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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 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

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.

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteLead Sponsor
282 Previous Clinical Trials
81,473 Total Patients Enrolled
Min Kim, MDPrincipal InvestigatorThe Methodist Hospital Research Institute

Media Library

cryoSPHERE Ablation (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05276258 — N/A
Pain Research Study Groups: Historical Controls, Nerve Block Using Liposomal Bupivacaine and cryoSPHERE Ablation
Pain Clinical Trial 2023: cryoSPHERE Ablation Highlights & Side Effects. Trial Name: NCT05276258 — N/A
cryoSPHERE Ablation (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05276258 — N/A
~15 spots leftby Mar 2025