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

Trial Summary

What is the purpose of this trial?

The researchers will compare the common methods of post-surgical pain control, such as epidural or intercostal nerve block with a newer method called cryoablation. The research team is conducting this study to determine if cryoablation provides more effective pain control when compared to an epidural or intercostal nerve block.

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 data supports the effectiveness of the treatment Cryoablation for reducing postoperative pain?

Research shows that cryoablation, a treatment using extreme cold to target nerves, is effective in reducing pain for patients with bone metastases and can improve daily activities and reduce the need for pain medications. Additionally, cryotherapy has been found to reduce pain and the use of painkillers after knee surgery, suggesting its potential benefits for managing postoperative pain. ^{1 2 3 4 5}

Is cryoablation generally safe for humans?

Cryoablation has been studied for safety in various conditions, including painful bone and soft tissue tumors, renal tumors, and hepatocellular carcinoma. These studies generally suggest that cryoablation is safe, with a focus on monitoring severe adverse events shortly after the procedure. ^{3 6 7 8 9}

How is cryoablation treatment different for managing postoperative pain?

Cryoablation is unique because it is a minimally invasive treatment that uses extreme cold to numb nerves and reduce pain, unlike traditional methods that might rely on medications or heat-based techniques. It offers advantages such as local anesthesia, minimal pain during and after the procedure, and real-time monitoring, making it a promising option for pain management. ^{1 2 10 11 12}

Research Team

Rishindra Reddy, MD, MBA

Principal Investigator

University of Michigan

Eligibility Criteria

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

I have had chest surgery on the same side before.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Image-guided cryoablation for the treatment of painful musculoskeletal metastatic disease: a single-center experience. [2021]

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

Spine Cryoablation: Pain Palliation and Local Tumor Control for Vertebral Metastases. [2021]

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

Painful metastases involving bone: percutaneous image-guided cryoablation--prospective trial interim analysis. [2022]

4. France pubmed.ncbi.nlm.nih.gov

Percutaneous cryoanalgesia for pain palliation: Current status and future trends. [2021]

5. Germany 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. [2022]

6. Greece pubmed.ncbi.nlm.nih.gov

Feasibility of Computed Tomography-guided Percutaneous Renal Cryoablation Under Local Anesthesia: A Single Center Experience in Taiwan. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Cryoanalgesia for postsurgical pain relief in adults: A systematic review and meta-analysis. [2022]

8. Japan 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). [2017]

9. Ireland pubmed.ncbi.nlm.nih.gov

Percutaneous treatment of hepatocellular carcinoma in patients with cirrhosis: a comparison of the safety of cryoablation and radiofrequency ablation. [2022]

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

Cryoablation for the Palliation of Painful Bone Metastasis: A Systematic Review. [2023]

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

Cryoablation in the musculoskeletal system. [2007]

12. Germany pubmed.ncbi.nlm.nih.gov

Use of cryoablation beyond the prostate. [2020]