N/A
N=10
Feasibility Study for Intrathoracic Nerve Stimulation
Postoperative Pain
Bottom Line
View on ClinicalTrials.gov: NCT04066374 ↗Enrolled (actual)
10
Serious AEs
40.0%
Results posted
Jul 2024
Primary outcome: Primary: Pain as Measured by the Visual-analog Scale — 1 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Peripheral Nerve Stimulation (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain as Measured by the Visual-analog Scale |
1 | — |
| PRIMARY Freedom From Device Related Adverse Events |
0; 1; 1; 0 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04066374). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.