Cryotherapy for Postoperative Pain

Overseen By Benny Weksler, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Must not be taking: Chronic narcotics

Disqualifiers: Low ejection fraction, High creatinine, Cirrhosis, Fibromyalgia, others

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

Compensation: Varies

Number of Visits: 2

Duration: Up to 14 days

110 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a research study designed to test whether a treatment called Intercostal Nerve Cryotherapy is an effective way to help control post-surgical pain for patients undergoing minimally invasive pulmonary resection. There are two treatment groups in this study, a cryotherapy group and control group. Cryotherapy is a method of controlling pain by freezing nerves between the ribs that would transmit pain impulses to the brain.

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, if you are on chronic narcotics for other reasons, you would not be eligible to participate.

Is cryotherapy for postoperative pain generally safe for humans?

Cryotherapy for postoperative pain, specifically intercostal nerve cryotherapy, is generally considered safe. Some patients may experience numbness in the skin near the treatment area, but serious side effects are rare. There have been no reports of nerve inflammation or abnormal tissue growth, and only a few cases of minor lung issues. ^{1 2 3 4 5}

How does cryotherapy differ from other treatments for postoperative pain?

Cryotherapy is unique because it involves freezing techniques to temporarily interrupt nerve function, providing pain relief without the use of drugs. It has been shown to reduce postoperative pain more effectively than local anesthetics and can decrease the need for opioids, ventilation days, and intensive care days in patients with rib fractures. ^{1 3 6 7 8}

What data supports the effectiveness of the treatment Intercostal Nerve Cryotherapy for postoperative pain?

Research shows that intercostal nerve cryotherapy can significantly reduce postoperative pain, as seen in patients undergoing thoracotomy (chest surgery) and aortic aneurysm repairs. Patients treated with this method experienced less pain and required fewer pain medications compared to those who received other treatments or no nerve block. ^{1 6 7 9 10}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are having minimally invasive lung surgery (like VATS or robotic) and can communicate in English. They should be relatively active (performance status of 1 or 2), not have had previous chest surgery on the same side, no severe heart issues (ejection fraction above 40%), normal kidney function, not have advanced liver disease, not be on long-term narcotics, and able to consent.

Inclusion Criteria

I am scheduled for a minor lung surgery using VATS or robotic methods.

I can do light work but not heavy physical activities.

Exclusion Criteria

I have been diagnosed with fibromyalgia.

You are regularly taking strong pain medications for other health reasons.

Your creatinine level is higher than 1.5.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo minimally invasive pulmonary resection with either cryoanalgesia and standard pain control or standard pain control alone

Up to 14 days

In-hospital stay

Follow-up

Participants are monitored for safety and effectiveness, including pain control and pulmonary complications

1 year

Multiple visits at 2 weeks, 3 months, 6 months, and 1 year post-operatively

What Are the Treatments Tested in This Trial?

Interventions

• Intercostal Nerve Cryotherapy

Trial Overview The study is testing Intercostal Nerve Cryotherapy—a pain control method that freezes nerves—to see if it's better than standard pain treatments after minimally invasive lung surgeries. Participants will either receive cryotherapy or the usual pain management as a control group.

How Is the Trial Designed?

Group I: Cryoanalgesia with standard of care pain control Experimental Treatment 2 Interventions

subjects will receive standard of care pain control + cryoanalgesia in the intercostal spaces during routine surgery

Group II: Standard of care pain control Active Control 1 Intervention

subjects will receive standard of care pain control only

Who Is Running the Clinical Trial?

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Lead Sponsor

Trials

52

Recruited

13,000+

AtriCure, Inc.

Industry Sponsor

Trials

43

Recruited

22,800+

Published Research Related to This Trial

In a study of 24 patients, those who received intercostal block using cryotherapy experienced significantly less postoperative pain compared to those who received local anesthetics or no blockade.

The nerve function interruption caused by cryotherapy was temporary, lasting no more than 30 days, and there were no adverse side effects reported, indicating a safe and effective pain management option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryoanalgesia for post-thoracotomy pain. Katz, J., Nelson, W., Forest, R., et al.[2019]

Ultrasound-guided percutaneous cryoneurolysis of the intercostal nerves was successfully used to treat a 40-year-old male with severe post-thoracotomy pain syndrome (PTPS) that had persisted for two years.

The treatment resulted in a 75% reduction in pain immediately after the procedure, with sustained 50% pain relief for eight weeks, suggesting that this method is a safe and effective option for managing chronic PTPS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-Guided Percutaneous Cryoneurolysis for Post-Thoracotomy Pain Syndrome: A Case Report. Perese, J., Oswald, J., Gabriel, RA.[2023]

In a study of 144 patients undergoing thoracotomy, those who received cryoanalgesia for pain relief required significantly less narcotics and experienced lower pain scores compared to those who received traditional bupivacaine-adrenaline blockade.

Cryoanalgesia was found to be safe, with no late nerve complications reported, suggesting it could be recommended for routine use in thoracotomy procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of post-thoracotomy pain by cryotherapy of intercostal nerves. Roberts, D., Pizzarelli, G., Lepore, V., et al.[2019]

In a study of 241 patients undergoing surgical stabilization of rib fractures, those who received intercostal nerve cryoablation used significantly fewer opioids post-operatively and had shorter stays in the intensive care unit compared to those who did not receive cryoablation.

Cryoablation did not increase the time spent in surgery or the risk of pulmonary complications, making it a safe adjunctive treatment that enhances pain management without additional risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intercostal nerve cryoablation during surgical stabilization of rib fractures decreases post-operative opioid use, ventilation days, and intensive care days. Marturano, MN., Thakkar, V., Wang, H., et al.[2023]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

Intraoperative Intercostal Nerve Cryoanalgesia Improves Pain Control After Descending and Thoracoabdominal Aortic Aneurysm Repairs. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Cryoanalgesia for post-thoracotomy pain. [2019]

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

Ultrasound-Guided Percutaneous Cryoneurolysis for Post-Thoracotomy Pain Syndrome: A Case Report. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Intercostal block with cryotherapy. [2020]

5. Sweden pubmed.ncbi.nlm.nih.gov

Reduction of post-thoracotomy pain by cryotherapy of intercostal nerves. [2019]

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

The role of cryoanalgesia for chronic thoracic pain: results of a long-term follow up. [2022]

7. Finland pubmed.ncbi.nlm.nih.gov

Neurological sequelae after cryoanalgesia for thoracotomy pain relief. [2004]

8. China pubmed.ncbi.nlm.nih.gov

[Analgesic effect and safety of intercostal nerve cryoanalgesia after the video-assisted thoracoscopic surgery]. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Role of cryoanalgesia in the control of pain after thoracotomy. [2019]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Intercostal nerve cryoablation during surgical stabilization of rib fractures decreases post-operative opioid use, ventilation days, and intensive care days. [2023]