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Cryotherapy for Postoperative Pain

N/A
Recruiting
Research Sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Undergoing elective minimally invasive (VATS or robotic) lung resection for nodules (wedge resection, segmentectomy, lobectomy)
Performance status of 1 or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 1 year
Awards & highlights

Study Summary

This trial will help determine if cryotherapy is an effective way to control post-surgical pain for patients undergoing minimally invasive pulmonary resection.

Who is the study for?
This trial is for adults over 18 who are having minimally invasive lung surgery (like VATS or robotic) and can communicate in English. They should be relatively active (performance status of 1 or 2), not have had previous chest surgery on the same side, no severe heart issues (ejection fraction above 40%), normal kidney function, not have advanced liver disease, not be on long-term narcotics, and able to consent.Check my eligibility
What is being tested?
The study is testing Intercostal Nerve Cryotherapy—a pain control method that freezes nerves—to see if it's better than standard pain treatments after minimally invasive lung surgeries. Participants will either receive cryotherapy or the usual pain management as a control group.See study design
What are the potential side effects?
Cryotherapy may cause temporary numbness or tingling near the treated area due to nerve freezing. There might also be risks associated with cold treatment like skin damage but these are generally rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for a minor lung surgery using VATS or robotic methods.
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I can do light work but not heavy physical activities.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain control
Total morphine dose
Secondary outcome measures
Hospital length of stay
Incentive Spirometer Volume
Presence of neuropathy in the surgical site
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cryoanalgesia with standard of care pain controlExperimental Treatment2 Interventions
subjects will receive standard of care pain control + cryoanalgesia in the intercostal spaces during routine surgery
Group II: Standard of care pain controlActive Control1 Intervention
subjects will receive standard of care pain control only

Find a Location

Who is running the clinical trial?

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Lead Sponsor
47 Previous Clinical Trials
12,969 Total Patients Enrolled
AtriCure, Inc.Industry Sponsor
41 Previous Clinical Trials
17,361 Total Patients Enrolled

Media Library

cryoanalgesia Clinical Trial Eligibility Overview. Trial Name: NCT05348447 — N/A
Postoperative Pain Research Study Groups: Cryoanalgesia with standard of care pain control, Standard of care pain control
Postoperative Pain Clinical Trial 2023: cryoanalgesia Highlights & Side Effects. Trial Name: NCT05348447 — N/A
cryoanalgesia 2023 Treatment Timeline for Medical Study. Trial Name: NCT05348447 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What outcomes does this experiment seek to accomplish?

"According to AtriCure, Inc., the principal metric they intend to measure over a 14-day period is pain control. Secondary objectives include monitoring total morphine equivalent dose of narcotics and scoring patient's comfort via visual analog scale (0-10). Additionally, hospital length of stay will be tracked postoperatively."

Answered by AI

Are there currently any openings in this trial for those seeking treatment?

"According to the records available on clinicaltrials.gov, this medical study is actively seeking applicants as of April 21st 2022. The trial was initially uploaded on the same day and has not been changed since then."

Answered by AI

How many participants are being accepted into this research project?

"Affirmative, clinicaltrials.gov displays that this research is still recruiting volunteers. It was first made available on April 21st 2022 and recently updated the same day--the trial requires 100 participants from only one site."

Answered by AI
~28 spots leftby Dec 2024