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

NCT03005548 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2018-03-29

No results posted yet for this study

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.

Conditions

  • Pain, Postoperative

Interventions

DEVICE

Transcranial direct current stimulation

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.

DRUG

Morphine

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.

Sponsors & Collaborators

  • Military Medical Academy, Belgrade, Serbia

    lead OTHER

Principal Investigators

  • Tihomir V Ilic, MD, PhD · Military Medical Academy, Bulgaria

  • Dusica M Stamenkovic, MD, PhD · Military Medical Academy, Bulgaria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2017-12-31
Completion
2018-01-31

Countries

  • Serbia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03005548 on ClinicalTrials.gov