Cortical Modulation of Acute Post-thoracotomy Pain With Transcranial

Status Completed

Clinical Trial 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.

Clinical Trial Description

tDCS has been used for treatment of chronic pain states, but experience with the use of tDCS for treatment of acute postoperative pain is limited. tDCS has been used for postoperative analgesia after lumbar spine surgery, total knee arthroplasty and for post-procedural pain after endoscopic retrograde cholangiopancreatography.

This study investigates the effects of tDCS vs. sham stimulation combined with IV morphine PCA on postoperative morphine consumption for analgesia after thoracotomy for lung cancer.

Patients with malignant lung disease requiring thoracotomy will be randomly assigned to active stimulation or sham stimulation in a double-blind, sham-controlled, parallel design clinical trial. Each group will receive IV morphine PCA and tDCS vs. IV morphine PCA and sham stimulation daily, starting with arrival in the post-anesthesia care unit on the day of surgery and continuing for the first four postoperative days. Anodal tDCS with direct current at intensity 2 mA will be delivered for 20 minutes on five consecutive days, whereas sham stimulation will last for 30 seconds.

Morphine consumption, the number of analgesia demands, and pain intensity at rest, during movement and with cough will be recorded at predetermined time intervals as follows: After surgery, when VAS pain score at rest falls below 30 mm, tDCS will be applied. VAS pain will be measured immediately before the intervention (T0) and immediately after the intervention (T1), and then regularly every one hour for the four hours (Т2-Т5), and then every six hours (Т6-Т9) for five days. ;

Study Design

Related Conditions & MeSH terms

Pain, Postoperative

Clinical Trial Details

NCT number	NCT03005548
Study type	Interventional
Source	Military Medical Academy, Belgrade, Serbia
Contact
Status	Completed
Phase	Phase 2
Start date	June 2016
Completion date	January 2018

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05480111` - The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy	Phase 4
Completed	`NCT06129305` - Erector Spina Muscle Distance From the Skin at Different Thoracal Elevations
Completed	`NCT04401826` - Micro-surgical Treatment of Gummy Smile	N/A
Recruiting	`NCT04020133` - the Role of Popliteal Plexus Block in Pain Management After Anterior Cruciate Ligament Reconstruction.	N/A
Completed	`NCT03023462` - Efficacy of an Anterior Quadratus Lumborum Block vs. a TAP-block for Inguinal Hernia Repair	N/A
Completed	`NCT03652103` - Efficiency of Erector Spinae Plane Block For Patients Undergoing Percutaneous Nephrolithotomy	Phase 4
Completed	`NCT03546738` - Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery	N/A
Withdrawn	`NCT03528343` - Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy	Phase 1/Phase 2
Terminated	`NCT03261193` - ITM + Bupivacaine QLB vs. ITM + Sham Saline QLB for Cesarean Delivery Pain	Phase 3
Completed	`NCT02525133` - Phase 3 Study of Efficacy and Safety of the XaraColl® Bupivacaine Implant After Hernioplasty	Phase 3
Completed	`NCT03244540` - Regional Analgesia After Cesarean Section	Phase 4
Enrolling by invitation	`NCT05316168` - Post Operative Pain Management for ACL Reconstruction	Phase 3
Recruiting	`NCT04130464` - Intraperitoneal Infusion of Analgesic for Postoperative Pain Management	Phase 4
Enrolling by invitation	`NCT04574791` - Addition of Muscle Relaxants in a Multimodal Analgesic Regimen for Analgesia After Primary Total Knee Arthroplasty	N/A
Completed	`NCT04526236` - Influence of Aging on Perioperative Methadone Dosing	Phase 4
Completed	`NCT04073069` - Scalp Infiltration With Diprospan Plus Ropivacaine for Postoperative Pain After Craniotomy in Adults	Phase 4
Recruiting	`NCT05351229` - Intrathecal Morphine for Analgesia in Video-assisted Thoracic Surgery	Phase 4
Enrolling by invitation	`NCT05543109` - Ultrasound Guided Psoas Compartment Block vs Suprainguinal Fascia Iliaca Compartment Block	N/A
Completed	`NCT05346588` - THRIVE Feasibility Trial	Phase 3
Completed	`NCT04919317` - Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms