Feasibility Study for Intrathoracic Nerve Stimulation
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|ClinicalTrials.gov Identifier: NCT04066374|
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : September 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain||Device: Peripheral Nerve Stimulation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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)
- Morphine equivalents taken [ Time Frame: up to 7 days ]Morphine equivalents taken during the inpatient period
- Number of narcotics taken [ Time Frame: 7 days to 3 months ]Number of narcotics taken post discharge
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04066374
|Contact: Usman Ahmad, M. D.||firstname.lastname@example.org|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Contact: Usman Ahmad, M. D. 216-444-1921 email@example.com|
|Sub-Investigator: Sean Nagel, M. D.|
|Sub-Investigator: Sudish Murthy, M. D.|
|Principal Investigator:||Usman Ahmad, M. D.||The Cleveland Clinic|