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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether freezing nerves between the ribs, known as intercostal nerve cryotherapy, can help manage pain after lung surgery. Participants will receive either cryotherapy with standard pain control or just standard pain control to determine which is more effective. The trial targets individuals undergoing minimally invasive lung surgery for nodules, such as lung segment or lobe removal. Ideal candidates are those scheduled for this surgery who are not on long-term narcotics and do not have certain health conditions. The goal is to find a better way to control post-surgery pain. As an unphased trial, it offers participants the opportunity to contribute to innovative pain management solutions after lung surgery.

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.

What prior data suggests that Intercostal Nerve Cryotherapy is safe for controlling post-surgical pain?

Research has shown that Intercostal Nerve Cryotherapy is generally safe. Studies have found that patients who received this treatment experienced good pain relief after surgery, with less intense pain. One study discovered that combining cryotherapy with standard pain control methods reduced the need for opioid painkillers, which can cause side effects like nausea.

Other research supports that cryotherapy is well-tolerated, with no major complications reported. However, experts recommend more extensive studies to confirm these findings, especially for patients who have more difficulty managing pain. Overall, current evidence suggests that Intercostal Nerve Cryotherapy is a promising and safe option for controlling pain after surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about intercostal nerve cryotherapy for postoperative pain because it offers a unique approach by directly targeting nerves with cold therapy to numb them and reduce pain signals. Most current treatments for postoperative pain rely on medications like opioids or non-steroidal anti-inflammatory drugs (NSAIDs), which work systemically and can have various side effects. Cryotherapy, on the other hand, is localized, potentially reducing the need for systemic pain medications and their associated risks. This method could lead to better pain management with fewer side effects, making recovery more comfortable for patients.

What evidence suggests that this trial's treatments could be effective for controlling post-surgical pain?

Research has shown that freezing the nerves between the ribs, known as intercostal nerve cryotherapy, can help control pain after surgery. In this trial, participants in one arm will receive cryoanalgesia along with standard pain control. One study found that patients who received this treatment during lung surgery experienced less pain and needed fewer painkillers afterward. Another study found it significantly lowered pain levels, allowing patients to feel better and require less medication. This method has been used for many years and has shown promising results in reducing post-surgical pain. ^{1 2 3 6 7}

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9878586/

Intercostal nerve cryoanalgesia in the treatment of pain ... The aim of this study was to evaluate the effectiveness of intraoperative intercostal nerve cryolysis in terms of pain management in relation to the routinely ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0022522325004659

Intercostal cryoanalgesia for acute pain after video ... This study aimed to assess the analgesic benefit of intercostal cryoanalgesia in VATS lung cancer surgery. The primary outcome was thoracic pain ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05859061

Study Details | NCT05859061 | Cryoanalgesia Study Cryoanalgesia has been used for decades for pain control after thoracic surgery and has been associated with decreased opioid consumption, decreased pain scores ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11355873/

One- versus Two-Minute Intercostal Nerve Cryoanalgesia ... In our study, the occurrence of pain at rest was observed in one patient and on exertion in six patients (18%) 3 months after surgery. In our ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2950553425000760

Analgesic outcomes following ultrasound-guided ... Following cryoneurolysis, each patient reported significant pain relief, as was exhibited by a reduction in pain scores, as well as weaning from opioid ...

6. aats.org aats.org/resources/efficacy-of-intercostal-cryoan-7362

156. Efficacy of Intercostal Cryoanalgesia in Patients ... Cryoanalgesia appears effective and safe. Larger studies are necessary for validation, especially in patients where pain control is more problematic.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2049080121006397

Review Cryoanalgesia for postsurgical pain relief in adults Cryoanalgesia with opioids also resulted in less postoperative nausea compared to opioid analgesia alone (relative risk [RR] 0.23, 95 % CI 0.06 to 0.95), but ...