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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if cryoSPHERE ablation, a nerve-freezing technique, can manage pain after lung surgery more effectively than the usual treatment. The study will assess whether this method reduces the need for opioid painkillers and lowers post-surgery complications. Participants must have undergone robotic-assisted lung surgery and used opioids regularly in the past year. The trial compares the new method to past cases that used only standard pain treatment. As an unphased trial, it offers a unique opportunity to explore innovative pain management techniques after surgery.

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.

What prior data suggests that the cryoSPHERE probe is safe for postoperative pain management?

Research has shown that cryoSPHERE ablation, a method using cold to numb nerves, is safe and effective for managing pain. One study found that patients using a similar device reported low pain levels upon hospital discharge, with an average pain score of 1.5 out of 10. At follow-up, their pain score further decreased to 0.69 out of 10. Another study found that most patients regained feeling in the treated area within three months, with recovery rates ranging from 60% to 94.7%. These results suggest that cryoSPHERE ablation is generally well-tolerated with few serious side effects. However, individual experiences may vary with any treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about nerve freezing for postoperative pain because it offers a fresh approach to pain management. Unlike traditional treatments that rely solely on medications like liposomal bupivacaine, this method uses cryoSPHERE ablation to target intercostal nerves directly during surgery. This technique aims to provide longer-lasting pain relief by essentially "freezing" the nerves, which can potentially reduce the need for frequent medication doses. This innovative mechanism not only promises effective pain control but also offers the potential for quicker recovery times and fewer side effects.

What evidence suggests that cryoSPHERE ablation is effective for postoperative pain management?

Research has shown that cryoSPHERE ablation, which involves freezing nerves, can reduce post-surgical pain. In one study, patients using the cryoICE™ device reported low pain levels, averaging 1.5 out of 10 upon hospital discharge and 0.69 at a later check-up. Most patients regained sensation in the treated area within a year, with 98.3% fully recovering and only a few experiencing minor ongoing issues. However, another study found that this technique did not reduce pain or the need for painkillers after surgery and might even increase nerve pain. In this trial, participants will receive a nerve block using liposomal bupivacaine combined with cryoSPHERE ablation. Despite mixed results from previous research, this method shows potential, particularly for those seeking to manage post-surgical pain. ^{1 2 3 4 6}

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

You are allergic to plastic materials.

I have had major chest surgery before.

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

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05276258

Cryoablation of Intercostal Nerves for Post-Operative Pain ... The main objective study is to compare the use of the cryoSPHERE probe to the standard-of-care method for pain management of patients receiving ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11264104/

Clinical Outcomes of Cryo Nerve Ablation Technique for Pain ... The cryoICE™ device group had a mean value of incisional pain at hospital discharge was 1.5 (scale 0–10) while at follow-up was 0.69 (scale 0–10). Mean values ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0022346824008066

Sensory Recovery Following Intercostal Nerve ... This was achieved postoperatively by 14.9% at 3 months, 62.3% at 6 months, 85.1% at 9 months, and 98.3% at 12 months. 1.7% had a small area of persistent/ ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39522714/

A randomized study of cryoablation of intercostal nerves in ... Conclusions: In this randomized study, cryoanalgesia did not decrease postoperative pain or narcotic requirements. Cryoanalgesia increased neuropathic pain 2 ...

5. ccts.amegroups.org ccts.amegroups.org/article/view/104585/html

Role of intercostal nerve block and cryoneurolysis in the ... A large-scale study by Moore et al. [1962] involving 4,333 patients who underwent ICNB over a 12-year period confirmed its high efficacy for both thoracic and ...

6. withpower.com withpower.com/trial/phase-pain-2-2022-9b020

Nerve Freezing for Postoperative Pain · Info for Participants 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 ...