What side effects are associated with this type of intervention?

Common treatments for pain management similar to cryoablation include cryotherapy and scalp hypothermia. The known side effects of these treatments are generally mild and include headache, feeling cold, nausea, dry skin, and discomfort from the cold. In some cases, patients may experience scalp pain, neck pain, and a sensation of heaviness in the head. These side effects are typically minimal to modest in severity.

What prior FDA approvals exist?

The FDA has approved various treatments for pain management, including non-invasive techniques like transcranial magnetic stimulation (TMS) and remote electrical neuromodulation devices. These treatments have shown efficacy in clinical trials for conditions such as migraine. For instance, TMS has been approved for use in the United States and has demonstrated significant pain relief in patients with episodic migraine with aura. Similarly, remote electrical neuromodulation devices have been approved and shown to provide pain relief with minimal adverse events. While specific FDA approvals for cryoablation techniques like the cryoSPHERE probe are not detailed, these non-invasive neuromodulation methods represent a similar approach to managing pain through advanced technological interventions.

What other types of research exist?

Promising alternatives to the cryoSPHERE probe for pain management in 2024 include spinal cord stimulation (SCS), high-frequency (10-kHz) spinal cord stimulation, and transcutaneous electrical nerve stimulation (TENS). These methods have shown efficacy in managing different types of pain, including diabetic neuropathy and chemotherapy-induced peripheral neuropathy.

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Other

Nerve Freezing for Postoperative Pain

N/A

Waitlist Available

Led By Min Kim, MD

Research Sponsored by The Methodist Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Daily opioid use for at least 30 days consecutively at any point during the last 12 months prior to surgery or using opioids at the time of study enrollment

Diagnosis requiring robotic-assisted thoracoscopic surgery

Must not have

Previous major surgery at the operative site (thoracotomy)

Demyelinating illnesses

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the time of chest tube removal to 24 hours after chest tube removal

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include typical reactions to cold therapy like numbness or skin irritation around the treatment area. Bupivacaine can cause nerve damage symptoms such as tingling or weakness but is generally considered safe.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had major chest surgery before.

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I have a condition that damages the protective covering of my nerves.

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I have shingles.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the time of chest tube removal to 24 hours after chest tube removal

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the time of chest tube removal to 24 hours after chest tube removal

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time of chest tube removal to 24 hours after chest tube removal for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Opioid Use Within 24 Hours After Chest Tube Removal

Secondary study objectives

Length of Hospital Stay

Mean Cost of Hospital Care

Neuroma Formation

+6 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Nerve Block Using Liposomal Bupivacaine and cryoSPHERE AblationExperimental Treatment2 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 ControlsExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bupivacaine

FDA approved

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cryoablation, such as the cryoSPHERE probe, works by applying extreme cold to nerve tissues, leading to a temporary interruption in nerve signaling and thus reducing pain. This method is particularly useful for patients who are opioid-tolerant or seeking alternatives to opioid medications. Other common pain treatments include opioids, which bind to specific receptors in the brain and spinal cord to block pain signals, and nonsteroidal anti-inflammatory drugs (NSAIDs), which reduce inflammation and pain by inhibiting enzymes involved in the inflammatory process. Understanding these mechanisms is crucial for pain patients as it allows for tailored treatment plans that can effectively manage pain while minimizing side effects and addressing individual patient needs.