Feasibility Study for Intrathoracic Nerve Stimulation

Investigational Device Exemption for Intrathoracic Nerve Stimulation

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Device: Peripheral Nerve Stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Off-label use of Medtronic Intellis Spinal Cord Stimulation Device

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Sudish Murthy, MD PhD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2019
• Primary Completion (Actual): January 9, 2024
• Study Completion (Actual): June 11, 2024

Study Registration Dates

• First Submitted: August 20, 2019
• First Submitted That Met QC Criteria: August 22, 2019
• First Posted (Actual): August 26, 2019

Study Record Updates

• Last Update Posted (Actual): July 9, 2024
• Last Update Submitted That Met QC Criteria: June 14, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: G190122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes