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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Rib Fractures
• Intervention / Treatment: Drug: Ropivacaine; Drug: Non steroidal anti-inflammatory drug and opioids

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Recruiting
      • University of Kentucky Medical Center
      • Principal Investigator: zACHARY D WARRINER, MD
      • Contact: Zachary D Warriner, MD; Phone Number: 8593238222; Email: ZACHARYDWARRINER@UKY.EDU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zachary Warriner
• Investigators: Principal Investigator: Zachary Warriner, MD, University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: November 29, 2022
• First Submitted That Met QC Criteria: November 29, 2022
• First Posted (Actual): December 8, 2022

Study Record Updates

• Last Update Posted (Estimated): October 7, 2025
• Last Update Submitted That Met QC Criteria: October 1, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: opioid; nerve block; outpatient; anesthetic; epidural; inpatient; intercostal; non steroidal; catheter
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Thoracic Injuries; Rib Fractures; Physiological Effects of Drugs; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Antirheumatic Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Narcotics; Organic Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Anilides; Amides; Aniline Compounds; Amines; Central Nervous System Agents; Ropivacaine; Analgesics, Opioid; Anti-Inflammatory Agents, Non-Steroidal
• Other Study ID Numbers: SURMI-22-INTERCOSTAL-NB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No