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Feasibility Study for Intrathoracic Nerve Stimulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04066374
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : September 12, 2019
Information provided by (Responsible Party):
Usman Ahmad, MD, The Cleveland Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Device: Peripheral Nerve Stimulation Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigational Device Exemption for Intrathoracic Nerve Stimulation
Actual Study Start Date : August 13, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: Treatment Arm
Intrathoracic placement of neurostimulation device
Device: Peripheral Nerve Stimulation
Medtronic Intellis Spinal Cord Stimulation Device to be implanted in thoracic cavity to treat postoperative acute pain.
Other Name: Off-label use of Medtronic Intellis Spinal Cord Stimulation Device

Primary Outcome Measures :
  1. Pain as measured by the visual-analog scale [ Time Frame: Baseline to 3 months ]
    Pain level expressed by the study subject in the scale of 0 (no pain) to 10 (unbearable pain). Lower scores represent the better outcome.

  2. Freedom from device related adverse events [ Time Frame: up to 7 days ]
    Freedom from device related adverse events (i.e., bleeding, infection, pneumothorax or arrhythmias)

Secondary Outcome Measures :
  1. Morphine equivalents taken [ Time Frame: up to 7 days ]
    Morphine equivalents taken during the inpatient period

  2. Number of narcotics taken [ Time Frame: 7 days to 3 months ]
    Number of narcotics taken post discharge

  3. Pain control as measured by the McGill pain questionnaire [ Time Frame: Screening, 7 days, 1 month and 3 month ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04066374

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Contact: Usman Ahmad, M. D. 216-444-1921

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United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Usman Ahmad, M. D.    216-444-1921   
Sub-Investigator: Sean Nagel, M. D.         
Sub-Investigator: Sudish Murthy, M. D.         
Sponsors and Collaborators
The Cleveland Clinic
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Principal Investigator: Usman Ahmad, M. D. The Cleveland Clinic
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Responsible Party: Usman Ahmad, MD, Principal Investigator, The Cleveland Clinic Identifier: NCT04066374    
Other Study ID Numbers: G190122
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms