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

Rib Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05642026
• Other study ID #: SURMI-22-INTERCOSTAL-NB
• Status: Recruiting
• Phase: Phase 4
• Start date: June 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 31, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Rib Fractures

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Kentucky Medical Center	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Zachary Warriner

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospital stay	time from randomization until the time of discharge	7 days
Secondary	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
Secondary	Modified Morphine Equivalent (MME) differences	Total morphine milligram equivalents (MME) will be assessed	7 days
Secondary	hospital-free days	number of outpatient days for 1 month following randomization	30 days
Secondary	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
Secondary	mean respiratory rates	number of inspiratory cycles per minute taken each day until the patient is discharged	7 days
Secondary	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