Cryoablation for Postoperative Pain

Overseen By Shari L Barnett

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Pregnancy, Cognitive impairment, Psychological disorders, 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: 2

Duration: Approximately 3 days

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if cryoablation, a method that freezes and destroys tissue to ease pain, manages post-surgical pain more effectively than usual methods like epidural or intercostal nerve blocks. It focuses on patients undergoing specific types of chest surgery who have not previously used opioids. This study suits those scheduled for elective thoracic surgery at Michigan Medicine, with no history of chest surgery, fibromyalgia, or psychological issues. As an unphased trial, it offers patients the opportunity to contribute to innovative pain management research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that participants must be opioid naïve, meaning they should not have used opioids before.

What prior data suggests that cryoablation is safe for postoperative pain control?

Research has shown that cryoablation is generally safe and can help reduce pain. Several studies have found it effective in managing pain with a good safety record. For example, one study found it effective in controlling pain for conditions like endometriosis, with few complications. Another study noted its safety for patients who have undergone certain cancer treatments.

However, some risks exist. One study found that patients with a specific medical device (a ureteral stent) experienced more complications after cryoablation. Additionally, some patients might not report all their symptoms, potentially hiding issues.

Overall, cryoablation appears well-tolerated by many patients, but discussing any concerns with the research team is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Cryoablation is unique because it uses a cryosphere device to emit a freezing gas, effectively freezing and destroying tissue cells to manage postoperative pain. Unlike standard intercostal nerve block treatments, which temporarily numb the pain by blocking nerve signals, cryoablation targets the problem at the cellular level, potentially offering longer-lasting relief. Researchers are excited about this approach because it could provide a novel, minimally invasive way to reduce pain without the need for ongoing medication.

What evidence suggests that cryoablation is effective for postoperative pain?

This trial will compare cryoablation with intercostal nerve block for managing postoperative pain. Studies have shown that cryoablation effectively reduces pain by using extreme cold to target and freeze tissue. One study found cryoablation to be over 90% effective in preventing the need for additional surgeries, suggesting it can be a reliable option for pain management. Furthermore, researchers have found cryoablation to safely and effectively reduce pain in patients with bone-related conditions. Overall, these findings show promise for cryoablation as a treatment for post-surgical pain. ^{1 5 6 7 8}

Who Is on the Research Team?

Rishindra Reddy, MD, MBA

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for opioid-naïve patients undergoing elective open thoracic surgery or minimally invasive procedures at Michigan Medicine. It's not suitable for those with prior thoracic surgery, psychological disorders, redo ipsilateral thoracic surgery, pregnancy, fibromyalgia, cognitive impairment, or bilateral thoracotomy.

Inclusion Criteria

Patient is opioid naïve

I am eligible for a special freezing treatment for my condition at Michigan Medicine.

Exclusion Criteria

I have had surgery in my chest area before.

Patients with psychological disorders

Patients who are pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cryoablation or intercostal nerve block for post-surgical pain control

Approximately 3 days

In-hospital stay

Follow-up

Participants are monitored for safety, effectiveness, and chronic pain up to 180 days post-surgery

180 days

Multiple visits including 2-weeks, 30-, 90-, and 180-days post-op

What Are the Treatments Tested in This Trial?

Interventions

• Cryoablation

Trial Overview

The study compares traditional post-surgical pain control methods like epidural or intercostal nerve block against cryoablation using Atricure's crysoSPHERE probe to see if it offers better pain management after chest surgeries.

How Is the Trial Designed?

Group I: Cryoablation Experimental Treatment 1 Intervention

Cryoablation is a procedure that is used to freeze and burn away tissue cells via a device called a cryosphere which emits a freezing gas.

Group II: Intercostal nerve block Active Control 1 Intervention

Standard of care

Cryoablation is already approved in United States, European Union for the following indications:

Approved in United States as Cryoablation for:

• Liver cancer
• Kidney cancer
• Bone cancer
• Pain management

Approved in European Union as Cryoablation for:

• Liver cancer
• Kidney cancer
• Bone cancer
• Pain management

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

AtriCure, Inc.

Industry Sponsor

Trials

43

Recruited

22,800+

Published Research Related to This Trial

In a study of 14 patients with painful metastatic bone lesions, percutaneous cryoablation significantly reduced pain levels from an average of 6.7 to 3.8 out of 10 four weeks post-treatment, indicating its effectiveness in pain management.

All patients who were using narcotics before the procedure reported a decrease in their medication use after cryoablation, and no serious complications were observed, highlighting the safety of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Painful metastases involving bone: percutaneous image-guided cryoablation--prospective trial interim analysis. Callstrom, MR., Atwell, TD., Charboneau, JW., et al.[2022]

In a study involving 14 patients with vertebral metastases, percutaneous imaging-guided spine cryoablation significantly reduced pain and analgesic use at 1 week, 1 month, and 3 months post-procedure, demonstrating its effectiveness for pain management.

The procedure achieved local tumor control in 96.7% of treated tumors, indicating its efficacy in managing vertebral metastases, with only minor complications reported, such as transient radiculopathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spine Cryoablation: Pain Palliation and Local Tumor Control for Vertebral Metastases. Tomasian, A., Wallace, A., Northrup, B., et al.[2021]

Cryoanalgesia, or cryoneurolysis, is a safe and effective method for relieving pain by applying extreme cold to peripheral nerves, interrupting pain signals without causing permanent nerve damage.

This technique, guided by imaging methods like ultrasound or CT, offers a minimally invasive alternative to traditional pain management approaches, especially important in the context of the opioid crisis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous cryoanalgesia for pain palliation: Current status and future trends. Filippiadis, D., Efthymiou, E., Tsochatzis, A., et al.[2021]

Cryoanalgesia combined with opioids was found to be more effective than opioids alone for managing both acute and persistent postoperative pain in patients undergoing thoracotomy, based on a meta-analysis of 24 randomized controlled trials.

Additionally, patients receiving cryoanalgesia experienced significantly less postoperative nausea compared to those treated with opioids alone, suggesting a potential safety advantage in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryoanalgesia for postsurgical pain relief in adults: A systematic review and meta-analysis. Park, R., Coomber, M., Gilron, I., et al.[2022]

In a study of 42 patients with cirrhosis undergoing treatment for hepatocellular carcinoma, both image-guided percutaneous cryoablation and radiofrequency ablation showed similar overall complication rates, with 39.4% for cryoablation and 26.7% for radiofrequency ablation, indicating comparable safety profiles.

Severe complications were also similar between the two methods, with no significant differences in rates of severe or fatal complications, suggesting that both techniques are viable options for treating liver cancer in patients with cirrhosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous treatment of hepatocellular carcinoma in patients with cirrhosis: a comparison of the safety of cryoablation and radiofrequency ablation. Dunne, RM., Shyn, PB., Sung, JC., et al.[2022]

In a study of 61 patients undergoing CT-guided cryoablation for painful metastatic bone disease, significant reductions in pain scores and narcotic usage were observed both 24 hours and 3 months after the procedure, indicating its efficacy.

The procedure was found to be safe, with only 11% of patients experiencing complications, suggesting that cryoablation is a reliable option for managing pain in patients with musculoskeletal metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image-guided cryoablation for the treatment of painful musculoskeletal metastatic disease: a single-center experience. Prologo, JD., Passalacqua, M., Patel, I., et al.[2021]

In a study of 102 patients undergoing total knee arthroplasty, computer-assisted cryotherapy significantly reduced postoperative pain and opioid consumption during the first week compared to a control group.

While cryotherapy improved pain management, there were no significant differences in knee function or swelling between the two groups, indicating that while it helps with pain, it may not impact overall recovery metrics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of computer-assisted cryotherapy in the postoperative treatment after total knee arthroplasty: positive effects on pain and opioid consumption. Brouwers, HFG., de Vries, AJ., van Zuilen, M., et al.[2022]

Percutaneous cryoablation for renal tumors, performed under local anesthesia, demonstrated a high local recurrence-free survival rate of 91% at three and five years, particularly for tumors smaller than 3 cm, which had a 100% LRFS.

The procedure was generally safe, with a low rate of major complications (4.6%) and manageable hemorrhage being the most common issue, indicating that it can be effectively used in patients with significant comorbidities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Computed Tomography-guided Percutaneous Renal Cryoablation Under Local Anesthesia: A Single Center Experience in Taiwan. Lin, YT., Hung, SW., Liu, MC., et al.[2023]

This study aims to evaluate the safety of cryoablation in 10 patients with painful bone and soft tissue tumors, focusing on the prevalence of severe adverse events within 4 weeks post-treatment.

The effectiveness of cryoablation will also be assessed 4 weeks after the procedure, providing insights into its potential as a pain management option for patients who have not responded to other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Percutaneous Cryoablation in Patients with Painful Bone and Soft Tissue Tumors: A Single Center Prospective Study (SCIRO-1502). Iguchi, T., Sakurai, J., Hiraki, T., et al.[2017]

Cryoablation is a safe and effective minimally invasive procedure that significantly reduces pain in cancer patients with bone metastases, with the highest pain reduction observed 4 weeks post-treatment.

The procedure not only alleviates pain but also improves the quality of life for patients and decreases their reliance on analgesics, with a complication rate of 12.74% across 15 studies involving 376 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryoablation for the Palliation of Painful Bone Metastasis: A Systematic Review. Khanmohammadi, S., Noroozi, A., Yekaninejad, MS., et al.[2023]

Percutaneous cryoablation is an emerging image-guided technique that shows promise for effectively managing pain in patients with musculoskeletal metastases, offering a new option when conventional therapies are inadequate.

The technique has several advantages, including its minimally invasive nature and the potential for targeted pain relief, making it a valuable addition to current treatment options for metastatic lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryoablation in the musculoskeletal system. Ullrick, SR., Hebert, JJ., Davis, KW.[2007]

Recent advancements in cryoablation technology have made it suitable for percutaneous use by radiologists, allowing for targeted treatment of various tumors with image guidance.

Cryoablation offers distinct advantages over heat-based ablation techniques, including the use of local anesthesia, minimal pain, real-time monitoring, and the ability to treat larger or irregularly shaped tumors effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of cryoablation beyond the prostate. Yılmaz, S., Özdoğan, M., Cevener, M., et al.[2020]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10625427/

Pain-Free Survival After Percutaneous Image-Guided ...

Efficacy rate of cryoablation to avoid secondary surgery was 92.8% (39/42) per patient and 93.6% (44/47) per nodule treated. Four patients (9.5%, 4/42) had ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1051044323002592

Resolution of Pain after Percutaneous Image-Guided ...

The efficacy rate of cryoablation to avoid secondary surgery was 92.8% (39/42) per patient and 93.6% (44/47) per nodule treated. Four patients (9.5%, 4/42) ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5757505/

PERCUTANEOUS IMAGE - GUIDED CRYOABLATION OF ...

CONCLUSION. Percutaneous cryoablation is a safe, effective and durable method for palliation of pain due to metastatic disease involving bone. Keywords: ...

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insightsimaging.springeropen.com

insightsimaging.springeropen.com/articles/10.1186/s13244-024-01822-5

Percutaneous cryoablation in soft tissue tumor management

Finally, assessing 103 PCA sessions that targeted AWE, Bodard et al [2] observed a decrease in pain levels of 82 ± 13% (62–100% and a reduction ...

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0022346822001269

Short and long term outcomes of using cryoablation for ...

On follow-up, 55% of patients reported tolerable residual pain at two weeks and 41% at three months, with 25% requiring intermittent pain medication at three ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10898328/

Impact of cryoablation on operative outcomes in ...

Current evidence suggests cryoablation may decrease postoperative analgesia utilization, but could increase operative times.

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S000992602500011X

Safety of CT-guided percutaneous cryoablation in patients ...

This multicenter cohort study found a relatively high rate of postoperative complications in patients having a ureteral stent before PCA.

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ajronline.org

ajronline.org/doi/10.2214/ajr.24.31490

Safety and Efficacy of Percutaneous Cryoablation for ...

Percutaneous cryoablation has a favorable safety and efficacy profile in patients with recurrent or metastatic STS after earlier treatments.