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

Medical University of South Carolina27 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Post-Operative Pain

Interventions

tDCSDEVICE

20 minutes of either real or sham stimulation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Brain Stimulation Laboratory, Institute of Psychiatry

Charleston, South Carolina, United States

Outcomes

Primary Outcomes

Patient Controlled Analgesia (PCA) Hydromorphone Usage

The PCA pump usage was downloaded from the PCA pump after discharge from the hospital.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline Only

Data from ClinicalTrials.gov

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