CINB + Medical Therapy for Rib Fractures

Recruiting in Palo Alto (17 mi)

Overseen by Zachary Warriner, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Zachary Warriner

Disqualifiers: Allergy, Epidural use, Prisoners, others

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. It involves adding a new treatment (CINB) to standard medical care, which includes non-steroidal and opioid medications.

What data supports the effectiveness of the drug CINB + Medical Therapy for Rib Fractures?

Research shows that using a combination of different pain relief methods (multimodal analgesia) can reduce the need for opioids in patients with rib fractures, suggesting that combining treatments like Ropivacaine (a local anesthetic) with other pain management strategies may be effective. ^{1 2 3 4 5}

Is the treatment CINB + Medical Therapy for Rib Fractures safe for humans?

Nonsteroidal anti-inflammatory drugs (NSAIDs) like ketorolac and ropivacaine (Naropin) are generally used for pain relief, but they can have side effects such as increased bleeding risk and potential impact on bone healing. These risks are often dose-related and more common with prolonged use, so they need to be carefully assessed for each individual. ^{6 7 8 9 10}

How does the CINB + Medical Therapy treatment for rib fractures differ from other treatments?

The CINB (continuous intercostal nerve block) combined with medical therapy, including non-steroidal anti-inflammatory drugs and opioids, offers a unique approach by providing targeted pain relief directly to the nerves near the ribs, potentially reducing the need for systemic narcotics and minimizing side effects compared to traditional methods like epidural analgesia. ^{4 11 12 13 14}

Research Team

Zachary Warriner, MD

Principal Investigator

University of Kentucky

Eligibility Criteria

This trial is for adults over 18 with multiple rib fractures who agree to try a pain treatment involving nerve blocks. They must be willing to give informed consent. People can't join if they refuse the nerve block therapy, are allergic to the medication used in the study, already use an epidural catheter, or are prisoners.

Inclusion Criteria

I am 18 years old or older.

Subjects will have 2 or more identified rib fractures

Subjects will be willing to provide informed consent for procedure

Exclusion Criteria

Prisoners

I am using an epidural catheter.

Documented allergy to study medication

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive continuous intercostal nerve block (CINB) plus medical therapy or standard medical care for rib fractures

7 days

Daily monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including outpatient follow-up

30 days

Follow-up contact 2 days post-discharge

Treatment Details

Interventions

• Non steroidal anti-inflammatory drug and opioids (Analgesic)
• Ropivacaine (Local Anesthetic)

Trial Overview The study is testing whether adding continuous intercostal nerve block (CINB) to standard medical care (pain relief with non-steroidal anti-inflammatory drugs and opioids) provides better pain management for patients with rib fractures than standard care alone.

Participant Groups

Group I: continuous intercostal nerve block (CINB) Experimental Treatment 2 Interventions

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

Group II: standard medical care Active Control 1 Intervention

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Kentucky Medical Center Lexington, KY

Who Is Running the Clinical Trial?

Zachary Warriner

Lead Sponsor

Trials

1

Patients Recruited

180+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns and predictors of opioid prescribing and use after rib fractures. Dalton, MK., Chaudhary, MA., Andriotti, T., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketamine infusion for pain control in adult patients with multiple rib fractures: Results of a randomized control trial. Carver, TW., Kugler, NW., Juul, J., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture combined with multidisciplinary care for recovery after traumatic multiple rib fractures: a prospective feasibility cohort study. Kim, KH., Lee, CK., Cho, HM., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal analgesia reduces opioid requirements in trauma patients with rib fractures. Burton, SW., Riojas, C., Gesin, G., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnitude of rib fracture displacement predicts opioid requirements. Bugaev, N., Breeze, JL., Alhazmi, M., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of ketorolac is associated with decreased pneumonia following rib fractures. Yang, Y., Young, JB., Schermer, CR., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Postoperative use of nonsteroidal anti-inflammatory agents in orthopedic surgery]. Popović, NM., Karamarković, AR., Blagojević, ZB., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parecoxib for analgesia after craniotomy. Jones, SJ., Cormack, J., Murphy, MA., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of Nonunion with Nonselective NSAIDs, COX-2 Inhibitors, and Opioids. George, MD., Baker, JF., Leonard, CE., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NSAID Use and Effects on Pediatric Bone Healing: A Review of Current Literature. Choo, S., Nuelle, JAV.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative evaluation of continuous intercostal nerve block or epidural analgesia on the rate of respiratory complications, intensive care unit, and hospital stay following traumatic rib fractures: a retrospective review. Britt, T., Sturm, R., Ricardi, R., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of intercostal nerve block for management of pain in rib fracture patients. Hwang, EG., Lee, Y.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early intravenous ibuprofen decreases narcotic requirement and length of stay after traumatic rib fracture. Bayouth, L., Safcsak, K., Cheatham, ML., et al.[2013]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous intercostal nerve blockade for rib fractures: ready for primetime? Truitt, MS., Murry, J., Amos, J., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Patterns and predictors of opioid prescribing and use after rib fractures. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Ketamine infusion for pain control in adult patients with multiple rib fractures: Results of a randomized control trial. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Acupuncture combined with multidisciplinary care for recovery after traumatic multiple rib fractures: a prospective feasibility cohort study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Multimodal analgesia reduces opioid requirements in trauma patients with rib fractures. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Magnitude of rib fracture displacement predicts opioid requirements. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Use of ketorolac is associated with decreased pneumonia following rib fractures. [2021]

7. Serbia pubmed.ncbi.nlm.nih.gov

[Postoperative use of nonsteroidal anti-inflammatory agents in orthopedic surgery]. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Parecoxib for analgesia after craniotomy. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Risk of Nonunion with Nonselective NSAIDs, COX-2 Inhibitors, and Opioids. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

NSAID Use and Effects on Pediatric Bone Healing: A Review of Current Literature. [2021]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Comparative evaluation of continuous intercostal nerve block or epidural analgesia on the rate of respiratory complications, intensive care unit, and hospital stay following traumatic rib fractures: a retrospective review. [2020]

12. Korea (South) pubmed.ncbi.nlm.nih.gov

Effectiveness of intercostal nerve block for management of pain in rib fracture patients. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Early intravenous ibuprofen decreases narcotic requirement and length of stay after traumatic rib fracture. [2013]

14. United States pubmed.ncbi.nlm.nih.gov

Continuous intercostal nerve blockade for rib fractures: ready for primetime? [2022]