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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Post-Operative Pain

Intervention / Treatment
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* Device: tDCS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real tDCS:Active Comparator<br>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<br>* 20 minutes of either real or sham stimulation<br>|
| Experimental: Sham tDCS: Sham Comparator<br>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<br>* 20 minutes of either real or sham stimulation<br>|

What is the study measuring?
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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 |