Pain level expressed by the study subject in the scale of 0 (no pain) to 10 (unbearable pain). Lower scores represent the better outcome.
| Group | Value | 95% CI |
|---|---|---|
| Treatment Arm | 1 | 0 – 3 |
Last reviewed · How we verify
Feasibility Study for Intrathoracic Nerve Stimulation
NA trial testing Peripheral Nerve Stimulation in Postoperative Pain in 10 participants. Completed in 11 June 2024.
| Lead sponsor | The Cleveland Clinic |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 13 August 2019 |
| Primary completion | 9 January 2024 |
| Estimated completion | 11 June 2024 |
| Sites | 1 location across United States |
The Cleveland Clinic
22 and older, any sex, with Postoperative Pain. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Pain level expressed by the study subject in the scale of 0 (no pain) to 10 (unbearable pain). Lower scores represent the better outcome.
| Group | Value | 95% CI |
|---|---|---|
| Treatment Arm | 1 | 0 – 3 |
Freedom from device related adverse events (i.e., bleeding, infection, pneumothorax or arrhythmias)
| Group | Value | 95% CI |
|---|---|---|
| Treatment Arm | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment Arm | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment Arm | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment Arm | 0 |
Time frame: Time of procedure to 3-months post-op visit. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Treatment Arm |
|---|---|---|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | — |
| Acute Kidney Injury | Renal and urinary disorders | — |
| COPD | Respiratory, thoracic and mediastinal disorders | — |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | — |
| Emphysema | Respiratory, thoracic and mediastinal disorders | — |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | — |
| Reaction | System | Treatment Arm |
|---|---|---|
| Discomfort | General disorders | — |
| Discomfort | General disorders | — |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | — |
| Abdominal Pain | Gastrointestinal disorders | — |
Most-reported serious reactions: Pleural Effusion, Acute Kidney Injury, COPD, Pneumothorax, Emphysema, Pneumonia.
Data from ClinicalTrials.gov NCT04066374 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04066374.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing