Feasibility Study for Intrathoracic Nerve Stimulation

NCT ID: NCT04066374

Last Updated: 2024-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-13
• Study Completion Date: 2024-06-11

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.

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm

Intrathoracic placement of neurostimulation device

Group Type: EXPERIMENTAL

Peripheral Nerve Stimulation

Intervention Type: DEVICE

Medtronic Intellis Spinal Cord Stimulation Device to be implanted in thoracic cavity to treat postoperative acute pain.

Interventions

Peripheral Nerve Stimulation

Medtronic Intellis Spinal Cord Stimulation Device to be implanted in thoracic cavity to treat postoperative acute pain.

Intervention Type: DEVICE

Other Intervention Names

Off-label use of Medtronic Intellis Spinal Cord Stimulation Device

Eligibility Criteria

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.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sudish Murthy, MD PhD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

G190122

Identifier Type: -

Identifier Source: org_study_id