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NCT Number: NCT05642026

INTERCOSTAL NERVE BLOCK: Efficacy of CINB for 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.

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Key information

Conditions

Rib Fractures Fractures, Bone Thoracic Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Location status: Recruiting

Location contact

Zachary D Warriner, MD

CONTACT

[email protected]

8593238222

zACHARY D WARRINER, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Naropin

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.

Primary outcomes

  1. Length of hospital stay

    Time frame: 7 days

    time from randomization until the time of discharge

Secondary outcomes

  1. Patient daily pain scores

    Time frame: 7 days

    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.

  2. Modified Morphine Equivalent (MME) differences

    Time frame: 7 days

    Total morphine milligram equivalents (MME) will be assessed

  3. hospital-free days

    Time frame: 30 days

    number of outpatient days for 1 month following randomization

  4. spirometry values

    Time frame: 7 days

    measurements of inspiratory volume in milliliters will be taken pre-placement, 60 minutes after catheter insertion, the following day, and each subsequent morning

  5. mean respiratory rates

    Time frame: 7 days

    number of inspiratory cycles per minute taken each day until the patient is discharged

  6. Patient reported quality of life

    Time frame: 7 days

    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."

Sponsors and collaborators

Lead sponsor

Zachary Warriner

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 8, 2022
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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