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Clinical Trials/NCT01861587
NCT01861587
Completed
Not Applicable

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

Medical University of South Carolina1 site in 1 country27 target enrollmentOctober 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post-Operative Pain
Sponsor
Medical University of South Carolina
Enrollment
27
Locations
1
Primary Endpoint
Average Pain at Worst
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
October 2014
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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
  • brain tumors or lesions
  • pacemaker

Outcomes

Primary Outcomes

Average Pain at Worst

Time Frame: Baseline Only

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.

Patient Controlled Analgesia (PCA) Hydromorphone Usage

Time Frame: Participants were followed for the duration of hospital stay, an average of 48 hours.

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

Average Pain at Least

Time Frame: Baseline and Discharge

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.

Average Pain

Time Frame: Baseline Only

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.

Study Sites (1)

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