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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the time of chest tube removal to 24 hours after chest tube removal
Awards & highlights
Study Summary
This trial is testing whether freezing nerves around the lungs can reduce post-operative pain enough to reduce the need for opioids in opioid-tolerant patients.
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.Check my eligibility
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.See study design
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 belowSelect...
I have been using opioids daily for at least a month in the past year or am currently using them.
Select...
I need surgery for my condition using a robot-assisted method.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Opioid Use Within 24 Hours After Chest Tube Removal
Secondary outcome measures
Length of Hospital Stay
Mean Cost of Hospital Care
Neuroma Formation
+6 moreTrial 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
Find a Location
Who is running the clinical trial?
The Methodist Hospital Research InstituteLead Sponsor
271 Previous Clinical Trials
80,300 Total Patients Enrolled
Min Kim, MDPrincipal InvestigatorThe Methodist Hospital Research Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had major chest surgery before.You are allergic to plastic materials.I have been using opioids daily for at least a month in the past year or am currently using them.You are allergic to aluminum.I have a condition that damages the protective covering of my nerves.I need surgery for my condition using a robot-assisted method.I have shingles.You are allergic to bupivacaine.I am between 18 and 90 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Historical Controls
- Group 2: Nerve Block Using Liposomal Bupivacaine and cryoSPHERE Ablation
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this study accept participants who are 65 years or older?
"The age requirements for this trial stipulate that all participants need to be between 18 and 90 years old. Additionally, 138 trials are available specifically tailored to minors while 610 focus on those above the pensionable age range."
Answered by AI
Is it feasible to join this experiment?
"To be eligible for this medical trial, applicants must have experienced postoperative pain and fit within the accepted age range (18-90). The number of participants is limited to 150."
Answered by AI
Are there any vacant slots available for participation in this experiment?
"Unfortunately, the clinical trial is no longer recruiting. It first appeared on March 15th 2022 and was recently updated on March 2nd 2022. Therefore, this particular study cannot accept any more applicants; however, there are 818 other studies that remain open for enrollment."
Answered by AI
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