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

Primary Purpose

Rib Fractures

Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine
Non steroidal anti-inflammatory drug and opioids
Sponsored by
Zachary Warriner
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rib Fractures focused on measuring intercostal, nerve block, opioid, non steroidal, inpatient, outpatient, catheter, anesthetic, epidural

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kentucky Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

continuous intercostal nerve block (CINB)

standard medical care

Arm Description

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

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

Outcomes

Primary Outcome Measures

Length of hospital stay
time from randomization until the time of discharge

Secondary Outcome Measures

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.
Modified Morphine Equivalent (MME) differences
Total morphine milligram equivalents (MME) will be assessed
hospital-free days
number of outpatient days for 1 month following randomization
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
mean respiratory rates
number of inspiratory cycles per minute taken each day until the patient is discharged
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."

Full Information

First Posted
November 29, 2022
Last Updated
September 19, 2023
Sponsor
Zachary Warriner
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1. Study Identification

Unique Protocol Identification Number
NCT05642026
Brief Title
INTERCOSTAL NERVE BLOCK: Efficacy of CINB for Patients With Multiple Rib Fractures
Official Title
The Efficacy of Continuous Intercostal Nerve Blocks in the Treatment of Patients With Multiple Rib Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zachary Warriner

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rib Fractures
Keywords
intercostal, nerve block, opioid, non steroidal, inpatient, outpatient, catheter, anesthetic, epidural

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
continuous intercostal nerve block (CINB)
Arm Type
Experimental
Arm Description
patients admitted to the adult trauma service with rib fractures who are receiving CINB
Arm Title
standard medical care
Arm Type
Active Comparator
Arm Description
patients admitted to the adult trauma service with rib fractures who are receiving standard medical care
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Naropin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Non steroidal anti-inflammatory drug and opioids
Intervention Description
Patients in this group receive nonsteroidal and opioid pain medications (intravenous/oral inpatient and oral outpatient) per standard of care.
Primary Outcome Measure Information:
Title
Length of hospital stay
Description
time from randomization until the time of discharge
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Patient daily pain scores
Description
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.
Time Frame
7 days
Title
Modified Morphine Equivalent (MME) differences
Description
Total morphine milligram equivalents (MME) will be assessed
Time Frame
7 days
Title
hospital-free days
Description
number of outpatient days for 1 month following randomization
Time Frame
30 days
Title
spirometry values
Description
measurements of inspiratory volume in milliliters will be taken pre-placement, 60 minutes after catheter insertion, the following day, and each subsequent morning
Time Frame
7 days
Title
mean respiratory rates
Description
number of inspiratory cycles per minute taken each day until the patient is discharged
Time Frame
7 days
Title
Patient reported quality of life
Description
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."
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zachary Warriner, MD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zachary D Warriner, MD
Phone
859-323-8222
Email
ZACHARYDWARRINER@UKY.EDU
First Name & Middle Initial & Last Name & Degree
zACHARY D WARRINER, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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