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Peripheral Nerve Stimulation
Intrathoracic Nerve Stimulation for Postoperative Pain
N/A
Waitlist Available
Led By Usman Ahmad, M. D.
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients undergoing pulmonary surgery by open thoracotomy or thoracoscopy with or without robotic assistance.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 3 months
Awards & highlights
Study Summary
This trial is testing whether a new pain control method using electrical stimulation of the nerves in the chest is safe and effective.
Who is the study for?
This trial is for patients having lung surgery via open or minimally invasive methods, who can consent to participate. It's not for those under 22, pregnant women, people with infections, immune issues, preoperative chest pain, severe allergies to neurostimulator materials, risk of bleeding/infection or those needing MRI/diathermy.Check my eligibility
What is being tested?
The study tests the safety and feasibility of using Peripheral Nerve Stimulation (PNS) on intercostal nerves inside the thoracic cavity as a method to control pain after surgeries involving the chest area like lung surgery.See study design
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site, infection risks due to implantation procedure and possible allergic reactions if sensitive to device materials.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am having lung surgery, which may include robotic help.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Freedom from device related adverse events
Pain as measured by the visual-analog scale
Secondary outcome measures
Morphine equivalents taken
Number of narcotics taken
Pain
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment1 Intervention
Intrathoracic placement of neurostimulation device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Peripheral Nerve Stimulation
2016
Completed Phase 1
~1380
Find a Location
Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
1,030 Previous Clinical Trials
1,364,008 Total Patients Enrolled
9 Trials studying Postoperative Pain
3,065 Patients Enrolled for Postoperative Pain
Usman Ahmad, M. D.Principal InvestigatorThe Cleveland Clinic
Sudish Murthy, MD PhDPrincipal InvestigatorThe Cleveland Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a blood clotting disorder that cannot be corrected.I am under 22 years old.I experience chest pain before surgery.I have an ongoing infection or a weakened immune system.I am scheduled for or have had a pneumonectomy.You have a device inside your body that runs on electricity, like a pacemaker or a neurostimulator.I am at a high risk of getting infections or bleeding.My immune system is weaker than normal.I am on blood thinners that prevent me from having surgery.I currently have an active infection.I am having lung surgery, which may include robotic help.I am having surgery on my esophagus, trachea, or stomach.I have an infection or inflammation in the space around my lungs.I am unable to give my consent by myself.I am currently pregnant.You cannot have diathermy or MRI procedures during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm
Awards:
This trial has 1 awards, including:- 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.
How many participants has the trial recruited thus far?
"Affirmative, according to clinicaltrials.gov this study is presently enrolling participants and was initially published on August 13th 2019. The last update came on May 19th 2022 and the trial has a capacity of 10 patients at 1 centre."
Answered by AI
Are there still openings available in this experiment for participants?
"Based on the information available at clinicaltrials.gov, this research project is recruiting participants and was initially posted in August 2019 with recent updates as late as May 2022."
Answered by AI
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