CINB + Medical Therapy for Rib Fractures

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Zachary Warriner

Disqualifiers: Allergy, Epidural use, Prisoners, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 7 days

180 Participants Needed

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

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
• Ropivacaine

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

Who Is Running the Clinical Trial?

Zachary Warriner

Lead Sponsor

Trials

1

Recruited

180+

Findings from Research

In a study of 29,943 adult patients with rib fractures, only 9% were prescribed opioids, with those having prior opioid exposure using them for a median of 36 days compared to 16 days for opioid-naïve patients.

Prior opioid exposure was identified as the strongest predictor of continued opioid use after rib fractures, while the severity of the injury (number of ribs fractured) did not influence the duration of opioid use.

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]

In a study of 91 trauma patients with three or more rib fractures, low-dose ketamine did not significantly reduce pain scores or opioid use in the overall group, indicating it may not be effective as a primary analgesic for all patients.

However, among severely injured patients (Injury Severity Score >15), low-dose ketamine significantly reduced opioid consumption during the first 48 hours, suggesting it could be beneficial for this specific subgroup.

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]

In a study of 20 patients with traumatic multiple rib fractures, combining acupuncture with multidisciplinary care significantly reduced the number of patients experiencing above-moderate pain from 95% at baseline to 41% after 6 months.

The majority of patients (80%) reported satisfaction with acupuncture treatments, and over 94% noted some improvement, suggesting that acupuncture may be a beneficial adjunct therapy during recovery, although further randomized trials are needed.

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]

The implementation of a multimodal pain regimen (MMPR) for adult trauma patients with rib fractures led to a significant reduction in daily opioid use during hospitalization, decreasing from an average of 23 morphine milligram equivalents (MME) to 17 MME over the first five days.

Patients discharged after the MMPR had a notable decrease in outpatient opioid prescriptions, with the total prescribed amount dropping from 322 MME to 225 MME, indicating a more effective pain management strategy that reduces reliance on opioids.

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]

In a study of 245 blunt rib fracture patients, both the magnitude of rib fracture displacement and the number of fractures were found to significantly predict the amount of opioid pain medication required, with every 5-mm increase in displacement leading to a 6.3% increase in opioid needs.

Patients with combined displaced and nondisplaced rib fractures had higher injury severity scores and required more opioids compared to those with only displaced or nondisplaced fractures, indicating that more severe injuries correlate with greater pain management needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

In a study of 619 patients with rib fractures, those who received ketorolac within 4 days of injury had a significantly lower risk of developing pneumonia, with an odds ratio of 0.14, indicating a strong protective effect.

Ketorolac treatment also resulted in more ventilator-free days and intensive care unit-free days, suggesting improved recovery without increasing the risk of adverse effects like kidney injury or gastrointestinal issues.

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]

NSAIDs provide effective pain relief and anti-inflammatory effects, which can help reduce the need for opioids after surgery, but their use carries risks of systemic adverse effects, especially with prolonged exposure.

While Coxibs may lower the risk of gastrointestinal bleeding associated with traditional NSAIDs, they can increase cardiovascular risks, and NSAIDs can also moderately increase bleeding time, necessitating careful assessment in patients with coagulopathy or those on anticoagulants.

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]

In a study of 82 patients undergoing elective craniotomies, a single dose of parecoxib (40 mg) given at dural closure showed a reduction in pain scores at 6 hours and decreased morphine use at 6 and 12 hours post-surgery.

Despite these findings, parecoxib had only a minimal overall impact on postoperative analgesia, indicating limited effectiveness as a pain management option after craniotomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

In a study of 339,864 fracture episodes, COX-2 inhibitors were found to significantly increase the risk of nonunion after long-bone fractures, with an adjusted odds ratio of 1.84, indicating more than a 80% higher risk compared to those not using these medications.

Opioid prescriptions were also associated with a higher risk of nonunion (odds ratio of 1.69), suggesting that while they may be used for pain management, they could complicate healing, especially in patients with more severe fractures.

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]

Non-steroidal anti-inflammatory drugs (NSAIDs) can be safely used in skeletally immature patients for pain control during fracture healing without increasing the risk of nonunion, especially in long bone fractures and pseudoarthrosis after spine fusion.

Further clinical studies are necessary to determine the best types, dosages, and duration of NSAID use to optimize bone healing in young patients.

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]

In a study of patients with traumatic rib fractures, continuous intercostal nerve blockade (CINB) resulted in a lower rate of pneumonia or respiratory failure (12.5%) compared to epidural analgesia (16.3%), but this difference was not statistically significant (P=0.58).

CINB was associated with a significant reduction in hospital stay (6.98 days) compared to epidural analgesia (9.72 days), suggesting that CINB may lead to quicker recovery and fewer complications, although further research is needed to confirm these findings.

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]

Intercostal nerve block (ICNB) provides significant immediate pain relief for patients with fractured ribs, as shown by a retrospective analysis of medical records, but its effectiveness diminishes over time.

For sustained pain management, especially in patients whose pain levels rise after ICNB, additional methods like intravenous patient-controlled analgesia or fentanyl patches are recommended to prevent complications and chronic pain.

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]

In a study of 42 patients with traumatic rib fractures, those treated with intravenous ibuprofen (IVIb) alongside narcotics required significantly less narcotic medication, with a daily morphine-equivalent reduction from 32 mg to 19 mg (P < 0.0001).

Patients receiving IVIb also reported lower pain scores and had a shorter hospital stay (4.4 days vs. 5.4 days), indicating that IVIb therapy can enhance pain management and reduce reliance on narcotics without significant complications.

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]

The study of 102 adult patients with rib fractures showed that continuous intercostal nerve block (CINB) significantly improved pain control, with pain scores dropping from an average of 7.5 to 2.6 at rest after treatment.

CINB also enhanced pulmonary function, as indicated by increased lung volumes and a reduced need for mechanical ventilation, while shortening the average hospital stay from 5.9 days to 2.9 days without any reported complications.

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]