Nerve Freezing for Postoperative Pain

Recruiting in Palo Alto (17 mi)

Overseen byMin Kim, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: The Methodist Hospital Research Institute

No Placebo Group

Trial Summary

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.

Eligibility Criteria

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.

+1 more

Exclusion Criteria

I have had major chest surgery before.

You are allergic to plastic materials.

You are allergic to aluminum.

+4 more

Participant Groups

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.

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.