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Recruiting NCT05642026

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

Phase IV Interventional Rib Fractures

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ropivacaine, Non steroidal anti-inflammatory drug and opioids.
Who it may be relevant to
Registry conditions: Rib Fractures. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • 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.
  • 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.

Primary outcome measures

  • Length of hospital stay [Time frame: 7 days]
Secondary outcome measures (6)
  • Patient daily pain scores [Time frame: 7 days]
  • Modified Morphine Equivalent (MME) differences [Time frame: 7 days]
  • hospital-free days [Time frame: 30 days]
  • spirometry values [Time frame: 7 days]
  • mean respiratory rates [Time frame: 7 days]
  • Patient reported quality of life [Time frame: 7 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Kentucky Medical Center — Lexington

Identifiers

NCT: NCT05642026 · SURMI-22-INTERCOSTAL-NB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗