Evaluation of the Effectiveness of tDCS in the Management of Perioperative Pain

The purpose of this study is to determine whether a new medical technology can help reduce post-operative pain. The new technology is called Transcranial Direct Current Stimulation.

Study Overview

• Status: Completed
• Conditions: Post-Operative Pain
• Intervention / Treatment: Device: tDCS

Detailed Description

This study aims to evaluate the effectiveness of transcranial direct current stimulation (tDCS) in the management of postoperative pain. Specifically, this study will determine whether patients undergoing any type of inpatient surgical procedure that routinely requires at least a 1-day inpatient stay post-operatively will report less pain and use less opioid analgesics following a series of 20-minute sessions of tDCS (compared to sham tDCS) delivered up to twice per day post-operatively. In addition to comparing the effects of real tDCS to sham tDCS, the present study will evaluate the interaction of dose (number and frequency of tDCS sessions) and surgery type.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Brain Stimulation Laboratory, Institute of Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years-75 years of age
• surgery at Medical University of South Carolina
• at least 2 days of post-operative stay

Exclusion Criteria:

• history of seizures or epilepsy
• family history of seizures
• taking any medications shown to lower seizure threshold
• metal implants above the waist
• pregnant
• brain tumors or lesions
• pacemaker

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Real tDCS:Active Comparator; For Real tDCS, stimulation will be delivered in 20-minute-sessions using 2mA current. The anode will be placed over left BA9 or the motor cortex corresponding with the painful area (if applicable). The cathode will be placed over right BA43 (for GI pain) or right BA9 (located via the international 10-20 EEG system).	Device: tDCS; 20 minutes of either real or sham stimulation
Experimental: Sham tDCS: Sham Comparator; For sham tDCS, the device will be turned on for 30 seconds and then turned off for the duration of the 20-minute session.	Device: tDCS; 20 minutes of either real or sham stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Controlled Analgesia (PCA) Hydromorphone Usage	The PCA pump usage was downloaded from the PCA pump after discharge from the hospital.	Participants were followed for the duration of hospital stay, an average of 48 hours.
Average Pain at Least	To assess each participant's average pain at it's least in the past 24 hours, The Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their average pain at it's least in the past 24 hours using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain.	Baseline and Discharge
Average Pain at Worst	To assess each participant's average pain at it's worst in the past 24 hours at Baseline, The Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their average pain at it's worst in the past 24 hours using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain.	Baseline Only
Average Pain	To assess each participant's pain on average in the past 24 hours at Baseline, The Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their pain on average in the past 24 hours using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain.	Baseline Only

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Jeffrey Borckardt, Ph.D., Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: April 26, 2012
• First Submitted That Met QC Criteria: May 21, 2013
• First Posted (Estimate): May 23, 2013

Study Record Updates

• Last Update Posted (Actual): August 7, 2018
• Last Update Submitted That Met QC Criteria: July 9, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: HR18682