Feasibility Study for Intrathoracic Nerve Stimulation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Investigational Device Exemption for Intrathoracic Nerve Stimulation

Conditions
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Postoperative Pain

Intervention / Treatment
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* Device: Peripheral Nerve Stimulation


Participation Criteria
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Eligibility Criteria
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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 who are on anticoagulation therapy that would preclude their ability to undergo the implant procedure, Subjects less than 22 years of age, Subjects at elevated risk of infection or bleeding, 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.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>Intrathoracic placement of neurostimulation device | Device: Peripheral Nerve Stimulation<br>* Medtronic Intellis Spinal Cord Stimulation Device to be implanted in thoracic cavity to treat postoperative acute pain.<br>* Other names: Off-label use of Medtronic Intellis Spinal Cord Stimulation Device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain as measured by the visual-analog scale | Pain level expressed by the study subject in the scale of 0 (no pain) to 10 (unbearable pain). Lower scores represent the better outcome. | Baseline to 3 months | 
| Freedom from device related adverse events | Freedom from device related adverse events (i.e., bleeding, infection, pneumothorax or arrhythmias) | up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine equivalents taken | Morphine equivalents taken during the inpatient period | up to 7 days | 
| Number of narcotics taken | Number of narcotics taken post discharge | 7 days to 3 months | 
| Pain control as measured by the McGill pain questionnaire | Pain characteristics expressed by the study subject for the following criteria: Throbbing, Shooting, Stabbing, Sharp, Cramping, Gnawing, Hot/Burning, Aching, Heavy, Tender, Splitting, Tiring/Exhausting, Sickening, Fearful, Punishing/Cruel, with the following scales: 0=None, 1=Mild, 2=Moderate, and 3=Severe. Lower scores represent the better outcome. | Screening, 7 days, 1 month and 3 month |