Nerve Freezing for Postoperative Pain

Overseen By Darrel Cleere, BSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Methodist Hospital Research Institute

Must be taking: Opioids

Disqualifiers: Previous thoracotomy, Shingles, others

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

Compensation: Varies

Number of Visits: 6

Duration: Immediate post-operative period

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new tool called the cryoSPHERE probe that freezes nerves to reduce pain after chest surgery. It aims to help patients who usually need a lot of opioids for pain relief. By freezing the nerves, it blocks pain signals and reduces the need for opioid medications. This technique has been used in various forms for pain management, including post-surgery pain and chronic pain conditions.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, since the study involves pain management, you might need to discuss your current medications with the study team.

Is nerve freezing generally safe for humans?

Nerve freezing, also known as cryoanalgesia or cryoneurolysis, has been used for various types of pain management and is generally considered safe, but it can cause temporary changes in nerve function. Some studies suggest that if the nerve is not adequately frozen, it might lead to temporary pain, and there is ongoing research to ensure it does not cause lasting motor function issues. ^{1 2 3 4 5}

How is the cryoSPHERE Ablation treatment different from other treatments for postoperative pain?

CryoSPHERE Ablation, a form of cryoanalgesia, is unique because it uses extreme cold to freeze nerves, providing long-term pain relief by disrupting nerve function without permanently damaging the nerve structure. This method is different from other treatments like alcohol or phenol neurolysis, as it preserves the nerve's protective layers, allowing for potential nerve recovery. ^{1 4 5 6 7}

What data supports the effectiveness of the treatment cryoSPHERE Ablation for postoperative pain?

Cryoanalgesia, a technique similar to cryoSPHERE Ablation, has been shown to provide long-term pain relief by freezing nerves, which can help manage various types of pain, including postoperative pain. Studies have demonstrated that cryoanalgesia can relieve pain for several months, allowing patients to resume normal activities during this period. ^{1 2 4 5 7}

Who Is on the Research Team?

Min Kim, MD

Principal Investigator

The Methodist Hospital Research Institute

Are You a Good Fit for This Trial?

This trial is for adults aged 18-90 who are opioid-tolerant due to daily use at some point in the past year or current use, and require robotic-assisted thoracoscopic surgery. Participants must not be involved in other studies, have allergies to aluminum, plastics, bupivacaine, or have shingles or demyelinating diseases.

Inclusion Criteria

I have been using opioids daily for at least a month in the past year or am currently using them.

Experimental group only: agreement and consent to comply with all aspects of the study protocol and data collection, including follow-up contact.

I need surgery for my condition using a robot-assisted method.

Exclusion Criteria

I have had major chest surgery before.

You are allergic to plastic materials.

You are allergic to aluminum.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cryoSPHERE ablation of intercostal nerves and liposomal bupivacaine during robotic-assisted thoracoscopic surgery

Immediate post-operative period

1 visit (in-person)

Follow-up

Participants are monitored for opioid use, pain levels, and neuroma formation after surgery

6 months

Multiple visits (in-person and virtual) at 5 weeks, 3 months, and 6 months

Long-term Follow-up

Participants are monitored for long-term outcomes such as length of hospital stay, readmissions, and adverse effects

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• cryoSPHERE Ablation

Trial Overview The study compares cryoablation using the cryoSPHERE probe with standard pain management methods after robotic-assisted thoracoscopic surgery. It aims to see if this new method reduces the need for opioid painkillers and lowers post-surgery complications.

How Is the Trial Designed?

Group I: Nerve Block Using Liposomal Bupivacaine and cryoSPHERE Ablation Experimental Treatment 2 Interventions

The experimental group (75 participants) will undergo intercostal nerve block using liposomal bupivacaine and the cryoSPHERE ablation of intercostal nerves during robotic-assisted thoracoscopic operation at Houston Methodist Hospital.

Group II: Historical Controls Experimental Treatment 1 Intervention

A total of 75 propensity score-matched historical controls will be selected from the pool of patients who had standard intercostal nerve block using liposomal bupivacaine alone at Houston Methodist Hospital from January 1, 2017 through January 1, 2022, inclusively.

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials

299

Recruited

82,500+

Published Research Related to This Trial

Cryoneuroablation, or cryoanalgesia, is an effective long-term pain relief technique that works by freezing nerves to create a conduction block, similar to local anesthetics, and is used for various types of pain including craniofacial, abdominal, and lower back pain.

This method causes vascular damage and nerve disruption while preserving the myelin sheath, allowing for targeted pain management in conditions like trigeminal neuralgia and post-thoracotomy pain, making it a valuable option in interventional pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryoanalgesia in interventional pain management. Trescot, AM.[2022]

The size of the ice ball created during ultrasound-guided percutaneous cryoneurolysis is significantly influenced by the gauge of the cryoprobe used, with larger probes (14 gauge) producing ice balls that are up to 512% larger and achieving much lower temperatures compared to smaller probes (18 gauge).

Visualizing a nerve fully encompassed in an ice ball does not guarantee effective treatment, as temperatures within the ice ball may not reach the levels necessary to induce Wallerian degeneration, highlighting the need for further research to understand the implications for human tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relative Effects of Various Factors on Ice Ball Formation and Ablation Zone Size During Ultrasound-Guided Percutaneous Cryoneurolysis: A Laboratory Investigation to Inform Clinical Practice and Future Research. Said, ET., Marsh-Armstrong, BP., Fischer, SJ., et al.[2023]

Citations

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

Characterization of a neuropathic pain model: sciatic cryoneurolysis in the rat. [2021]

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

Cryoanalgesia in interventional pain management. [2022]

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

Cryoanalgesia for painful peripheral nerve lesions. [2021]

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

Does cryoneurolysis result in persistent motor deficits? A controlled study using a rat peroneal nerve injury model. [2021]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Relative Effects of Various Factors on Ice Ball Formation and Ablation Zone Size During Ultrasound-Guided Percutaneous Cryoneurolysis: A Laboratory Investigation to Inform Clinical Practice and Future Research. [2023]

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

Ultrasonographic guidance and characterization of cryoanalgesic lesions in treating a case of refractory sural neuroma. [2021]

7. Ireland pubmed.ncbi.nlm.nih.gov

Recovery of function after cryosurgical lesions of peripheral nerves in rats. [2019]