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NCT04066374

Feasibility Study for Intrathoracic Nerve Stimulation

Completed NA Results posted Last updated 9 July 2024
What this trial tests

NA trial testing Peripheral Nerve Stimulation in Postoperative Pain in 10 participants. Completed in 11 June 2024.

Timeline
13 August 2019
Primary endpoint
9 January 2024
11 June 2024

Quick facts

Lead sponsorThe Cleveland Clinic
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment10
Start date13 August 2019
Primary completion9 January 2024
Estimated completion11 June 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

The Cleveland Clinic

Who can join

22 and older, any sex, with Postoperative Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pain as Measured by the Visual-analog Scale Primary · Baseline to 3 months

Pain level expressed by the study subject in the scale of 0 (no pain) to 10 (unbearable pain). Lower scores represent the better outcome.

GroupValue95% CI
Treatment Arm10 – 3
Freedom From Device Related Adverse Events Primary · up to 7 days

Freedom from device related adverse events (i.e., bleeding, infection, pneumothorax or arrhythmias)

Bleeding
GroupValue95% CI
Treatment Arm0
Infection
GroupValue95% CI
Treatment Arm1
Pneumothorax
GroupValue95% CI
Treatment Arm1
Arrhythmias
GroupValue95% CI
Treatment Arm0

Adverse events — posted to ClinicalTrials.gov

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.

Treatment Arm
Serious: 4/10 (40%)
Deaths: 0/10

Serious adverse events (6 terms)

ReactionSystemTreatment Arm
Pleural EffusionRespiratory, thoracic and mediastinal disorders
Acute Kidney InjuryRenal and urinary disorders
COPDRespiratory, thoracic and mediastinal disorders
PneumothoraxRespiratory, thoracic and mediastinal disorders
EmphysemaRespiratory, thoracic and mediastinal disorders
PneumoniaRespiratory, thoracic and mediastinal disorders
Other adverse events (4 terms — click to expand)

ReactionSystemTreatment Arm
DiscomfortGeneral disorders
DiscomfortGeneral disorders
Pleural EffusionRespiratory, thoracic and mediastinal disorders
Abdominal PainGastrointestinal disorders

Most-reported serious reactions: Pleural Effusion, Acute Kidney Injury, COPD, Pneumothorax, Emphysema, Pneumonia.

Data from ClinicalTrials.gov NCT04066374 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Peripheral Nerve Stimulation

Trials testing the same drug.

Other recruiting trials for Postoperative Pain

Currently open trials in the same condition.

Other The Cleveland Clinic trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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