CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 62 enrolled
Drug / intervention
Morphine +1 moredrug
Likely dose
Morphine 1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03005548
NCT03005548Phase 2Completed

Cortical Modulation of Acute Post-thoracotomy Pain With Transcranial Direct Current Stimulation

Military Medical Academy, Belgrade, Serbia·interventional·Posted Dec 29, 2016·Updated Mar 29, 2018

In Brief

A Phase 2 clinical trial evaluating Transcranial direct current stimulation and Morphine for Pain, Postoperative. Completed, enrolled 62 participants across 1 site.

Detailed Summary

The primary objective of this single center, prospective, randomized, double blind clinical trial is to evaluate the effectiveness of anodal transcranial direct current stimulation (tDCS) combined with patient controlled analgesia (PCA) morphine, on intravenous morphine use for postoperative analgesia after thoracotomy. The intervention group will receive treatment with anodal tDCS, whereas the control group will receive sham stimulation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSerbia
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 29, 2016
Enrollment StartJun 1, 2016
Primary CompletionDec 1, 2017
Study CompletionJan 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 9.5 years ago

Interventions

Transcranial direct current stimulationdevice

Transcranial direct current stimulation. All eligible patients will be treated with patient-controlled IV morphine analgesia by PCA (PCA pump (CADD-Legacy PCA Pump, Deltec, Inc.) IV morphine bolus 1 mg, lockout time 10 mins.). Device: wireless tDCS (StarStim, NeuroElectrics) non-invasive brain stimulation with a pair of electrodes with saline-soaked pads for delivery of direct current at intensity 2 mA for 20 mins.

Morphinedrug

In Sham comparator group All eligible patients will be treated with patient-controlled IV morphine analgesia (PCA) (PCA pump (CADD-Legacy PCA Pump (Deltec, Inc.) morphine IV bolus 1 mg, lockout time 10 mins). Device: wireless tDCS (StarStim, NeuroElectrics) non-invasive brain stimulation with a pair of electrodes with saline-soaked pads for delivery of direct current at intensity 2 mA for 30s at the beginning.