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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment approach for individuals with multiple rib fractures. Researchers aim to determine if adding a continuous intercostal nerve block (CINB), which blocks pain signals, can enhance pain management compared to standard treatments like non-steroidal anti-inflammatory drugs and opioids. The goal is to assess whether this provides additional relief for patients admitted with rib fractures. Suitable candidates for this trial include those with two or more rib fractures who are willing to try CINB for pain relief. As a Phase 4 trial, this research involves an FDA-approved treatment and seeks to understand how it can benefit more patients.

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 is the safety track record for these treatments?

Research shows that continuous intercostal nerve block (CINB) is generally well-tolerated by patients with broken ribs. Studies indicate that CINB significantly improves pain relief and shortens hospital stays. These studies report no serious side effects, suggesting CINB is safe to use.

The treatment uses ropivacaine, a type of local anesthetic. In studies comparing different pain relief methods, ropivacaine effectively reduced pain without causing serious side effects. While all treatments carry risks, evidence suggests that CINB with ropivacaine is a safe option for managing pain from rib fractures. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about continuous intercostal nerve block (CINB) for rib fractures because it offers a targeted pain relief approach that differs from standard care options like NSAIDs and opioids. Unlike these medications, which work systemically and can have widespread side effects, CINB delivers pain relief directly to the nerves around the fractured ribs. This localized method not only potentially provides more effective pain control but also reduces the risk of side effects associated with opioid use, such as dependency and sedation. By focusing directly on the site of injury, CINB aims to improve patient comfort and recovery times.

What evidence suggests that CINB plus medical therapy is effective for rib fractures?

This trial will compare continuous intercostal nerve block (CINB) with standard medical care for patients with rib fractures. Research has shown that CINB can significantly aid individuals with broken ribs. Studies have found that CINB provides superior pain relief and improves lung function, potentially leading to faster recovery. One study even found that CINB shortened hospital stays for these patients. While this trial compares CINB to standard treatments like non-steroidal drugs and opioids, evidence suggests that adding CINB offers better pain control than medication alone. Overall, CINB can effectively manage pain from rib fractures. ^{1 6 7 8 9}

Who Is on the Research Team?

Zachary Warriner, MD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

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

Subjects will have 2 or more identified rib fractures

Subjects will be willing to provide informed consent for procedure

I am identified as a candidate for nerve block therapy for my rib fracture pain.

Exclusion Criteria

Prisoners

I am using an epidural catheter.

Documented allergy to study medication

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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]

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 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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6689037/

Comparison of analgesic interventions for traumatic rib fractures Results of this study show that epidural analgesia provides better pain relief than the other modalities.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22182865/

Continuous intercostal nerve blockade for rib fractures Utilization of CINB significantly improved pulmonary function, pain control, and shortens LOS in patients with rib fractures.

3. academic.oup.com academic.oup.com/painmedicine/article/18/9/1787/2924763

Improved Outcomes Associated with the Liberal Use of ... Controlling for age, injury severity, and use of mechanical ventilation, epidural analgesia predicted a 97% reduction in mortality. Conclusion.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2352644022000760

Single injection, ultrasound-guided planar nerve blocks: An ... A 2019 review of the U.S. National Trauma Data Bank showed that of patients with more than 3 rib fractures only 3 % received epidural analgesia and fewer still ...

5. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2818238

Serratus Anterior Plane Blocks for Early Rib Fracture Pain ... Patients met the primary outcome if they had a pain score reduction of 2 or more points and an absolute pain score of less than 4 out of 10 ...

6. withpower.com withpower.com/trial/phase-4-fractures-bone-11-2022-5d6d8

CINB + Medical Therapy for Rib Fractures The study of 102 adult patients with rib fractures showed that continuous intercostal nerve block (CINB) significantly improved pain control, with pain ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05642026/intercostal-nerve-block-efficacy-of-cinb-for-patients-with-multiple-rib-fractures

Efficacy of CINB 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 ...

8. clinicaltrial.be clinicaltrial.be/en/details/174042?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

INTERCOSTAL NERVE BLOCK: Efficacy of CINB for ... The objective of this study is to analyze the effect of continuous intercostal nerve block (CINB) in the treatment of patients admitted to the ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8908443/

Comparison of Intercostal Nerve Block with Ropivacaine and ... Results. The intercostal block significantly reduced pain in both groups (P < 0.0001). The pain was lower in the RD group than in the R group ...