Feasibility Study for Intrathoracic Nerve Stimulation

Postoperative Pain Clinical Trial

Official title:

Investigational Device Exemption for Intrathoracic Nerve Stimulation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04066374
• Other study ID #: G190122
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 13, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Freedom from device related adverse events	Freedom from device related adverse events (i.e., bleeding, infection, pneumothorax or arrhythmias)	up to 7 days
Secondary	Morphine equivalents taken	Morphine equivalents taken during the inpatient period	up to 7 days
Secondary	Number of narcotics taken	Number of narcotics taken post discharge	7 days to 3 months
Secondary	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