Non 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.

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky Medical Center
Lexington, Kentucky 40536
Contact:
Zachary D Warriner, MD
859-323-8222
ZACHARYDWARRINER@UKY.EDU

More Details

NCT ID
NCT05642026
Status
Recruiting
Sponsor
Zachary Warriner

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.