Rib FracturesPhase 4NCT05642026
INTERCOSTAL NERVE BLOCK: Efficacy of CINB for Patients With Multiple Rib Fractures
A Phase 4 study testing Ropivacaine and Non steroidal anti-inflammatory drug and opioids in people with Rib Fractures, run by Zachary Warriner at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rib Fractures
- What is being tested?
- Ropivacaine and Non steroidal anti-inflammatory drug and opioids
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2025to 1 Feb 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Documented allergy to study medication
- Epidural catheter use
- Prisoners
- Refusal of CINB therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kentucky Medical Center
Lexington, Kentucky, 40536
Zachary D Warriner, MD, 8593238222, ZACHARYDWARRINER@UKY.EDU
zACHARY D WARRINER, MD
About this study
Official title: The Efficacy of Continuous Intercostal Nerve Blocks in the Treatment of 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.
- Conditions
- Rib Fractures
- Being tested
- Ropivacaine, Non steroidal anti-inflammatory drug and opioids
- Keywords
- intercostal, nerve block, opioid, non steroidal, inpatient, outpatient, catheter, anesthetic, epidural
- Medical subject headings
- Rib Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called Naropin
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 opioidsDrug
Patients in this group receive nonsteroidal and opioid pain medications (intravenous/oral inpatient and oral outpatient) per standard of care.
| Study group | Role | What they receive |
|---|---|---|
| continuous intercostal nerve block (CINB) | Experimental | patients admitted to the adult trauma service with rib fractures who are receiving CINB Receives: 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 Receives: Drug: Non steroidal anti-inflammatory drug and opioids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
time from randomization until the time of discharge
Measured: 7 days
Secondary outcomes (6)
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.
Measured: 7 days
Modified Morphine Equivalent (MME) differences
Total morphine milligram equivalents (MME) will be assessed
Measured: 7 days
hospital-free days
number of outpatient days for 1 month following randomization
Measured: 30 days
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
Measured: 7 days
mean respiratory rates
number of inspiratory cycles per minute taken each day until the patient is discharged
Measured: 7 days
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."
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start23 Sep 2025
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rib FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zachary Warriner
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zachary Warriner, University of Kentucky
- Investigators
- Zachary Warriner, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642026
- Sponsor's protocol ID
- SURMI-22-INTERCOSTAL-NB
- Status last verified
- Oct 2026
- First submitted
- 29 Nov 2022
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Continuous Intercostal Nerve Blocks in the Treatment of Patients With Multiple Rib Fractures
- ClinicalTrials.gov ID
- NCT05642026
- Acronym / sponsor ID
- SURMI-22-INTERCOSTAL-NB
- Conditions
- Rib Fractures
- Keywords
- intercostal, nerve block, opioid, non steroidal, inpatient, outpatient, catheter, anesthetic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Zachary WarrinerUniversity, hospital or other
- Study start
- 23 Sep 2025 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| continuous intercostal nerve block (CINB) | Experimental | Drug: Ropivacaine, Drug: Non steroidal anti-inflammatory drug and opioidspatients admitted to the adult trauma service with rib fractures who are receiving CINB |
| standard medical care | Active comparator | Drug: Non steroidal anti-inflammatory drug and opioidspatients admitted to the adult trauma service with rib fractures who are receiving standard medical care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Documented allergy to study medication
- Epidural catheter use
- Prisoners
- Refusal of CINB therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RopivacaineAlso: NaropinPatients 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. | Drug | continuous intercostal nerve block (CINB) |
| Non steroidal anti-inflammatory drug and opioidsPatients in this group receive nonsteroidal and opioid pain medications (intravenous/oral inpatient and oral outpatient) per standard of care. | Drug | continuous intercostal nerve block (CINB), standard medical care |
Primary outcome
Length of hospital stay
Time frame: 7 days
time from randomization until the time of discharge
6 secondary outcomes
Patient daily pain scores
Time frame: 7 days
Modified Morphine Equivalent (MME) differences
Time frame: 7 days
hospital-free days
Time frame: 30 days
spirometry values
Time frame: 7 days
mean respiratory rates
Time frame: 7 days
Patient reported quality of life
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zachary Warriner, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine and Non steroidal anti-inflammatory drug and opioids in people with Rib Fractures, run by Zachary Warriner at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.