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

Not Applicable

Completed

• Conditions: Post-Operative Pain

• Registration Number: NCT01861587
• Lead Sponsor: Medical University of South Carolina

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.

Study Timeline

• Study First Submitted: 2012-04-26
• Study First Submitted QC: 2013-05-21
• Study First Posted: 2013-05-23
• Study Start: 2014-10
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Results First Submitted: 2016-04-08
• Results First Submitted QC: 2018-06-12
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-09
• Results First Posted: 2018-07-10
• Last Update Posted: 2018-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Average Pain at Worst	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	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	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	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.

Trial Locations

Locations (1)

Brain Stimulation Laboratory, Institute of Psychiatry; 🇺🇸 Charleston, South Carolina, United States