Feasibility Study for Intrathoracic Nerve Stimulation

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


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.


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.

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


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
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