Cryoablation for Rib Fractures

Overseen By Bradely W Thomas, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Flail chest, Brain injury, Spinal cord, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: During hospital admission

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding cryoablation, a technique using extreme cold to reduce pain, helps patients with multiple rib fractures experience less pain compared to standard surgical treatment alone. The research compares two groups: one receiving cryoablation in addition to regular surgery and pain therapy, and another receiving only surgery and pain therapy without cryoablation. Suitable candidates for this trial include those admitted with two or more displaced rib fractures who are not experiencing chronic pain.

As an unphased trial, this study provides patients the opportunity to explore innovative pain management options beyond standard care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that cryoablation for rib fractures is safe?

Research has shown that cryoablation, a procedure using extreme cold to numb nerves, is generally safe for individuals with broken ribs. In one study, researchers performed 135 cryoablation procedures on 20 patients, demonstrating its safety and practicality. Another study found that patients undergoing cryoablation during rib surgery spent less time in intensive care and experienced fewer hospital complications compared to those who did not. Overall, cryoablation is considered a safe and effective method to reduce pain from rib fractures when used alongside standard surgical treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about cryoablation for rib fractures because it offers a novel approach to pain management in patients with multiple rib fractures. Unlike the standard treatment, which typically involves surgical stabilization and multimodal pain therapy, cryoablation uses extreme cold to numb the nerves around the fractured ribs, potentially reducing pain more effectively and quickly. This technique could lead to better pain control, faster recovery times, and reduced reliance on opioid medications, which is a significant advantage over current methods.

What evidence suggests that cryoablation of intercostal nerves is effective for rib fracture pain relief?

Research has shown that cryoablation, a technique that freezes nerves to reduce pain, can effectively manage pain in patients with rib fractures. In this trial, one group of participants will receive Surgical Stabilization of Rib Fractures plus Multimodal Pain Therapy, with the addition of cryoablation. Studies have found that using cryoablation during rib fracture surgery controls pain better than surgery without it. Patients who underwent cryoablation reported less pain and required fewer pain medications. This suggests that cryoablation may improve comfort and recovery for individuals with multiple rib fractures. ^{2 3 4 6 7}

Who Is on the Research Team?

Bradely W. Thomas, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have been admitted with multiple displaced rib fractures and are set to undergo surgical stabilization within 72 hours of injury. It's not for those under 18 or over 79, with severe brain injuries, spinal cord injuries, certain chest conditions like flail chest, major surgeries during this admission, inability to live independently before the injury, prisoners, pregnant women or if unable to perform VATS.

Inclusion Criteria

The patient is admitted to the trauma service

I am not receiving treatment for chronic pain.

I am older than 18 years.

Exclusion Criteria

The patient is incarcerated

I have had or am expected to have emergency brain surgery during this hospital stay.

I have had or am expected to have emergency abdominal surgery during this hospital stay.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Surgical Stabilization of Rib Fractures with or without cryoablation

During hospital admission

In-hospital procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment, including quality of life assessments and opioid use

3 months

Monthly assessments

Long-term follow-up

Participants are monitored for additional thoracic procedures and readmissions

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Cryoablation of Intercostal Nerves
• Standard surgical treatment of patients with multiple rib fractures

Trial Overview The study is testing whether using cryoablation (a technique that freezes nerves) along with standard surgery for broken ribs can provide better pain relief than surgery alone. Participants will be randomly assigned to either receive cryoablation plus surgery or just the surgery.

How Is the Trial Designed?

Group I: Surgical Stabilization of Rib Fractures plus Multimodal Pain Therapy plus CRYOABLATION Experimental Treatment 1 Intervention

Adding Cryoablation of levels 3-8, in addition to patients that undergo SSRF for multiple rib fractures.

Group II: Surgical Stabilization of Rib Fractures plus Multimodal Pain Therapy Active Control 1 Intervention

Standard surgical treatment of patients with multiple rib fractures plus Multimodal Pain Therapy

Standard surgical treatment of patients with multiple rib fractures is already approved in United States, European Union for the following indications:

Approved in United States as Surgical Stabilization of Rib Fractures for:

• Flail chest
• Unstable chest wall injury
• Severe thoracic injuries

Approved in European Union as Surgical Stabilization of Rib Fractures for:

• Flail chest
• Unstable chest wall injury
• Multiple rib fractures

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

In a study of 277 trauma patients, surgical stabilization of rib fractures (SSRF) did not show overall benefits for hospital course or complications, but it significantly helped patients with lower Glasgow Coma Scale (GCS) scores, indicating severe brain injury.

Patients with reduced GCS who underwent SSRF experienced shorter ICU stays and less time on respirators, suggesting that SSRF can improve outcomes in those with both rib fractures and moderate to severe brain injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical stabilization of serial rib fractures is advantageous in patients with relevant traumatic brain injury. Freitag, P., Bechmann, C., Eden, L., et al.[2022]

In a study of 203,450 patients with multiple rib fractures, those who underwent surgical stabilization of rib fractures (SSRF) had a higher rate of home discharge (62%) compared to those managed nonoperatively (58%).

Patients treated with SSRF also experienced lower rates of lung-related readmissions at both 3 months (3.1% vs. 4.0%) and 12 months (6.2% vs. 7.6%) compared to nonoperative management, indicating better long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of surgical versus nonsurgical treatment for multiple rib fractures: A US hospital matched cohort database analysis. Shiroff, AM., Wolf, S., Wu, A., et al.[2023]

A study involving 61 Dutch healthcare professionals identified 16 barriers and 2 facilitators to the use of surgical stabilization of rib fractures (SSRF) for multiple rib fractures, highlighting a lack of knowledge and experience as significant obstacles.

The findings suggest that improving clinical knowledge and providing high-level evidence on the effectiveness and cost-effectiveness of SSRF could enhance its acceptance and implementation among healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rib Fixation for Multiple Rib Fractures: Healthcare Professionals Perceived Barriers and Facilitators to Clinical Implementation. Spronk, I., Van Wijck, SFM., Van Lieshout, EMM., et al.[2023]

In a study of 112 patients undergoing surgical stabilization of rib fractures (SSRF), those who received the intrathoracic technique required significantly less opioid medication (21.25 MME) compared to those who had the extrathoracic technique (46.20 MME) at 7-day follow-up, indicating better pain control.

The study suggests that the intrathoracic SSRF technique may be more effective for managing postoperative pain, supporting its use over the extrathoracic approach in similar surgical cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intrathoracic plates versus extrathoracic plates: a comparison of postoperative pain in surgical stabilization of rib fracture technique. Tichenor, M., Reparaz, LB., Watson, C., et al.[2023]

In a study of 122 patients who underwent surgical stabilization of rib fractures (SSRF), only 4.1% developed hardware infections, indicating that while infections are uncommon, they can lead to significant complications.

An aggressive multimodal management strategy for hardware infections, including wound debridement and hardware removal, resulted in successful bony union and favorable long-term outcomes for all patients, highlighting the importance of effective treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infected hardware after surgical stabilization of rib fractures: Outcomes and management experience. Thiels, CA., Aho, JM., Naik, ND., et al.[2018]

Surgical stabilization of rib fractures (SSRF) in severely injured patients significantly reduces mortality rates (3.3% vs. 7.6% for non-surgical treatment), based on a study of 483 patients from a multi-center database.

However, SSRF is associated with longer ventilation times and extended stays in both the intensive care unit and overall hospital, indicating a trade-off between reduced mortality and increased resource use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of surgical stabilization of rib fractures in polytrauma: an analysis of the TraumaRegister DGU®. Becker, L., Schulz-Drost, S., Spering, C., et al.[2022]

Intercostal nerve cryoablation (IC) during surgical stabilization of rib fractures (SSRF) was found to be safe and feasible, with no significant immediate or long-term complications reported among the 20 patients who underwent the procedure.

While the study did not show a significant reduction in pain scores or opioid use for the SSRF-IC group compared to the SSRF group, further research is needed to fully evaluate the analgesic efficacy of IC for rib fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intercostal nerve cryoablation during surgical stabilization of rib fractures. Choi, J., Min, JG., Jopling, JK., et al.[2023]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0022480424005328

Inpatient Outcomes of Intercostal Nerve Cryoablation With ... ... stabilization of rib fractures (SSRF) after injury. However, data on INCA ... Intercostal nerve cryoablation for control of traumatic rib fracture pain: a case ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34446656/

Intercostal nerve cryoablation during surgical stabilization ... We hypothesized that concurrent surgical stabilization of rib fractures and intercostal nerve cryoablation ... Fracture Fixation / adverse effects ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020138323004436

Intercostal nerve cryoablation during surgical stabilization ... The purpose of this study was to analyze our experience with cryoablation in patients undergoing SSRF after traumatic chest wall injury. ... rib fracture patient.

4. ccts.amegroups.org ccts.amegroups.org/article/view/104585/html

Role of intercostal nerve block and cryoneurolysis in the ... Effectiveness of intercostal nerve block for management of pain in rib fracture patients. J Exerc Rehabil 2014;10:241-4. [Crossref] [PubMed]; Mahmoudi K ...

5. journals.lww.com journals.lww.com/joct/fulltext/2019/04010/a_multi_institution_case_series_of_intercostal.8.aspx

A Multi-institution Case Series of Intercostal Nerve... The median age was 58 (35–77) and all injuries were caused by blunt mechanism. Median number of ribs fractured was 7 (4–11). Mean time to operation was 2.1 ± ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11750013/

Rib fracture management: A review of surgical stabilization ... In addition, intercostal nerve cryoablation has emerged as a safe and effective adjunct to SSRF, providing additional rib fracture pain relief for a period ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04482582

Early Percutaneous Cryoablation for Pain Control After Rib ... The purpose of this study is to provide long-term pain control for elderly patients with rib fractures in order to minimize their risk of complications and ...