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

NCT05642026 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: SURMI-22-INTERCOSTAL-NB
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Rib Fractures

Keywords

intercostal; nerve block; opioid; non steroidal; inpatient; outpatient; catheter; anesthetic; epidural

Outcome Measures

Primary Outcomes (1)

• Length of hospital stay

  time from randomization until the time of discharge

  7 days

Secondary Outcomes (6)

• Patient daily pain scores

  7 days

• Modified Morphine Equivalent (MME) differences

  7 days

• hospital-free days

  30 days

• spirometry values

  7 days

• mean respiratory rates

  7 days

Study Arms (2)

continuous intercostal nerve block (CINB)

EXPERIMENTAL

patients admitted to the adult trauma service with rib fractures who are receiving CINB

Drug: Ropivacaine; Drug: Non steroidal anti-inflammatory drug and opioids

standard medical care

ACTIVE COMPARATOR

patients admitted to the adult trauma service with rib fractures who are receiving standard medical care

Drug: Non steroidal anti-inflammatory drug and opioids

Interventions

Ropivacaine DRUG

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.

Also known as: Naropin

continuous intercostal nerve block (CINB)

Non steroidal anti-inflammatory drug and opioids DRUG

Patients in this group receive nonsteroidal and opioid pain medications (intravenous/oral inpatient and oral outpatient) per standard of care.

continuous intercostal nerve block (CINB); standard medical care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Documented allergy to study medication
• Epidural catheter use
• Prisoners
• Refusal of CINB therapy

Sponsors & Collaborators

• Zachary Warriner: lead

Study Sites (1)

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

RECRUITING

MeSH Terms

Conditions

Rib Fractures

Interventions

Ropivacaine; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Opioid

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Narcotics; Central Nervous System Depressants; Central Nervous System Agents

Study Officials

• Zachary Warriner, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 8, 2022
• Study Start: September 23, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: October 7, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)