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

Phase 4

Recruiting

• Conditions: Rib Fractures
• Interventions: Drug: Ropivacaine; Drug: Non steroidal anti-inflammatory drug and opioids

• Registration Number: NCT05642026
• Lead Sponsor: Zachary Warriner

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-29
• Study First Submitted QC: 2022-11-29
• Study First Posted: 2022-12-08
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-03-28
• Study Start: 2025-09
• Primary Completion: 2026-02-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
continuous intercostal nerve block (CINB)	Non steroidal anti-inflammatory drug and opioids	patients admitted to the adult trauma service with rib fractures who are receiving CINB
standard medical care	Non steroidal anti-inflammatory drug and opioids	patients admitted to the adult trauma service with rib fractures who are receiving standard medical care
continuous intercostal nerve block (CINB)	Ropivacaine	patients admitted to the adult trauma service with rib fractures who are receiving CINB

Primary Outcome Measures

Name	Time	Method
Length of hospital stay	7 days	time from randomization until the time of discharge

Secondary Outcome Measures

Name	Time	Method
Patient reported quality of life	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."
Patient daily pain scores	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.
Modified Morphine Equivalent (MME) differences	7 days	Total morphine milligram equivalents (MME) will be assessed
spirometry values	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
mean respiratory rates	7 days	number of inspiratory cycles per minute taken each day until the patient is discharged
hospital-free days	30 days	number of outpatient days for 1 month following randomization

Trial Locations

Locations (1)

University of Kentucky Medical Center; 🇺🇸 Lexington, Kentucky, United States