Feasibility Study for Intrathoracic Nerve Stimulation

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    10
  • sponsor
    The Cleveland Clinic
Updated on 8 June 2022
analgesia
spinal cord
thoracotomy
acute pain
pain relieving

Summary

The purpose of this study is to conduct an early clinical evaluation of safety and feasibility of peripheral nerve stimulation (PNS) of the intercostal nerves using an electrical lead placed in the thoracic cavity as a safe and effective method of pain control after cardiothoracic surgery.

Description

Despite minimally invasive techniques in thoracic surgery, postoperative pain can still be an issue for patients. Achieving adequate pain control not only affects a patient's short and long term quality of life but is also extremely important in preventing post-operative complications. Pain hinders with ambulating earlier and in performing pulmonary toilet hence increasing the risk of ensuing complications. While surgeons use multimodal approaches (e.g., epidural, regional anesthesia, NSAIDs, and opioids) to treat the postoperative pain, patients may not find relief in the acute period. Additionally, the use of opioids in the postoperative period can lead to chronic dependence and misuse. According to the Center for Disease Control, nearly 25% of patients chronically dependent on opioids started taking narcotics after they underwent a surgical procedure. Every day more than 115 people a day die from narcotics, and costing the United States $78.5 billion dollars a year. To prevent the need for opioids and their associated side effects, we look beyond medications for postoperative pain control.

The field of neuromodulation has been studying the effects of magnetic field and electrical current stimulation of different areas of the body to treat pain. While this has been shown to be effective for complex regional pain syndrome, low back pain, migraines and post herpetic neuralgia, there have not been studies applying the same concept to patients in the acute postoperative period. The goal is to apply the same concept of peripheral nerve stimulation to treat post thoracic surgery pain and decrease the need for opioids for pain relief.

The purpose of this investigational device exemption is to study the efficacy of peripheral nerve stimulation in treating post thoracic surgery pain and the safety of using these stimulation leads in the thoracic cavity.

Details
Condition Postoperative Pain
Treatment Peripheral Nerve Stimulation
Clinical Study IdentifierNCT04066374
SponsorThe Cleveland Clinic
Last Modified on8 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

• Patients undergoing pulmonary surgery by open thoracotomy or thoracoscopy with or without
robotic assistance

Exclusion Criteria

Woman who is pregnant
Subjects who have an active systemic infection or are immunocompromised
Subjects who will be exposed to diathermy or MRI
Subjects who have an electrically active implant, e.g., cardiac pacemaker
defibrillator, or neurostimulator
Subjects less than 22 years of age
Subjects who are on anticoagulation therapy that would preclude their ability to
Subjects at elevated risk of infection or bleeding
undergo the implant procedure
Subjects unable to consent on their own
Subjects with active infection
Subjects with immunocompromised state
Subjects with preoperative chest pain
Subjects with pleural space infection or inflammatory process
Subjects undergoing esophageal, tracheal, or gastric procedures
Subjects undergoing pneumonectomy
Subjects with an uncorrectable coagulopathy
Subjects who are allergic or have shown hypersensitivity to any materials of the
neurostimulation system which come in contact with the body
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note